Clinical trials in India: There is a need for a separate clinical research audit body

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Pharmaceuticals: Clinical trials in India, the challenges

By Olinda Timms

There is a need for a separate clinical research audit body, along the lines of

a financial audit firm, which must be retained by the pharmaceutical company to

do a concurrent audit of the process and conduct of the clinical trial once it

is cleared by the IEC.

India has emerged as one of the preferred destinations for clinical trials of

drugs by multinational pharmaceutical companies in recent years. The reasons for

this include reasonably high standards of quality healthcare and healthcare

professionals, use of the English language and the sheer size of target

populations available in our country.

Although such trials must necessarily be multi-centric in nature to fully assess

efficacy, conduct of trials in North America, United Kingdom and many parts of

Europe turn out to be time-consuming and expensive.

With smaller populations that are more informed, people are less inclined to

participate in trials when they have alternative access to reasonable

healthcare. While clinical trials in the West are not totally free from

compromised interest, mishaps and litigation, the Medical Research Organisations

(MRO) are licensed and highly regulated and people are sufficiently aware of the

possible risks of such trials and also aware of their rights to healthcare.

In India, the scenario is very different. A non-uniform healthcare system, with

varying standards in the government and private sectors, desperate poverty and

lack of access to healthcare, illiteracy, lack of information and poor

enforcement constitute a chaotic milieu which is a major challenge for a

programme as critical as a clinical trial.

It is unfortunate that the international media has often reacted with unfair

outbursts, criticising the regulators, the government or the pharmaceutical

companies without a contextual understanding of the realities that exist here.

Since India stands to benefit from these trials by the much-needed investment

into healthcare and access to beneficial drugs, there is an urgent need to

create a conducive environment incorporating awareness in the general public and

the medical fraternity of the clinical standards and ethical practice essential

to the conduct of a clinical trial as well as strengthening of laws and systems

of accountability in this area.

In planning a trial in India one would also have to take into account the vast

cultural, economic, social and educational differences that exist. It is just

unrealistic for the pharmaceutical company to parachute the western model of a

trial into the complex situation that exists here.

In the absence of specific laws and general apathy in the enforcement of

guidelines and other laws that do exist, there is ample scope for exploitation

of our vulnerable populations by anyone with a vested interest.

Pharmaceutical companies are strongly averse to negative publicity as they have

their reputations, huge financial investments as well as years of painstaking

research at stake.

Importance of trials

Hence it would be disastrous for such companies if poorly managed, unmonitored

trials returned unreliable data based on which new health products are

introduced into the market. This is dangerous for the pharmaceutical companies

too, as it would harm its image internationally and may lead to crippling legal

suits.

In the current practice, the pharmaceutical company appoints the CRO to plan and

execute the clinical trial. The CRO will then identify the doctors, health

institutions and demographic of patients to be involved. The Institutional

Review Board (IRB) or Independent Ethics Committee (IEC) will study and approve

the trial plan at an early stage and is expected to review regular reports once

the trial is launched.

The pharmaceutical company cannot realistically monitor such trials.

Could the CRO be expected to audit itself as it is in its own interest to

complete the mandated trial? Hence, regulation and monitoring must be undertaken

by separate entities.

The Indian Council of Medical Research (ICMR), the regulatory body mandated by

the ministry of health, has done commendable work at a national level by drawing

up the Guidelines for Clinical Research †defining authorised institutions and

personnel who may be involved in clinical trials. The detailed guidelines seek

to ensure ethical practices and minimise exploitation of the participants.

With whom does the responsibility of monitoring these trials lie? The IEC or IRB

is expected to conduct regular reviews of the ongoing trial on the basis of

reports sent in by the Investigator. Field visits too would be part of this

review.

However, given the composition of the IRB/IEC, they could hardly be expected to

give much time to a detailed audit as the members are not full-time appointees.

They are occupied with regular jobs, and have only the submitted reports to go

by. This is clearly a weakness in the system.

There is a need for a separate clinical research audit body, along the lines of

a financial audit firm, which must be retained by the pharmaceutical company to

do a concurrent audit of the process and conduct of the clinical trial once it

is cleared by the IEC.

Like every new and emerging socio-commercial activity, conduct of clinical

trials is still evolving and will benefit from constructive input from the

government, healthcare institutions, medical professionals and civil society

organisations representing the public. Rather than blaming each other for

problems that prevail, these are the stakeholders who can positively impact

change in this field.

(The writer is a medical consultant and ethicist)

http://www.deccanherald.com/Content/May22009/panorama20090501133655.asp