• 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.

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• 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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