What are the EMA Guidelines for Clinical Trial Management?

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WHAT ARE THE EMA GUIDELINES FOR CLINICAL TRIAL
MANAGEMENT
An Academic presentation by Dr. Nancy Agnes,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email pepgrahealthcare_at_gmai
l.com
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Today's Discussion
OUTLINE In-Brief Introduction Clinical Trial
Regulatory process throughout EMA Conclusion
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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.

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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.
Contd...
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GCP guidelines are defined by the World Health Org
anization 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 clinica
l trial monitoring, performance recording,
analysis, and reporting. GCP guidelines define th
e roles and tasks of the institutional review boar
ds, investigators, sponsors, and monitors.
Contd...
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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 i
s concerned with ensuring the credibility, reliabi
lity, and accuracy of clinical trial services by
clinical research monitoring. The ultimate aim
is to ensure the patient confidentiality and
human rights are preserved.
Contd...
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Clinical Trial Regulatory process throughout
EMA
Clinical Trial Regulation (EU no 536/2014) was
adopted on 16th 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. Contd...
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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, w
ellbeing, and dignity of the clinical trial
participants.
Contd...
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To ensure the credibility, reliability, and accura
cy of the data generated and reported in
clinical trials. To simplify the process of appli
cation 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.
Contd...
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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.
Contd...
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If not, then use of these medicines should be
supported by scientific publications. Non-interve
ntional 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 seve
ral processes to make it easier for clinical trial
companies and participants.
Contd...
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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.
Contd...
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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.
Contd...
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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.
Contd...
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In such cases, the clinical trial company will hav
e 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.
Contd...
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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.
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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.
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