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THE PHARMA REVIEW (MAY 2009)

Clinical Trials - Protecting Patient’s Rights And Safety  While Meeting the Need for New Drugs

Dr. M.D. Nair

Introduction: The Indian Pharmaceutical industry has been rightly recognised as one of the leaders in the supply of generic bulk drugs and formulations for the global markets. The Country has over 75 U.S. FDA approved plants, the largest number outside the U.S. and around 30% of all Abbreviated New Drug Applications (ANDAs) for generic drug approvals by the U.S. FDA are from Indian Companies. India has become an outsourcing destination for pharmaceutical production by Companies in U.S. and Europe. More and more Pharmaceutical R&D efforts are being contracted out to India , a reflection of the skills, productivity, capability and cost effectiveness of Indian research groups compared to those abroad. It is therefore natural that Companies are looking out to India for conducting Clinical trials on new drugs under development. In this area too, India offers major advantages. They include the availability and accessibility of large number and variety of patient population, outstanding clinical facilities, skilled western-trained clinicians, adequate infrastructure and good communication systems.
 
To fully understand the finer nuances of this very important activity, it is essential to take stock of global developments in this vital area and its role in the improvement of healthcare through interventions with new drugs

 
Issues Related To New Drug Discovery Research
New drugs, ever since the advent of chemotherapy, have been discovered from two major sources, synthetic chemicals and natural products including plants, animals and microbes. For proof of efficacy and safety animal models have been resorted to in what is termed pre-clinical screening. The methods include random screening against such models of disease as well as more rational approaches to identify potential drugs. Serendipity both at the pre-clinical stage as well as clinical stage has also played a major role in many drug discoveries. During the last two decades the new field of use of recombinant DNA technology has also made a foray in new drug discovery. Whatever be the approach to drug discovery, it is obvious that clinical trials (human) is the ultimate litmus test for utility of a candidate drug in patients.
 
Estimates of the relative costs of the many components of the drug discovery and development vary a great deal. Of the estimated total R&D costs for a new drug of $ 1 billion, the costs of three phases of clinical trials as per U.S. costs constitute around 35% ie, $ 350 million of which multi-centric open, comparative and double blind trials alone cost around $ 175 million. These costs are steadily on the increase in the developed markets of U.S.A, Western Europe and Japan. In 2008, against a global R&D spending of over $ 60 billion, only 21 new drugs were approved by USFDA. It is clear that such low success rates make pharmaceutical R&D one of the most non-productive activities of Pharmaceutical industry. Declining pipelines and failures both during the development phase and even post-marketing has made the drug discovery process unaffordable even for large pharmaceutical companies. The strategies of global mergers and acquisitions and recourse to newer approaches including use of more rational drug discovery tools such as genomics and proteomics are yet to yield tangible results. 

 

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