ROLE OF REGULATORY Anish Ghale

AUTHORITIES IN Ankita Ojha

CLINICAL TRIALS Nischal Joshi

 INTRODUCTION
 Drug regulatory Authorities are the bodies that aim to establish proper safety and
efficacy profile of pharmaceutical interventions before being launched into the market.
By the definition it is pretty evident that DRA have a major say not only in the products
that are already being launched into the market but the interventions which are currently
being trialed for their safety and efficacy.
The interventions which are aimed by the sponsors to be launched into the market have
to undergo rigorous assessments and evaluations during the clinical trial.
Clinical trial should be conducted in a framework that’s designed to safeguard the well-
being of trial subjects as well as ensure the credibility of clinical trial data.
Regulatory Authority has to ensure the trials are being conducted in such a manner and
follow established norms set in,
Declaration of Helsinki GCP (WHO, ICH or other) Local rules and regulations
 ROLES OF REGULATORY
AUTHORITIES IN CLINICAL TRIALS
1. Granting the clinical trial license based upon the
 Pre-clinical studies
 Protocol Assessment with regards to risk-benefit of investigational product

2. Pharmacovigilance (Safety Report Analysis)

3. Inspection

4. Evaluation of results
HOW DOES FDA ENSURE RELIABILITY
OF CLINICAL TRIAL DATA?
From the Office of inspector General reports, 78 % of all subjects were enrolled outside
the U.S.

Even in such cases, FDA is successfully

able to monitor the studies and ensure the
reliability and validity of studies being
conducted alongside the results generated.
 FDA Accepts Foreign Clinical data from studies if the following conditions are met:
I. Study was conducted in accordance with Good Clinical Practice (GCP)
II. FDA is able to validate the data from the study through an onsite inspection

 Sponsor shall submit to FDA a description of actions taken to ensure research

conformed to GCP:
o Defined as a standard for the design, conduct, performance, monitoring, auditing,
recording, analysis, and reporting of clinical trials in a way that provides assurance that the
data &reported results are credible and accurate and that the rights, safety, and well-being
of trial subjects are protected

Next aspect is the onsite inspections, which help to ensure the protection of rights,
safety and welfare of research participants, to ensure data that are submitted in
marketing applications are fit for purpose for regulatory decision making (Approval) and
allow evaluation of compliance with FDA regulations
ROLE OF THE DRUG REGULATORY AUTHORITY
AS PER THE GUIDELINES FOR GOOD CLINICAL
PRACTICE (GCP) FOR TRIALS ON
PHARMACEUTICAL PRODUCTS, WHO
General Responsibilities

The national drug regulatory authority should ensure that the protocols for clinical trials are
submitted in advance for review and are in accordance with existing national regulations. On
the basis of its review of clinical trial protocols and/or reports, the regulatory authority may
propose revisions or request additional data on a clinical trial or terminate a trial.

The drug regulatory authority should evaluate the adequacy of supervision of the trial by
reviewing the monitor’s reports to the sponsor.

National regulations should specify the procedures for reporting and handling cases of
misconduct discovered in connection with clinical trials.
On-site Inspections

 Inspections may be carried out routinely, randomly and/or for specific reasons, and
should consist of a comparison of the procedures and practices of the investigator with
those set out in the protocol and reports submitted to the drug regulatory authority by the
investigator or the sponsor.

The inspection should determine whether the investigator has custody of the required
records or, if not, who has assumed this responsibility. The data archives should be tested
for ease of retrieval.

Inspections may include data audit. The drug regulatory authority should have easy
access to all patient files and raw data used for and generated during the trial.