Overcoming the challenges of clinical trials in India
June 03, 2013: India is one of the current hot spots for conducting clinical trials, as it offers a plethora of positives ranging from a diverse gene pool, to advanced study facilities, and a lower cost of investigational studies.
The process of clinical trials is not only a daunting task for researchers and investigators, but also for the subjects recruited in the study. Often always, the inclusion criteria for a trial are so specific and rigid, that although a huge patient pool exists, the subjects qualifying for the study are just a fraction of the available pie. Once these teething hurdles are dealt with, comes the challenge of retaining patients and minimizing drop outs. This could be achieved by explaining and highlighting the study to the patient, taking them through the possible effects of the new drug, and signs and symptoms they would be expected to watch out.
Following up with the participants, sharing the overall information and results from a study, and crediting them for their contribution towards the evaluation will make them view the study more critically and diminish the chances of drop outs.
Informed consent is a criterion that cannot be stressed upon enough. Federal regulations and IRB protocols require that the patient is kept in the know of the medical treatment being meted out to him, in a manner which is not overwhelming. This could be achieved by pictorial or graphical representations which are not more than 2 pages, summarizing the study, such that no crucial pieces of information are withheld or lost.
Clinical trial design and implementation in India are carefully being structured these days with a lot of attention and importance being given to patient education, comfort and understanding. Since successful and effective communication with volunteers is key, regularly sharing the generated data and their role in obtaining it, and ensuring that the trial is conducted in a well set-up center with consistent care has so far proved to be successful steps when it comes to trials in India.
Dr. Jay Shinde