What Ails Clinical Research in India?

chillibreeze writer — Usha Kamat Sharma

Clinical Research became a highly desirable bandwagon around 2005, when all was well with the economy around the world, and when some starry-eyed estimates pegged the future value of research projects in India at astronomical, and perhaps unrealistic, levels.

An unholy frenzy to climb on to this golden dream led to a clinical research boom which now threatens to go bust, leaving many dreamers holding the proverbial bag.

So what is going wrong? Does anything ail the sector?

When a noise is sufficiently loud, it naturally attracts attention – from the wary, the curious, the ignorant and the bold. Noise about clinical research opportunities offered by India woke up China, Malaysia, Australia and other players with similar attributes, and suddenly the pie was divided into many more segments than originally visualized.

With so much competition, Indian clinical researchers need to take stock of what interests the global clientele, and what may frighten them about India.

Clinical trials emerged from the dark shadows of World War II and the infamous US Tuskegee study with a commitment from the medical profession to always uphold the interests of the patient, above all commercial and scientific considerations of profit, fame, glory and so on.

The Helsinki Declaration of the World Medical Association is reviewed regularly to adapt to changing modalities of research and evolving medical needs. And yet, the term “clinical trials” conjures up a picture of torturous experimentation, which is in reality extremely closely observed and regulated by designated authorities worldwide, precisely in order to remove this aura. The spirit of the Helsinki Declaration is embodied into regulations governing and guiding the conduct of clinical trials, and has yielded a best practice guideline called Good Clinical Practice or GCP guideline.

GCP specifies the desirable process of conducting clinical trials, spelling out in great detail the steps to ensure ethical conduct and safeguard the interests of the patient or volunteer participating in the trial.

Now comes the worrisome part about trials in India.

Ethical issues in clinical trials in India are expected to be addressed through the appointment of an Ethics Committee or EC (called Institutional Review Board, IRB in other countries), which approves the protocol (plan) of the study, oversees the obtaining and recording of informed consent from trial participants, the actual conduct of the study, and the reporting of adverse events arising in the course of the trial.

The constitution of an Ethics Committee in an institution is seen as an assurance that all is well with the clinical trial process in that institution. Patient safety continues to direct the decisions pertinent to trials, and the quality of data generation needs to rationalize the means employed.

However, in reality, ECs work very differently and rarely follow the GCP guidelines. The following was observed in a teaching medical institution:
The members themselves did not meet the requirements in terms of experience or familiarity with the clinical trial process. The agenda was not circulated in advance to members. The honorary secretary was almost always too busy to circulate the minutes, which were noted by hand in a ledger book, and which were not signed on the spot by members present.

Meetings were scheduled at maximum permissible intervals and few members had scientific observations or queries to be resolved, as they had no desire to offend the investigators, who were seen as bringing research grants to the institution.

With such ECs in teaching institutes, what can be expected in terms of protection of patients’ rights?

The Human Rights Protection Bill 2005 was scheduled to be tabled in Parliament in January 2008, but there is no news of its fate as yet.

Worse yet, there is no awareness of these transgressions, or even an acknowledgement that they ARE transgressions. There is no interest in their impact either. Just a complacent smugness about clinical research opportunities, almost like they are simply commercial ventures on the lines of call centers.

Apart from the Ethics Committees, another important mechanism overseeing the GCP guideline compliance is the process of clinical trials auditing. This process is considered mandatory in the EU and the law has been changed recently to ensure that this is effectively accomplished. The USFDA too considers auditing mandatory.

Sadly, the Indian Drug Law merely mentions that an audit certificate should be included in a new drug dossier “if available”.

What then can possibly motivate a manufacturer to commission an audit (a source of added costs) of his products or services?

Unfortunately, for the most part in India, quality is only perceived in a very narrow sense as the quality of a manufactured item. The other crucial area of application, to a company’s services, are not considered worthy of quality checks or audits.

Clinical research, sadly, is one such neglected service within a pharmaceutical company. The quality of clinical research is a mission that is individually driven by the ethos and values in a given company, and sometimes only by the personal vision of the in-house scientists.

A recent article in a popular pharmaceutical business journal states, “Clinical trials auditing in India is a pressing need of the day and must be undertaken to ensure that the rights, safety and well-being of human subjects participating in the trial are protected and the reported trial data are accurate and complete. This would give a sufficient guarantee that the report of the clinical trial is credible and worthy of submission to the drug regulatory or licensing authority and publication in a medical journal”(1)

It is a sad commentary on the status of clinical trials in India today that the need for clinical trial auditing has to be emphasized to ensure the upholding of ethical values, scientific integrity or sheer credibility, for fear of taking a back seat in this bumpy ride to a global marketplace.

An old adage urges, “Physician, heal thyself”. Who should we urge now, for healing this ailment? Should we now call out, “Physician-Researcher, heal AND audit thyself” before it is too late to save clinical research in India?

For a start, he following simple processes can be adopted to make some form of headway into solving the problem.

1. Short term measures:
a. Heightened awareness through training and communication, of the imperative to measure, monitor, and thereby assess and improve the quality of clinical research at every level; sponsor, monitor, regulator, inspector, investigator, clinical coordinator etc.
b. More proactive interest in quality of clinical trials from the regulatory viewpoint, but unaccompanied by bureaucratic delays.
c. More critical assessment of manuscripts by medical editors for compliance with available guidelines such as the CONSORT Guidelines for publishing randomized clinical trials’ reports.
d. Registration of all trials in the Registry.
e. Greater involvement of Independent Ethics Committees unshackled by institutional hierarchical pressures.

2. Long term measures
a. Providing formal training for quality auditors and inspectors to evaluate quality in research.
b. Providing training to investigators in research method
c. If necessary, curriculum changes at post graduate level
d. Amendments in Drug Laws to make GCP assessments mandatory in the dossiers compiled for New Drug Approvals

Is this just one more Utopian vision?
To quote the lyrics for a well known stage version of Don Quixote,
“To dream the impossible dream,
To fight the unbeatable foe,
To bear with the unbearable sorrow,
To go where the brave dare not go.
To fight the unrightable wrong,
To love, pure and chaste, from afar,
To try when your arms are weary,
To reach the unreachable star,
This is my quest”……. (From the Stage adaptation of Miguel de Cervantes’s “DON QUIXOTE”)
Come, together let us make Quality in Clinical Research a reachable star.

Chillibreeze's disclaimer: The views and opinions expressed in this article are those of the author(s) and do not reflect the views of Chillibreeze as a company. Chillibreeze has a strict anti-plagiarism policy. Please contact us to report any copyright issues related to this article.

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—About our writer:

Dr. Mrs. Usha Kamat Sharma, Clinical Pharmacologist and Pharmaceutical Physician, with over 30 years experience as a Medical Director, has now “superspecialised” into Process improvement (Six Sigma) of Clinical Trials, GCP audits, Quality Management (ISO 9001:2008),and Food Safety (ISO 22000:2005) audits. Loves teaching, reading, writing, painting and sketching, photography, crochet, cooking and traveling. Wildlife and nature enthusiast, she has adopted six dogs, now utterly spoiled by her and her family.

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