In brief:

• The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings.
• Randomized clinical trials are deemed as a gold standard method for analyzing and evaluating the safety and effectiveness of medical devices or pharmaceutical drugs.
• The most challenging part of conducting a randomized clinical trial are related to handling ethical and regulatory systems.

Clinical study trial is majorly comprising of four components which include study design, the conduct of the clinical trial, analysis of acquired data and reporting the results. In this article, we will discuss the details of the major components and the challenges that come at every stage and finally, the limitations and future prospects.

Randomized clinical trial (RCT) is considered as the gold standard method to understand the medical interventions by evaluating the effectiveness of the treatment and the safety of the patients or participants. In clinical research, studies like RCT are known for the evidence-based decision making, and a well-constructed clinical trial study will provide with the most reliable data with the effectiveness of clinical interventions. Although, RCT is the reliable method for measuring the effectiveness, the quality of these studies has always been considered because of its multidisciplinary nature and the multistep process as they face different challenges that vary among countries.

The basic principle in conducting clinical research is that the data collection must be keenly monitored as it is the major source of information that will later be analyzed. Such monitoring helps in avoiding the bias later and ensures the risk of the patients or participants present in the clinical trial study. This can also be mentioned as a challenging section in conducting a clinical study, and many institutions conducting the study have less awareness of the research priorities and conducting the study in developing countries often cause infrastructural barriers, ethical and cultural issues, organizational problems, etc.

The analysis of randomized clinical trials can be misleading by the timeliness or the poor design of study design and misinterpretation of well-designed randomized clinical trials. Besides, several limitations such as physician competence, faults in the patient selection process, applicability, randomization, and the populations used for study can also affect the effectiveness of the clinical study and produce misleading results.

The major challenges in conducting randomized clinical studies are associated with patient recruitment suitable for the clinical research, barriers in handling ethical concerns and regulatory systems, lack of skilled support staffs and experienced clinical investigators, lack of infrastructure, awareness and motivation and lack of time for conducting a clinical trial study, and these challenges can be avoided using a complete well-driven planning, proper design of the study and support from a contract research organization.

On the future prospect, the randomized clinical trial must adapt to the situation and evolve in responding to the environmental changes so as to conduct a high-quality clinical trial study. In addition, a collaborative effort will also drive the clinical research in the right direction, and by reconsidering the existing challenges, a clinical trial study should arise with innovation from utilizing the shared patient data to drive the development of medical technologies and pharmaceutical drugs for the human use. However, the obtained clinical trial data should be protected with robust technologies, and individual privacy must also be considered.

Reference:

1. Fatemeh Varse, Leila Janani, Yousef Moradi, Masoud Solaymani-Dodaran, Hamid Reza Baradaran, and Shahnaz Rimaz, Challenges in the design, conduct, analysis, and reporting in randomized clinical trial studies: A systematic review, Med J Islam Repub Iran. 2019; 33: 37.
2. London L, Hurtado-de-Mendoza A, Song M, Nagirimadugu A, Luta G, Sheppard VB. Motivators and barriers to Latinas’ participation in clinical trials: the role of contextual factors. Contemporary clinical trials. 2015;40:74–80.
3. McKenzie JE, Herbison GP, Roth P, Paul C. Obstacles to researching the researchers: A case study of the ethical challenges of undertaking methodological research investigating the reporting of randomized controlled trials. Trials. 2010;11(1):28.
4. Hans-Georg Eichler, Fergus Sweeney, The evolution of clinical trials: Can we address the challenges of the future?, Volume: 15 issues: 1_suppl, page(s): 27-32
5. SchuylerJonesMD et al., The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease, Journal of the American College of Cardiology, Volume 68, Issue 17, 25 October 2016, Pages 1898-1907.

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In brief:

• The clinical study protocol is defined as the procedures by which clinical research is conducted
• A clinical study protocol should provide a clear clinical study design to meet the objective of the clinical trial
• A defined protocol must address the proposed medical question and protect the safety and rights of the clinical trial participant/patients

Introduction

Clinical trials are aimed at evaluating new pharmaceutical drugs, medical devices, and surgical materials, and it is the primary process in identifying the safety and effectiveness of new drugs or devices like a pacemaker for human use. In many cases, clinical trials are used to understand the effectiveness of new drug/devices and damaging side effects. Clinical trials are also conducted in diagnosing diseases early to prevent the severity of the disease conditions. Every new finding of medical drugs and devices goes through four phases of clinical trials to find the appropriate dosage value and the corresponding side effects.

During phase I, the clinical trial experiments will be carried out with a small group of participants to test the safety and side effects to find the accurate dosage value. In phase II, will be testing the effectiveness and obtain preliminary data of curing rate and study the short-term side effects. In phase III, the drug will be tested in a large group to collect more data on safety, effectiveness, side effects related to dosage range with different age groups and disease severity. Upon approval from the FDA at this stage, phase IV will be permitted to carry out with a diverse population for a prolonged period for a detailed study.

Challenges in writing clinical protocol:

The clinical trial protocol is a well-defined procedure of the study, and it must provide a clear & concise design to meet the objective of the study. The protocol for trials evaluating pharmacological drugs, medical devices, and surgical instruments requires complex details that describe ethical, medical and regulatory functions of the clinical trial. In addition, the contributions of medical experts, regulatory experts, statisticians, pharmacokineticists and operational experts are mandatory in protocol development and to address the proposed medical questions.

Writing a well-communicated clinical trial protocol is often challenging, and International Council for Harmonisation Good Clinical Practice provided certain recommendation like what needs to be included in the protocol, structure of clinical study protocol and the standards. Thus, by this time, an experts guidance from Pepgra is preferable as they are experienced in writing many protocols by following clinical protocol structures such as SPIRIT statement and TransCelerate common protocol template and our experts follow ICH E9 standard procedure for a well-constructed clinical trial protocol for all therapeutic area.

General guidelines in writing the clinical protocol:

1. Introduction:

The introduction must have detailed literature review covering the existing therapeutic options and test methods.

This section should present the scientific rationale of the clinical trial and identifying the primary purpose includes the aim to achieve and the importance of the clinical study.

2. Objective:

This section should state the objective in the form “SMART”. For a clear delivery of the objective, our experts divide it into a primary, secondary and exploratory category. In which the primary will deliver the aims to answer clinical trial purpose directly, and secondary will explain the associated actions with the rationale. Finally, the exploratory will state the hypothesis-generating objectives that can be analysed with additional studies.

3. Population:

Every clinical trial protocol should define the targeted population who will be used for the trial includes the geographical region and a detailed list of inclusion and exclusion criteria which specifies age, sex, BMI and medical conditions.

4. Endpoints:

It is defined as an indicator in measuring a biological sample (in this case patient) to assess effectiveness and safety or side effects. In all cases, there should be an endpoint which exactly matches the objective of the study to ensure that the correct variables are measured. In a clinical trial study, variables are parameters which include safety, clinical efficacy, treatment, age, sex, BMI, smoking history, and health outcomes.

5. Trial design:

The clinical trial design will indicate the participant’s treatment and the number of required groups for treatment and data collections. If the proposed trial is for the second or third phase, the trial should briefly describe the single group design, which explains the variables comparing the primary phase participants with the exposure to the test treatment. The trial design also needs to ensure the presence of bias minimization. If randomization or blinding are not used in the comparative trial, then bias minimization techniques should be justified in the clinical protocol.

6. Control groups:

In the clinical trial protocol, this section explains the control groups and the target population should be clearly identified and justified, and the control group must be aligned with the clinical trial design and objective. Besides, all the experimental tests, including placebo, must be clearly characterized and identified in the clinical trial protocol.

7. Statistical considerations:

This section in the protocol should explain the rationale for the calculated sample size with the clinical and statistical assumptions based on the primary endpoint and the statistical analysis must present the complete details of summaries for all endpoints along with the details of the statistical analysis plan. To tackle all the complexity in writing a clinical protocol statistical consideration, we provide statistician support, and when applicable we offer other support, and we have experts like pharmacodynamics/pharmacokinetics experts, quality of life expert, and clinical writing expert.

Conclusion:

In summary, the clinical protocol is the procedure by which the trial is conducted, and the writing requires a wide amount of assessment on all concepts related to the trial. Pepgra has understood the complexity of developing a complete clinical trial protocol with experts. Our team of experts will thus protect the scientific integrity of the trial and the safety of the participants.

Reference:

1. Chan A, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med. 2013;158(3):200–7.DOI: 10.7326/0003-4819-158-3-201302050-00583.

2. Al-Jundi A, Sakka S. Protocol Writing in Clinical Research. J Clin Diagn Res. 2016;10(11): ZE10–3.DOI: 10.7860/JCDR/2016/21426.8865

3. Patino CM, Ferreira JC. Inclusion and exclusion criteria in research studies: definitions and why they matter. J Bras Pneumol. 2018;44(2):84.DOI: 10.1590/s1806-37562018000000088.

4. Jensen JS, Bielefeldt AØ, Hróbjartsson A. Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: a methodological overview. J Clin Epidemiol.2017;87:35–46.DOI: 10.1016/j.jclinepi.2017.03.001.

5. Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019;72(3): 221–32.DOI: 10.4097/kja.19049

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Brief:

Have a look at post-authorization safety studies and important pharmacoepidemiological and pharmacovigilance aspects in clinical research in this Pepgra blog.

PASS covers different types and limitations of surveillance programs, such as the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approach for causal interference from observational information

Introducing Post-Authorization Safety Studies (PASS):

A PASS, an authorization of a study carried out after a medicinal product, to obtain further information on a medicinal product’s safety or to measure the effectiveness of risk-management measures

The purpose of the PASS is to evaluate the safety and benefit-risk profile of a medicinal product and to support regulatory decision-making

The protocols and results of PASS’s access is with the Pharmacovigilance Risk Assessment Committee (PRAC)

Aims of PASS:

• Identify, characterize, or quantify a safety hazard;
• Confirm the safety profile of a medicine; or,
• Measure the effectiveness of risk-management measures.
• PASSs can either be clinical trials or non-interventional studies.

Under the EU legislation, a post-authorization study is classified as a PASS when the main aims for initiating the study include:

• Quantification of risks or providing evidence about the absence of risks
• Evaluation of risks in populations with limited or missing safety data
• Assessment of patterns of drug utilization that gives information on the safety profile
• Measurement of the effectiveness of a risk minimization activity

The British Journal of Pharmacology analysis showed that 74% of PASS had a focus on investigating safety concerns, while 34% focused on drug utilization, and 25% on the effectiveness of risk minimization.

In one-third of the PASS, more than one of these objectives present in the protocol. Some 35% of the PASS had effectiveness endpoints as well as safety ones.

It may reflect the fact that PASS is expensive and long-term commitments for sponsors, with the result that it is desirable to capture routine effectiveness data in the real world.

Concerning the study population, 12% of the overall PASS are of pregnancy registries, and 18% included pediatric patients only. Also, 22% of PASS targeted healthcare professionals, with the great majority of these (94%) aimed at assessing the effectiveness of risk minimization efforts and drug utilization.

Actions to foster PASS collaboration and bridge pharmacovigilance and pharmacoepidemiology

The currently available information on PASS offers critical insights into design and conduct of PASS under the new European pharmacovigilance legislation. The new analysis indicates that there is scope for further improvements in transparency from both regulators and MAH. The EMA could increase the availability of protocol assessments within the EU-PAS, while PASS sponsors could improve access to and documents in the register. The large number of PRAC comments involving in the methodological issues and feasibility concerns should alert PASS stakeholders for the need for improved study design, based on current guidelines and pharmacoepidemiological principles. Looking ahead, it will be vital to building cooperation between PASS stakeholders to support transparent and methodologically sound studies that align with other risk management approaches. This collaborative generation of knowledge will be integral to strengthening the capacity of the EU to deliver better and safer therapies.

Changes in PASS:

 Transparency:

The EMA is working on new mechanisms to increase data transparency and compliance by sponsors with ENCePP standards and requirements (code of conduct, checklists, EU-PAS registration). Key will be better promotion of ENCePP Study Seal, a quality mark designed to recognize high standards throughout the research process based on the principles of robust methodologies, transparency and scientific independence.

 Methodology:

A considerable number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders of the need to design more thoughtful studies, according to pharmacoepidemiological principles and existing guidelines. Currently, most PASS is detailed studies, involving a simple, long-term, descriptive analysis of patients who have taken the drug, with no comparator. Hybrid studies involving both primary and secondary data collection present more frequently in future. Today’s pharmacoepidemiological toolbox offers many additional options, such as the ability to model links between exposure and outcomes. Such approaches could improve the design of PASS. Also, new guidelines for post-authorization efficacy studies (PAES) 8 have just been released, with a final version expected in 2017; this is likely to lead to increasing numbers of requests by regulatory authorities for PAES in addition to PASS. Clinical trial design options for designing of PAES includes explanatory and pragmatic trials.

Definitions:

In the EU Clinical Trial Regulation, the new description of  PASS will rise into effect, impacting classification of it. It results in, and some studies classification will be observational studies, resulting in a different review process and pose a challenge for study sponsors in the coming year. Also, when the new clinical trial regulation comes into force, it will become essential to scrutinize possible rules in the ethics committee decision-making across Europe and their impact on the conduct and the implementation of PASS.

Governance:

In future, there will be more joint studies involving multiple products, sponsors, academics and CROs within a therapeutic category. Such tasks will need new governance structures. EU initiatives, such as the IMI accelerates the development of vaccine benefit-risk collaboration in Europe (ADVANCE) project. The EMA initiative for patient registries represents promising opportunities to expand joint efforts using new governance models, with the potential to deliver robust results with statistical significance.

Conclusion

These are the few important topics that every clinical researcher should possess knowledge of post-authorization services. Pepgra has stated many essential aspects and changes in the clinical research field to help healthcare data analytics services.

References:

1. Cohet, C., Rosillon, D., Willame, C., Haguinet, F., Marenne, M. N., Fontaine, S., … & Baril, L. (2017). Challenges in conducting post-authorization safety studies (PASS): A vaccine manufacturer’s view. Vaccine, 35(23), 3041-3049.
2. Huberlant, B., KWADE, Z., & VAN RIEL, A. N. N. I. C. K. (2011). Post authorization safety studies (PASS); Updated EU regulations. LIFE SCIENCE I TECHNICAL BULLETIN. ISSUE N, 42.

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• Real-world evidence, which is based on data gathered during routine clinical exercise, has the potential to make a significant impact in nearly every phase of a drug’s life.
• There are so many benefits of real-world evidence in the clinical research field and also used for pharmacovigilance literature search service.
• In this medical literature review, Pepgra focuses on the beneficial impacts of drug development using real-world evidence, conducting a global literature search, and providing scientific literature search services for all the clinical research works.

Introduction

The role of RWE in drug development is growing, driven partially by biotechnology and drug makers’ hug of advanced answers for acknowledging gains in speed and effectiveness from growth. RWE groups have flourished across the drug business with industry-wide interest’s inability and specialized framework. Fruitful biopharmaceutical organizations have coupled venture with the conviction that RWE is an essential segment of improvement and life-cycle the executives, and focused on this by building RWE-age abilities for a vast scope. Suppliers have correspondingly accepted RWE to educate clinical practice, and clinical rules progressively fuse RWE-produced bits of knowledge using pharmacovigilance services. Perceiving the requirement for a more flexible structure for treatment assessment, controllers create ways to join. These progressions are joined by excellent data suppliers’ development, incorporating unmistakable data sources and insightful methodologies.

Drug development using real-world evidence:

Expanding the indications for approved therapies:

Certifiable data can give powerful proof to growing the affirmed employments of medication to new kinds of patients and recent illnesses. The evidence can be utilized to help interests in clinical investigations to acquire endorsement for new signs. Moreover, the FDA deals with approaches to characterize when such data might be fused in the endorsement cycle for new characters.

The reserve funds as expected and cash would be impressive. “Rather than doing a $10 million clinical preliminary that could require a very long time to finish, we may have the option to do a one-year, $1 million data study that would be more educational. “The FDA is welcoming patrons to approach with a proposition for utilizing certifiable proof to help new signs, after conducting a literature surveillance in pharmacovigilance.

Designing more effective and successful clinical trials:

In planning preliminaries, drug advancement groups should set up standards to incorporate or bar various patients. Real data can show the effect of multiple criteria on the possible pool of patients. “On the off chance that your measures are too restricting, the data may indicate that you’ve barred the more significant part of the patients with the infection you’re contemplating. Utilizing data to advance the models can help quicken quite an enrollment and guarantee substantial outcomes.

Data can likewise give direction on how enormous and long a research should permit a test medication to show an effect on illness results from a medical literature review. “At the point when you’re contemplating how to control a research, “it’s beneficial to realize the foundation pace of various results in the patients you intend to remember for the investigation.” Real-world data can give you that data and guarantee an investigation has the correct size and span.

Protecting the safety of patients:

Real data is generally used to enlarge preliminary clinical data in deciding a medication’s wellbeing profile. The data can be beneficial in estimating the danger of exceptionally uncommon yet possibly real results. “For certain drugs, the dangers of most interest to controllers may happen in one out of each couple of thousand patients”. “To accumulate important data on these dangers, you would have to consider countless patients, and you were unable to do a clinical report that enormous.”

All things being equal, organizations have been working with organizations that plan electronic clinical records to use health-related inquiries into EMRs. Doctors are incited to get some data about potential unfavorable occasions when they meet with patients utilizing certain meds. “We’re installing concentrates inside the EMRs to supplant all the more expensive yet less productive pharmacovigilance programs”. “We’re not merely dissecting data that is as of now out there.

Making Real-World Data Widely Available:

Many organizations utilizing real word data to recognize patients whose necessities aren’t being met by current treatments; to streamline incorporation and avoidance models for preliminaries to help speed enlistment of patients and guarantee essential outcomes. And to show how well various meds passage in assisting individuals with remaining gainful and dependable.

The clinical organizations dispatched a Real-World Data Portal three years back to furnish the organization’s drug development groups with prepared admittance to valuable data. The gateway takes advantage of anonymized records from more than 150 million patients. Complex questions can be executed and replied in minutes or seconds. “You can get the age appropriation for individuals with a given sickness just as different illnesses they have and the prescriptions they are utilizing. The gateway has produced popularity inside the organization and acknowledgement remotely.

Post-market surveillance and studies:

Post-endorsement studies and reconnaissance can be restrictively costly for drug designers. “Incorporating RWE and preliminary clinical proof into a continuous life cycle, the executive’s procedure can significantly decrease the interest for, and cost of, post-statistical surveying.”

Early drug discovery:

RWE can be utilized from the get-go in medication revelation and improvement programs, encouraging item advancement by recognizing sicknesses or signs that address a critical weight in population,” on a real proof. RWE can prospect components of early revelation by zeroing in on ID of high-reacting quiet companions. RWE investigations can distinguish biomarkers of restorative reaction and protection from advance a drug development system utilizing robust genomic sequencing data and longitudinal clinical data. Utilization of such discoveries can advise biomarker focuses of interest and, later on, may uphold more focused on medication advancement.

Conclusion:

These are just a few ways RWE can positively affect drug development, from improving treatments to cutting costs. Pepgra focuses on the beneficial impacts of drug development using real-world evidence, conducting a global literature search and also provides pharmacovigilance literature search services for all the clinical research works.

References:

1. Corrigan-Curay, J., Sacks, L., & Woodcock, J. (2018). Real-world evidence and real-world data for evaluating drug safety and effectiveness. Jama, 320(9), 867-868.
2. Epstein, R. S., Sidorov, J., Lehner, J. P., & Salimi, T. (2012). Integrating scientific and real-world evidence within and beyond the drug development process. Journal of comparative effectiveness research, 1(1s), 9-13.

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• The best clinical trial recruitment strategies start by focusing on the patient perspective. From there, it helps to get creative.
• A reliable clinical trial patient recruitment plan incorporates a range of outreach methods designed to quickly and efficiently reach patients while providing them with the information they need to take the next step.
• Pepgra give tips to clinical trial patient recruitment in this blog and also offers patient recruitment for clinical trials or the patient recruitment companies

Introduction:

As you know, clinical trials drive medical research accelerative. But as experts in finding practical answers to the clinical trial business, we know it can take a lot of effort to get capable patients recruited for the work. Good results in patient recruitment rest on a matching act. Structure and flexibility, skill and personability, competence and thoughtfulness – these are just some of the theoretical antonyms that make up the most effective patient enrolment process.

Top 10 patient recruitment tips for clinical trials                                                             

Understand what matters the most to patients

In a perfect world, the patient voice is remembered for an examination’s plan to guarantee that it meets open clinical research patient recruitment. On the off chance that a preliminary does exclude endpoints that are significant to patients, it makes enrollment considerably all the more testing. In case you’re working with a patient recruitment organization, gets some information about how they separate their effort approaches relying upon the preliminary condition zone. An essential organization will keep these patient inclinations on top of the brain while making effort materials and choosing their focusing.

Share your trial with a local health care provider

Another patient-driven way to deal with recruitment is to associate with essential consideration suppliers and trained professionals. Consider assembling effort materials with relevant preliminary data planned explicitly for specialists. On the off chance that your site has associations with neighbourhood medical clinics or other medical care suppliers in the zone, utilize your organization to get the message out about your preliminary. You can likewise arrive at patients at purpose of-care through offices that give promoting in specialist’s workplaces.

Connect with nonprofit partners    

Working with neighbourhood charitable accomplices and other people who draw in with support networks can help you arrive at patients in your general vicinity who may not be in your site’s information base as of now. Our exploration has found that patients are likewise bound to believe data about preliminaries they get through not-for-profits associations contrasted and promotions.

The expense of working with accomplices differs: a few associations might be keen on advancing your preliminary for a charge, while others may offer free or minimal effort advancements. For instance, you might have the option to join nearby wellbeing reasonable or different occasions to advance your preliminary. Or on the other hand, a not-for-profit association might be keen on elevating your primary to their email list for an expense.

Work with patient-centric clinical trial recruitment 

The meaning of “tolerant driven” can shift from individual to individual; however, while assessing clinical preliminary recruitment organizations, have questions arranged that get to the core of the organization’s relationship with patients. Do outreach materials they’ve made in the past mirror the patient populace? Do they react to questions using web-based media stages or email from patients about the preliminary and how responsive would they say they are? Does the merchant have associations with understanding backers or different gatherings? Understanding an enrollment organization’s relationship with patients can help you determine whether their strategies will associate you with connected patients.

Run digital recruitment campaigns

Computerized promoting offers preliminary groups the chance to arrive at patients’ past site data sets and inform that best associate with the intrigued individuals.

A significant all-encompassing advantage of advanced patient recruitment is the capacity to arrive at patients any place they are web based, including Facebook, Twitter, Quora, TikTok, Reddit, Pinterest, TikTok, and search stages like Google and Bing. At some random time, 3.5 billion web-based media clients on the planet are looking through the web’s tremendous news sources. It’s straightforward why these advanced stages bode well for drawing in patients around clinical preliminaries.

Provide lab service options

During the COVID-19 pandemic, discovering approaches to be creative with clinical preliminary patient enrollment has been the situation. One pattern we’re seeing is the ascent of virtual preliminaries, which has made it simpler and more secure for additional individuals to take an interest in examination. On the off chance that an analysis is generally virtual, the area turns out to be less of an issue.

Contact patients who match the criteria   

Arriving at patients who aren’t equipped for your preliminary isn’t merely expensive – it tends to be debilitating for patients, too. Sadly, when patients are told they don’t meet all particular clinical trial recruitment requirements, they may be reluctant to look for another primary. One approach to help improve tolerant qualification is to work with administrations to screen for testing consideration and rejection rules ahead of time. For instance, lab test and Electronic Health Record (EHR) organizations approach blood test data and other information patients are probably not going to know impromptu. Contacting patients who effectively meet these prerequisites can improve the patient experience and save time at the site level for clinical trial recruitment companies.

Screen for multiple trials 

In case you’re running numerous preliminaries for a similar condition territory, one approach to set aside time and cash is to screen for the entirety of the preliminaries without a moment’s delay. It should be possible by working with a patient enrollment organization that makes online pre-screeners and can coordinate patients dependent on their area and reactions to questions identified with consideration and avoidance models. Screening for numerous preliminaries on the double can help more intrigued patients associate research openings while accelerating the recruitment cycle.

Use patient follow-up 

While clinical preliminaries are top-of-mind for those running enrollment, for patients, your preliminary might be only one more email in their inboxes and thought in their bustling lives. Automated follow-up messages or instant messages can remind patients to make the following stride. Some patient enrollment organizations likewise offer subsequent administrations at the site level so that you can keep steady over the advancement patients are making and banner locales that are delayed to react. This kind of follow-up can help lower costs by lessening the number of patients who start the cycle and don’t finish, and save time by proactively reminding patients and destinations to make the following stride.

Consider patient’s retention

Preliminary groups see understanding enrollment and maintenance as independent ventures, yet they can likewise be considered a couple. For instance, commitment through electronic patient-revealed result devices can help patients feel more dedicated to partaking in a preliminary. Home visits to supplant excursions to a site or the chance to chat with specialists distantly can likewise help improve maintenance. Since these highlights can again help make it simpler to take an interest in a preliminary, it can bode well to feature them in effort materials to advance your primary.

Conclusion

Challenges in recruiting patients for clinical trials are not about one single thing. It’s about striking the equilibrium that works best. You want your recruitment process to be generous on the front end, and equally efficient on the backend. Pepgra helps you to improve the patient recruitment process in clinical trials.

References

1. Gross, C. P., Mallory, R., Heiat, A., & Krumholz, H. M. (2002). Reporting the recruitment process in clinical trials: who are these patients and how did they get there?. Annals of internal medicine, 137(1), 10-16.
2. Thoma, A., Farrokhyar, F., McKnight, L., & Bhandari, M. (2010). How to optimize patient recruitment. Canadian Journal of Surgery, 53(3), 205.

The post How to identify and recruit patients for secured clinical trials? Top 10 tips appeared first on pepgra.

• Clinical trials are the scientific way of assessing medications’ efficacy in treating a medical condition and side effects.
• EMA guidelines for clinical trial regulations adopted in 2014 aim to make it easier for the clinical trials companies while empowering participants through transparency.

Introduction to EMA & GCP

European Medicines Agency’s or EMA’s primary function is the authorization of pharmaceuticals or medicines in member states of the European Economic Area (EEA). EMA comes to such conclusions based on the data of clinical trials submitted by pharmaceutical companies.

EMA is not concerned with clinical trials’ authorization, but it is concerned with ensuring compliance with good clinical practice or GCP by those conducting clinical trials.

GCP guidelines are defined by the World Health Organization or WHO which sets standards and procedures for clinical trial management. The guidelines include the minimum expected standard on how clinical trials need to be designed, conducted. It also includes guidelines on clinical trial monitoring, performance recording, analysis, and reporting.

GCP guidelines define the roles and tasks of the institutional review boards, investigators, sponsors, and monitors. Guidelines on clinical site monitoring and clinical trial audit are also provided as part of GCP.

EMA is also responsible for maintaining the database of clinical trials that are conducted in the European Union.

Thus, the EMA is concerned with ensuring the credibility, reliability, and accuracy of clinical trial services by clinical research monitoring. The ultimate aim is to ensure the patient confidentiality and human rights are preserved.

Clinical Trial Regulatory process throughout EMA

Clinical Trial Regulation (EU no 536/2014) was adopted on 16^th April 2014 replacing the older 2001/20/EC directive. However, the application was made six months after confirmation of the EU portal and EU database’s full functionality. This document is the primary document that is referred to by clinical trial companies.

Objectives-CTR

The Clinical Trial Directive of 2001 was implemented through national laws. However, the Clinical Trial Regulation (CTR) was directly applicable.

The overall objective of the CTR was to make the European Union attractive for Research & Development.

The other objectives include: –

• To protect the human rights, safety, wellbeing, and dignity of the clinical trial participants.
• To ensure the credibility, reliability, and accuracy of the data generated and reported in clinical trials.
• To simplify the process of application to clinical trials by the clinical trial monitoring services.
• To encourage innovation and research.
• To increase transparency and responsibility in clinical trials.
• To keep the balance between protecting public health, stimulating innovation and research, and safeguarding the clinical trial sponsors’ economic interests.

Scope-CTR

The scope was confined to clinical trials of medicines intended for the use of human beings only.

• A new category of low-intervention clinical trials was introduced with an adaptation of some of the requirements.
• There can be an only minimal additional risk to patient safety compared to clinical medicine’s routine practice.
• The investigational medicinal products (IMP) are authorized and used only following terms of Medicines Agencies.
• If not, then use of these medicines should be supported by scientific publications.
• Non-interventional trials are out of the scope of the CTR.
• Also, clinical research monitoring trials that do not include medicines like surgery, devices, etc., are not included in the CTR scope.

New Processes-CTR

The CTR introduced several processes to make it easier for clinical trial companies and participants.

• Minimum standard of competence for GCP requires to be done through an e-submission link at the European Union portal, which is easily accessible to Ethics Committees and all member states concerned at one go.
• E-submission includes submission of all structured data and documents.
• A harmonized dossier for one trial was made to ease out the process.
• Increased cooperation and coordination were to be ensured between the reporting member state and the concerned member state.
• It also provides workspace with collaboration tools for coordinated assessment between member state concerned.
• Member state concerned can have only one decision.
• Distribution of the burden, among others, is ensured through this process.
• A risk-adapted approach was introduced for those trials where the medications are already authorized for use in practice. The use of this drug in clinical trial posed only minimally increased risk compared to the risk in routine clinical practice. It was achieved by introducing less stringent rules to these trials.
• New provisions were introduced in the process of consent taking.
• Union controls were reintroduced in member states to enforce supervision of clinical trials. It was done to ensure strict obedience to CTR, enforcement through supervision.
• Increasing transparency of clinical trials procedures and the data generated.
• They also introduced guidelines for those clinical trials that are conducted outside the EU with participants or are referred to a clinical trial application within the EU. In such cases, the clinical trial company will have to comply with regulatory requirements in sync with those defined for practice in the EU.
• Collaboration tools facilitate the joint assessment for Part 1.
• It also mentions that all clinical trial-related data will be reviewed and not in parts.
• Provides information that is open to the public.
• EudraVigilance clinical trial mode module was upgraded for electronic reporting of patient safety-related adverse reactions.
• It also requires and delivers a repository of Annual safety reports.

Transparency clauses-CTR

Article 81(4) of Regulation (EU) No. 536/2014 EU database is accessible to the open public with the following exceptions:-

• Personal data protection
• Confidential communication between a member state and the EU with relation to the assessment report
• Protection of confidential information relating to the medicines agencies status of medicines, unless disclosure is required to endure public interest
• To ensure effective clinical trial monitoring and supervision

Conclusion

          EMA guidelines for clinical trials are aimed at making the process streamlined, the agencies accountable, increasing coordination among member states concerned, and improving the transparency to all stakeholders. Increasing transparency develops confidence, stimulates concerted research, and empowers participants.

References

1. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials-human-medicines
2. https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
3. WHO handbook for good clinical research practice (GCP) – guidance for implementation.
4. REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL published in the official journal of the European Union.

The post What are the EMA Guidelines for Clinical Trial Management? appeared first on pepgra.

• Clinical Trial Management Systems (CTMS) are an essential part of every clinical trial. Choosing the right CTMS helps address inadequacies on the operational side of research, such as clinical trial preparation, planning, performance and writing for clinical trial monitoring.
• As more pharma and biopharma promoters start to identify the potential breaks with EDC-CTMS integration, there is a growing requirement to address the complicated electronic data capture (EDC) execution procedure.
• Pepgra explains the EDC benefits and implementation process in this blog and also offers clinical trial monitoring services

Introduction:

An Electronic Data Capture (EDC) framework is programming that stores persistent information gathered in clinical trials to lay it out plainly. Information is ordinarily first recorded on paper and is then translated into the framework and saved in an electronic case report format (CRF). An ever-increasing number of clinical trials are taking EDC programming and supplanting paper records with electronic records. Supporters, contract research organization (CROs), and locales have embraced EDC frameworks to do both straightforward and complex trials taking all things together periods of research. While there are numerous EDC merchants, a few associations assemble their framework in-house using clinical trial services. Most EDC frameworks offer somewhat various highlights, yet all EDC programming is intended to smooth out information assortment.

Uses of an EDC system in clinical trials

Many research associations understand EDC’s upsides over different techniques and utilize new medical monitor responsibilities in a clinical trial. An EDC framework can assist you with making progress in the accompanying manners:

Quicker Access to Data

An EDC framework can save a lot of time with continuous admittance to information and less time spent on inquiry the board. It additionally saves time toward the finish of an investigation, permitting faster accessibility of the data for examination. While it can require some investment to at first figure out how to utilize a particular framework, some are spontaneous to such an extent that a couple of long periods of preparing is required for clinical research monitoring.

Data Security 

An EDC framework is facilitated online with an information section finished on an electronic interface in the clinical trial audit. Given the idea of the information gathered in an EDC framework, programming sellers ensure the information is secured and sponsored up. Since every client account has assigned consents, most activities must be completed by specific jobs.

Accuracy

EDC frameworks improve information quality. There are choices to include limitations in a format that keep erroneous or strange rates from being entered. Utilizing a modernized framework empowers decipherable passages and programmed counts for cleaner information using clinical trial monitoring services.

Organization

The utilization of an EDC framework expands clinical trial management proficiency because of its easy to understand the route. Search choices permit you to discover and channel precisely what you need handily and store everything in one area with more prominent while utilizing less paper.

Cost-Effectiveness

Monetarily talking, the expense of an EDC framework goes from free to costly. Valuing shifts, and a few sellers charge for extra help and different costs. Buying an EDC framework can appear to be a huge venture. However, it should set aside cash over the long haul.

Compliance

An EDC should be consistent with administrative prerequisites. The product ought to have technical controls set up to guarantee information honesty. To appropriately keep an EDC framework, standard operation procedure (SOPs) are fundamental to ensuring administrative and hierarchical approaches are met.

Performing EDC in clinical trials

Making the transition to EDC

The appearance of EDC advancements is molding the clinical preliminaries information the executive’s scene, offering numerous advantages for the business. EDC’s appropriation instead of paper-based strategies was initially passive; anyway, clients can get things done with EDC that they can’t do with standard information bases, making a solid case for the venture. The most recent years have seen an extraordinary move in EDC’s take-up with paper CRFs currently just being considered for specific prerequisites.  Advanced layouts are handily changed to suit each new investigation; saving time spent planning and delivering paper CRFs. On average, it has been demonstrated that EDC cuts 41% of pre-study planning time. Utilizing EDC, information is gathered and gone into an information assortment device just a single time, with a paper framework; information should be entered first and foremost into a case report structure then into an electronic framework by an information section gathering. It expands handling time as well as influences record honesty.

EDC likewise permits information cleaning to happen promptly and doesn’t need escalated hands-on work from information the executive’s bunch for preparing. The info the executive’s bunch executes the rationale checks against data gathered weeks or months back as paper contemplates.  EDC framework rationale checks are conducted when the site enters and submits information, permitting it to be cleaned progressively.  At last, following appropriate framework determination and advancement, just as excellent examination the executives, EDC allows clients brisk admittance to clean information with low operational expenses.

Making a complete EDC data set plan

There is a requirement for interest as expected and assets to guarantee that every preliminary information base is exhaustive. If organizations don’t make this venture, there is a danger that changes, or increments, will be required later, which will be exorbitant and could have more extensive ramifications on tasks.

Most EDC frameworks accompany a standard set-up of reports; nonetheless, extra pieces might be needed for study oversight and the board. Most great EDC merchants can give additional custom announcing. Likewise, with the information base turn of events, the plan of reports must be very much thought of and indicated toward the start of the investigation.

Inside the plan of an EDC framework, it is likewise imperative to consider the configuration in which information is being gathered to be genuinely deciphered or customized in another outsider programming once it leaves the EDC framework. Executing a predictable information assortment strategy incorporates normalizing the definitions for the information gathered across numerous destinations.

EDC frameworks should have a choice to observe Clinical Data Interchange Standards Consortium (CDISC) principles, and for datasets to be following Clinical Data Acquisition Standards Harmonization (CDASH) rules, so it is prepared for factual examination later on. It can save time and efficiencies as non-CDASH information should be re-attempted to satisfy a CDISC guideline upon administrative accommodation.

The utilization of a more prominent number of standard plans during study constructs can assist with proficiency and the nature of revealing. Yet, it altogether lessens the time it takes for information bases to be assembled.

Conclusion:

As more pharma and biopharma promoters start to identify the potential breaks with EDC-CTMS integration, there is a growing requirement to address the complex electronic data capture (EDC) execution procedure and its applications. Pepgra explains the EDC benefits and implementation process in this blog and also offers clinical monitoring services.

References:

1. Sahoo, U., & Bhatt, A. (2004). Electronic data capture (EDC)–a new mantra for clinical trials. Quality Assurance, 10(3-4), 117-121.
2. El Emam, K., Jonker, E., Sampson, M., Krleža-Jerić, K., & Neisa, A. (2009). The use of electronic data capture tools in clinical trials: Web-survey of 259 Canadian trials. Journal of medical Internet research, 11(1), e8.

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