Pharmaceutical research and development in India is coming of age. In some instances, these efforts have led to commercialisation of innovative medical products to address healthcare gaps in areas of unmet medical needs. Clinical development has also resulted in improvement in R&D standards in India.

Drug development activity has also generated a lot of debate and raised doubts about adequacy of protection of patients participating in trials. Media coverage on trial deaths at AIIMS raised a number of questions around patient exploitation, safety and perceived individual/systemic lapses. The report by AIIMS clarified most if not all these issues in this specific case. This instance however does lead one to question the accuracy of media coverage of the growing industry that often borders around sensationalism. There is a need to clarify fundamental tenets of clinical research, offer an analysis of clinical trial injuries and discuss key issues raised in the debate.

A clinical trial is typically initiated after ascertaining unmet medical need and ensuring that a clinical study is considered essential by professional standards. No clinical trial can commence if any of the stakeholders (regulators, investigators or ethics committee) believe that either investigational or standard therapy are distinctly different in terms of risk-benefit.

Against this backdrop, a subject participating in a clinical trial can develop injury during or after the course of trial participation. This injury may be because of ?

• Underlying disease (eg retinopathy ? the injury in this case results from progression of patient?s underlying condition eg diabetes.)

• Drug therapy (eg fall in blood counts in patients taking chemotherapy for treating cancer) ? in this case the drug therapy is implicated as a cause of injury/side effects.

• Patient factors (eg wrong frequency, missed doses, wrong technique ? an error on patient?s part in taking medicines.)

• Physician factors (eg incomplete or wrong information on the part of a physician.)

A study drug implicated as a cause, injury helps to the understanding about its safety profile. This is not alarming, as possible side effects as well as the procedures for management of/compensation for clinical research injuries are always discussed upfront before the start of a study to ensure prompt and timely clinical care and compensation.

Most of the discussion around clinical trials erroneously presumes industry as the sponsor. Incidentally, the term ?Sponsor? does not necessarily mean an industry sponsor ? this term also includes academic sponsors, medical universities, and governmental agencies as they initiate a study concept. This is an important distinction to understand.

Industry sponsored global trials are always considered as the culprit in clinical trial injury because of an inadequate understanding about trial methodology, systems available for protecting human subjects and roles of various stakeholders. This ignorance can be dispelled through clarifying misperceptions on these issues.

• Clinical research is not just clinical trials with drugs, it also includes epidemiological and observational studies and outcomes research.

• Clinical research is not conducted just by pharmaceutical companies; it may sponsored by government, medical universities, individual doctors and international agencies.

• Clinical research is conducted when considered essential to answer a scientific question after approval from ethics committees and regulatory authorities.

• There is a system of patient protection in clinical research involving multiple stakeholders.

• National and international regulations and guidelines place a premium on patient safety.

• Patient safety assessment continues throughout the course of the study and even after its completion.

• Regulators review compliance with regulations and assess risk-benefit.

Over the last decade, foundations of conducting clinical research and ensuring patient safety have now been put in place. A trial injury or death does not always mean that the system is not working.

All stakeholders need to work together to dispel wrong notions, develop greater research capacity, adopt benchmarks and enforce greater vigilance. Indian Society for Clinical Research (ISCR) can partner with regulatory agencies and ethics committees for developing policy, implementing certifications/ accreditations to ensure minimum standards, provide independent oversight/quality assurance to strengthen overall systems for clinical research implementation. The society intends to partner with media to raise awareness about this discipline. All concerned should not lose sight of the purpose involved in drug development to advance medical science and find solutions for unmet medical needs of our fellow human beings.

The writer is a Council Member of the ISCR and Director, Medical & Research division, Pfizer Ltd