Copyright © 2021 pepgra. All rights reserved 1

What are the EMA Guidelines for Clinical Trial Management

Dr. Nancy Agnes, Head,

Technical Operations, Pepgra

Sales.cro@pepgra.com

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.

Copyright © 2021 pepgra. All rights reserved 2

II. 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.

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.

Copyright © 2021 pepgra. All rights reserved 2

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.