By invitation. Why a clinical trial may be what the doctor ordered

The benefits of participating in a clinical trial are many, yet patients are hesitant to sign up for one primarily because they are misinformed or are unaware of the real implications and don’t know what to expect.

In my experience as a clinical research practitioner, I have found that patients are more inclined to participate in a trial once they are educated on what it involves, the safeguards in place, and most importantly how participating in such a programme has the potential to benefit people.

The foremost advantage of participating in a clinical trial is getting access to a drug or treatment which is not yet available in the market and is more cutting-edge than available therapies. Therefore, for patients who have stopped responding to existing therapies, a clinical trial is the only chance at getting a new drug, which could improve their quality of life.

In addition, for drugs already tested and approved for larger (Phase 2 and 3) clinical trials in other countries and then brought to India to undergo Phase 2 and Phase 3 trials, the risk factor is lower, as the adverse effect profile is better known to the investigating physicians.

India has the highest chronic disease burden in the world. Treatment of diseases like cancer, diabetes, and asthma spans decades, posing a huge financial burden for patients. From that perspective, patients can benefit by volunteering for a clinical trial as the treatment is free of cost. The entire cost is borne by the study sponsor (usually, the pharmaceutical company that owns the drug) including the treatment of any any side-effects.

Furthermore, patients are reimbursed for their travel to and from the clinical research facility and compensated for the wages lost because of the time spent away from work.

Compared to the standard of care, clinical trials entail a higher level of monitoring by the investigating team. There are stringent mechanisms in place to monitor any adverse drug reaction and as a result of that, adherence to treatment in a clinical trial is also much higher compared to standard medical treatment.

It is very common for patients to miss a drug dose every now and then, and some patients, who are put on a longer treatment course spanning several months, stop taking the drug on their own prior to the completion of treatment once they observe some improvement in their symptoms. In a clinical trial, drug intake is tracked closely; the treatment adherence rate is 100 per cent.

Less than 1.4 per cent of all global clinical trials are done in India and one of the key factors contributing to this statistic is the challenge investigators face in recruiting patients for studies. Typically, investigators talk to some 20 patients before getting one to sign up for the study.

It is important that patients are fully aware of their rights and understand what the clinical research process entails, so they are able to make a well-informed decision. A wide pool of informed patients who are aware of their rights as trial participants is the key to increasing participation in testing programmes across various therapies and treatment modalities. An increase in India's contribution to global clinical trials can improve treatment options available to our patients.

The writer is a Physician Scientist who has for 10 years been doing Respiratory Research at the Chest Research Foundation, Pune, where she heads the clinical trials division. The views are personal.

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