EMA Guidelines for Clinical Trial Management - Pepgra Healthcare

The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. EMA guidelines for clinical trial regulations adopted in 2014 aim to make it easier for the clinical trials companies while empowering participants through transparency.

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What are the EMA Guidelines for Clinical Trial Management


Dr. Nancy Agnes, Head,
Technical Operations, Pepgra
[email protected]




In-Brief

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.

Keywords
clinical trial monitoring, clinical trial
services, clinical research monitoring,
clinical site monitoring, clinical trial
audit, clinical trial monitoring services,
clinical trial management, clinical trial
companies.

I. INTRODUCTION

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.

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II. 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.

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 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
III. 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/eu
dralex/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.