CROs: Beneficial to Indian patients

In order to reap financial benefits, India’s nascent clinical development industry must maintain the highest ethical, clinical and quality standards, says Dr Nermeen Y Varawalla

The recent spate of media articles expressing concern for the safety and rights of clinical trial participants is both, commendable and important. However, news articles have tended to gloss over the undisputed fact that the most important beneficiaries of a thriving Indian clinical research sector will be Indian patients. Participation in ICH (International Conference of Harmonisation) GCP (Good Clinical Practice) compliant international clinical trials will deliver valuable direct and indirect benefits to Indian patients.

The direct benefits of participating in clinical trials are access to better and subsidised clinical care. Medical literature is filled with numerous examples of clinical trial patients enjoying better health outcomes when compared to their counterparts who are not enrolled in one. This is the case in both, the placebo and treatments arms of the trial. Improved health outcomes are most marked in cancer patients, with patients participating in oncology clinical trials achieving improved quantitative and qualitative outcomes as compared to patients with equivalent types and grades of cancer who are not enrolled in clinical trials.

The primary reason for this is that clinical trial patients receive more attention from medical, nursing and administrative staff. This increased attention results in not only better management of their disease but also boosts their morale, causing improved outcomes. Furthermore, patients who are fortunate to receive cutting edge, innovative therapies that are effective in curing or controlling their disease enjoy the ultimate benefit of a longer and healthier life.

In addition to the above direct benefits, the entire Indian patient population will benefit from a mature clinical research industry. Clinical investigators and their clinician colleagues will get exposed to the discipline and rigour of international clinical research. This will help develop an appreciation of the importance of meticulous clinical practice, uncompromising data collection and scrupulous medical record keeping. Also, Indian physicians will become more adept at evaluating the true efficacy of treatments using stringent outcome measures. These skills will make better doctors and improve clinical care standards with positive long term impact on patient care in India.

In accordance with ICH GCP guidelines, patients are never paid for participating in clinical trials but almost always receive the study drug free of charge. As costs of medication, investigations and hospitalisation in India are a fraction of that in North America or Western Europe and the incentive of subsidised treatment does speed up patient recruitment, study sponsors can often be persuaded to subsidise all or part of the participant’s treatment costs.

In addition to direct subsidies, a part of the investigator and trial site fees will be utilised for the purchase of equipment, employment of additional staff and/or contributions towards individual treatment expenses. These additional resources and facilities will benefit not only clinical trial participants but also the entire patient population that attends hospitals which participate in clinical trials.

With globalisation, the distinction between developed and developing world diseases is fast disappearing. Apart from a group of tropical diseases such as malaria, visceral leishmaniasis and leprosy, there are few diseases that are exclusive to the developing world. Indeed, India has some of the largest patient populations with cancer, heart disease, diabetes, lipid disorders and obesity, diseases that have traditionally been considered to be ’developed world’ diseases. Therefore, concerns that Indian patients would be used to develop drugs of little value to India are misplaced.

Furthermore, a well developed Indian clinical research sector would be able to efficiently develop new drugs for tropical diseases with benefits not just for India but also for disease populations in Africa and Latin America. phase I clinical trials account for a very small portion of clinical drug development in terms of subject numbers, duration of projects and revenues. However these trials are of great scientific importance as they represent first ever administration of the study drug in man. Thus, phase I trial data is critical for new drug development and the capability to conduct Phase I trials with world class safety and quality standards is an indicator of a well developed clinical development industry.

Hence, phase I capabilities will help attract the larger late phase global clinical trials. For these reasons it is important for the Indian clinical development industry that phase I capabilities are developed in select facilities and as with every phase of clinical development adherence to the highest GCP standards is mandatory. In order to deliver the benefits to Indian patients and reap financial rewards, India’s nascent clinical development industry must maintain the highest ethical, clinical and quality standards. Most industry players understand this and are committed to doing so.

The role of the government and regulatory bodies is to help the industry achieve these standards so that it may thrive and deliver value to its many stakeholders. Recognition of common objectives should enable co-operation and constructive dialogue between the government, DCGI (Drugs Controller General of India), pharmaceutical companies, CROs (Contract Research Organisations) and academic clinical departments. Such a dialogue will positively contribute to the growth of India’s clinical development industry with much benefit to all stakeholders, most importantly our patients.

The writer is Managing Director, PerinClinical (www.perinclinical.co.uk)
E-mail: nermeen.varawalla@perinclinical.co.uk