RECENT TRENDS IN CLINICAL RESEARCH" DR. CHANCHAL GOSWAMI"

The National Cancer Institute, Washington, as a footnote in every page of its clinical directives, mentions that the best way to treat a patient is through clinical trials. While this might sound as an exaggeration to some, it is a fact which India would possibly see more and more in the years to come.

Gone are those days when medicine used to be the prerogative of a handful of physicians treating patients on “Gut Feeling” and “Personal Experience”. With the advent of the internet and the expanded information technology, a need arose to shift the basis of medicine from personal experience to a more rational evidence based platform with the physician community speaking a common language worldwide and sharing information across the globe on a common format. Clinical trials are the most rational and scientific way to generate solid evidence on which the modern day medicine is based. The physician community in every discipline today speaks the common language of evidence based medicine, something which has arose in the last few years and probably is there to stay for a long, long time.

There are three levels of evidence on which any medical data or information is currently generated and based:

Level I
evidence: Evidence based from at least one properly designed, randomized, controlled clinical trial.

Level II
Evidence: Evidence designed from well designed controlled trials without randomization.

Level III
Evidence: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Of the above three levels, data generated by Level I evidence is the most rational and scientific way to treat patients. In certain rare situations where Level I evidence of a particular disease or treatment modality is not available, is one forced to resort to Level II or Level III evidence. Also Level II or Level III evidence is the data usually available for an upcoming or a new treatment modality for which as time passes by, if more and more Level I data can be generated, that treatment modality ultimately becomes the standard of care.

According to Mckinsey’s estimates, the total investment in India in Clinical Trials in 2007 would be about 200 million with a projection of about 1 billion by the year 2010.

There is an ever increasing interest and investment in the magnitude of clinical trials in India. Why is India becoming more and more popular among the Pharmaceutical Companies Worldwide as the preferred destination for clinical trials? The reasons could possibly be summed up as follows:

a. Huge population suffering from a vast number of diseases ,i.e. a high case load

b. ?? Less stringent rules and regulations

c. Reduced costs – about 60 – 70% cheaper to conduct a trial compared to
western countries.

d. About 200 – 250 investigators already well trained in Good Clinical Practice

e. More than 150 hospitals in India today have adequate infrastructure to conduct clinical trials.

f. Availability of English speaking, well trained manpower to conduct clinical
trials.

A couple of questions arise spontaneously in an inquisitive mind – Are we being treated as “Human Guineapigs” in the guise of these trials? Are we being subjected to a “Medical Colonialism” in the hands of few Pharmaceutical Companies with a lot of muscle to flex. The answer is probably not, if we are wise enough to choose the right kind of clinical trial, inform the patients and their relatives in detail about the trial, their rights, their expectations and their freedom to withdraw from any trial whenever they wanted to, so that patients are not taken for a ride. It is a responsibility which all the physicians should be aware of while undertaking a trial. As a physician, it is a social responsibility which we share and which we cannot ignore.

We, at B.P. Poddar Hospital, are involved in a number of clinical trials, mostly in clinical oncology. As a centre of excellence in undertaking clinical trials, we have till date conducted numerous Phase II and Phase III global as well as national multicentric clinical trials. To name a few, we have conducted 3 trials in Advanced Breast Cancer of which two are multicentric, multinational global trials and one was multicentric, national trial on the basis of which the new drug Nanoparticle Paclitaxel has been approved for licensing and marketing by Drug Controller General of India. We have also conducted clinical trials in Advanced Renal Cell Cancer as well as other indications like Advanced Small Cell Lung Cancer.

We have also conducted clinical trials on supportive therapy for cancer treatment, viz. New antiemetic drug for prevention of cancer chemotherapy induced nausea and vomiting and on the results of the trial, the new drug Palonosetron has been approved for licensing and marketing by the Drug Controller General of India.

We have also conducted clinical trials in preventing cancer chemotherapy induced anemia and have been subjected to Co – Monitoring and Audit by U.S., F.D.A. which was the first of its kind for any centre in India, conducting clinical research in Oncology.

Apart from this, there are other ensuing trials in various other indications like Non – Small Cell Lung Cancer, Ovarian Cancer, Head and Neck Cancer, Pancreatic Cancer as well as other specialities like Pulmonology and Orthopaedics, mostly dealing in Chronic Obstructive Pulmonary Disorders and Osteoporosis.

While we are being offered a large number of clinical trials, we are very specific in choosing only those trials which are not purely experimental and in which a substantial amount of data is already present so as to safeguard the interests of our patients.

One of the advantages of clinical trials is that it gives the patient a chance to undergo treatment, the cost of which hitherto probably would have been prohibitive. While the patient being treated under a clinical trial is actually undergoing an effective treatment, it also generates valuable data which serves as a basis for future treatment and research. Clinical trials lay the foundation stone for future treatment strategies.