With the support of the Department of Pharmaceuticals, Govt of India, a five-day workshop on 'Clinical Trial Protocol Writing' has started at the National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar on August 24. Dr Vasanta Muthuswamy, former senior deputy director general, Indian Council of Medical Research (ICMR), New Delhi inaugurated the workshop.
Dr Muthuswamy, former, senior deputy director general, Indian Council of Medical Research (ICMR), New Delhi said that Clinical research has become a huge business enterprise all over the world especially in India. It is predicted that India will be a global hub and comfort for the clinical trials all over the world. She added that there is a huge requirement of clinical resource personnel in the country. This gives the opportunity to the various institutes, schools to come up with weekly, monthly, quarterly, half-yearly, yearly certificate course to train the manpower in the field of clinical trials.
Talking about clinical trial protocol writing, Dr Muthuswamy said that, if the protocol is not written in a proper way, the entire data is of no use and will not be accepted for further use. Hence, it is necessary that the clinical trial investigator should write a good protocol with authentic information for the further acceptance of clinical trial conducted. Talking about the training components, she said that the quality of syllabus and teaching needs improvement in the area of Clinical trial protocol writing training. She appreciated NIPER's initiative in this regard which is playing an important role in this training segment.
Professor P Ramarao, director, said, "Fundamentally we all know that any new chemical entity is being tested before in human beings, we have to conduct the pre-clinical pharmacology and then the approval process needs to be done. Over the last few years, numbers of new chemical entities for drugs approved by United States Food and Drug Administration (FDA) has declined, even though the budgets have been increased."
Prof Ramarao explained, "For example, last year the US FDA has approved only 19 molecules, which is the lowest in the last 24 years. US $47 billion worth of drugs are going off patent by year 2010, which would create great opportunities for the generic drugs requirement to introduce in the market for which clinical trials for bioequivalence needs to be done. In the phase of downturn, every one wants to cut down the cost factors of drug discovery and development and switch over to outsourcing of the discovery and development part from all over the world. In this particular case, in the year 2007 US $44 billion outsourcing activities appeared which is expected to increase by US $76 billion by next year. He said that four years back there were only 100 clinical trials as per available data of year 2005 and when we talk about May 2009, as per CTRI, 895 clinical trails has been registered in CTRI maintained by Ministry of Health & Family Welfare, Govt. of India."
He appealed to the participants that this workshop would give an excellent opportunity to come together and exchange ideas with reference to the clinical trial protocol writing. The presence of distinguished expert speakers from the clinical industry, medical institutions and regulatory body would sure, help the participants to understand the finer issues on clinical trial protocol writing, he added.
Around 100 participants, which include CRAs & investigators working in the field who are looking for the additional training; professionals from pharma industry/ academia are expected to attend the programme.
The focus area of the workshop is to provide advancement in knowledge and skills of persons working or intending to work in clinical research. This workshop will be of special use to professionals and students associated with pharmaceutical & biotechnology industry, academic institutions, regulatory agencies, clinical research organizations and healthcare Industry. The workshop will comprise of lectures to be delivered by distinguished personalities drawn from industry, regulatory bodies and the academia. The five-day workshop will have a comprehensive coverage on Clinical Trial Protocol Writing. Topics like basics of medical writing; writing SOPs; understanding of research designs; designing a study protocol; clinical trial protocol writing and clinical research report writing will be covered by the experts during the workshop.