Ethics of sponsored research.

The combined effort of private sponsors and academic researchers will undoubtedly bring in the forms of clinical trials is expected to usher in tremendous progress in science. Unfortunately, if not monitored, such trials can deviate from the humanitarian goals. Hence, registration in a common platform of such trials is mandatory and monitoring of such platforms is also necessary. Furthermore, caution should be exercised at all levels during the conduct of a trial.

“There is no medicine like hope, no incentive so great and no tonic so powerful as expectations of something better than tomorrow.”

INTRODUCTION

A clinical trial can be sponsored by either a commercial group/organization or an institute. The past few years has seen a tremendous rise in researchers being funded by private industry. This is a symbiotic relationship where both parties stand to benefit. The researcher receives resources and funds necessary to conduct the research while the company gains from the expertise of the researcher staff and laboratory space to conduct its research. Such ideal setting can be fruitful in terms of progress in the field of research.[12]

Commercial sponsors lack an access to patients/human subjects and heavily depend on academic researchers for clinical trials. This mutualism is effective as they can provide financial resources/supply of their product namely-drug/vaccine/any other to be tested by academic researchers who interact with these patients at academic tertiary care facilities. This relationship has two sides, one that it offers tremendous promise in terms of accelerated research that will benefit patients sooner by making development of newer drugs/newer approaches to therapy e.g. anti-cancer drugs while on the other side, unfortunately there are ethical problems. There are many complexities involved in such partnerships which mandate regulatory and stringent operative management systems. The stakes involved are many and this “virtual-more than real” conflict between profit and humanitarian perspectives warrants careful handling of each and every aspect of such a partnership.[345]

“Well-designed, well-run clinical trials are the only way to determine the true effectiveness of a promising new agent or intervention being investigated” - cancer clinical trials: The In-Depth Program, National Cancer Institute.

The Indian Council of Medical Research has made it mandatory to register all trials through its portal on the Clinical Trials Registry India (CTRI). This is also a mandatory prerequisite for any publication that would arise out of the trials. During the registration, the approval of the local ethics body such as the institute ethics committees (IEC) and the DCGI is essential. International multi-centric trials, where India is a participating country need to be registered in the CTRI even though they may have been registered in an international registry. In the CTRI, details of investigators, date of enrolment, sponsors, interventions, patient population etc., are collected and all the trials registered will be monitored to ensure increasing disclosure of all items. Once a trial is registered, regular updating of the progress of the trial or other aspects by the investigators need to be made and all updates and changes will be recorded and available for public display.[67]

There are a however a few issues which need to be addressed and there is still ample space for improvement.[178910]

The consent of the subjects/patients: Recently a number of irregularities in the conduct of clinical trials in India have been noted mostly related to dubious consent taking procedures[1] and allegations of drug trials on the poor

Declaration of conflict of interest-this is a very important aspect and thrust to be laid on expressing it rather than declaring it as “Nil”. The CTRI aims at improving transparency and accountability by disclosing all required details of the protocol of trials

Number of trials under an investigator: The number of clinical trials/sponsored trials with an investigator at a time should be restricted as the focus of the investigator will be scattered and instead of investing critical time onto a project, hardly any time is spent on the same

If PI is a member of the IEC: The principal investigator who happens to be a member of the IEC or is one of the signatories for the IEC can have an influence on the committee decision making capacity hence, either the I IEC needs to be reframed or the PI should cease to be a member of the IEC

Role of the IEC: The IEC has a very important role to play in the governance of a clinical trial. The trials should be cleared by the IEC so as to be registered with the CTRI and hence, the IEC should be updated and have all the necessary information required by the CTRI from the investigator. The CTRI aims at improving the trials and allows the investigators to publish their work

Reporting of all results of registered trials: The investigators are bound ethically to divulge all results of the trial. The CTRI is working with the World Health Organization to ensure that results of all trials registered with the CTRI are adequately reported and publicly available. Furthermore, stringent measures should be placed to measure the outcome hence that unlawful activities are not allowed to percolate into any trial. One of the best-known and most often discussed cases that raise questions on biomedical ethics with translational research is that of Dr. Nancy Olivieri and Apotex, Inc., a major Canadian manufacturer of generic drugs. This case exposed how an industry-healthcare partnership can become mal-functional if terms and conditions are not abided by and crucial information is not reported.[9]

Hence, it is important that one remembers that complete transparency should be a part of all research and not just clinical/sponsored research. Any scientific research should be abided by the doctrines of the ethical principles-respect for fellow beings, justice and beneficence.

“The truth is like a lion. You don't have to defend it. Let it loose. It will defend itself.”

Research is like re-telling the truth. Research in the field of medicine has a bright future globally. The scenario has changed drastically over the last decade and holds a lot of promise in India. Nevertheless, caution should be exercised at all levels during the conduct of a trial.