The harvest of science should reach bedside. The most important source of the harvest is clinic with support from lab and final weeding process by statistical methods. We, at the Tata Memorial Hospital are bestowed with the widest range of patients in large numbers and finest laboratory support. A unique centre ' Clinical Research Secretariat ' was commissioned in 1997 to temper the vast data generated from clinics/laboratory and draw meaningful conclusions with clinical endpoints.
The CRS offered a wide range of services from collection, maintenance, quality control & analysis of data to design & execution of prospective trials of importance to the institute and nation. The primary aim was to generate easily testable hypothesis from focused retrospective analysis or laboratory studies. To test novel avenues with survival or quality of life end points in observational studies or randomized trials. To support mega-trials from multiple centres spread all over India. To rethink on more technology in patient care and challenging dogma with appropriate clinical studies. To collate published evidence by Meta-analysis to define the state of art treatment.
CRS has supported over 50 retrospective studies, 18 prospective studies from clinic and lab, 25 randomized clinical trials and 10 meta-analyses. Majority of the studies have been either presented or published in peer reviewed journals.
A national centre for clinical trials has been established At Tata Memorial Hospital not only to initiate clinicians in the concept of scientific and evidence-based medicine but also to address burning medical and epidemiological questions in which the west is unlikely to have any interest. Scientific leads from laboratory ultimately need to be answered in human subjects in the form of a randomized clinical trial. But, due to a lack of understanding as to how such a question should be addressed in a clinical setting and a lack of interaction between the clinician and the laboratory scientist, many important scientific leads are lost by default. The scientific community, other funding agencies and ultimately patients may benefit from testing the efficacy of newly synthesized biological products such as engineered enzymes, genetic materials and other substances emanating from laboratories. In the sphere of public health, where very large trials are a norm, the ICMR as well as NPC would benefit from having a centralized facility to conduct trials involving thousands of subjects. The testing of a new vaccine for common diseases such as cervical cancer (caused by the human papilloma virus) is one such example. Other examples could include whether many of the commonly used indigenous herbal products are truly beneficial or even superior to conventional allopathic remedies. Recent research in India in animal systems suggests that 'haldi' or its active ingredient curcumin helps to prevent oral cancer. This, however, has not been confirmed in humans in the absence of a large well-conducted randomized clinical trial. For the Ministry of Health, the assessment of efficacy and cost-effectiveness of new and expensive drugs or technologies imported from the west for general use in our country with limited health care resources is essential. The randomized clinical trial offers a unique opportunity to test these issues scientifically before they are sanctioned for routine health care.
Clinical research in cancer is one of the avowed objectives of Tata Memorial Centre and DAE funded cancer centres (DAEFCC). Numerous clinical research projects including several randomized clinical trials are currently in progress. The Institutes have a well established Scientific Review Committee and Ethics Committee. The projects will be approved by the Ethics Committee, which comprises of members from a wide spectrum of society to include not only oncologists and medical doctors but also special scientists, philosopher and lay individuals. It is only when ethics approval is obtained that a project will be allowed to be undertaken by the investigator. In addition to national funding bodies, the TMC & DAEFCC has received funding from several international funding agencies for clinical research projects. The TMC is currently conducting two of the largest randomized trials in the field of early detection and prevention of cancer ever conducted in any field of cancer. The National Cancer Institute, USA is funding one of these trials through a competitive RO-1 grant and the other by Melinda and Bill Gates Foundation through the International Agency for Research in Cancer, Lyon. In addition, TMC is involved in conducting numerous trials on behalf of national multi-national industrial concerns, health agencies (DST, DBT, ICMR) TMC has a centralized clinical research secretariat with facilities for data collection, data management and analysis. All clinical research at the centre is coordinated from here and this secretariat forms the central hub for all research activities at TMC.
Although service to patients remains the central activity, every clinician at TMC is expected to undertake clinical, laboratory or public health research in cancer. A large number of oncologists are already well trained in the area of clinical research providing a large pool of existing expertise. On the basis of their research contribution, several of the staff members are on the editorial boards of national and international journals in the field of cancer, on advisory boards of national and international bodies and have been visiting professors to national and international institutions.
Education and Training will form an important activity of the DAECTC. The current medical curriculum does not offer any training in clinical research either at the undergraduate or at the postgraduate level. In order to fill this void, DAECTC could play a major role in education and training in the area of cancer.
Regular workshops on clinical research methodology will be held to give intensive training in good clinical practice, principals of randomized clinical trials, case-control and cohort studies, data accrual and management, quality of control of data, statistical methodology etc. The participants will also be given hands-on training in the use of software packages for data collection, data management and statistical analysis.
Research fellowships would be offered which would enable young oncologists from other centres to come and train at this centre. This will help to create a pool of trained clinical scientists in the country capable of conducting independent clinical research and undertake clinical trials, which could be utilized for the conduct of national multicenter trials.
The DAECTC will form the nodal point for the co-ordination of randomized clinical trials and other clinical research activities in cancer in the country. A Core Group consisting of well known academic oncologists representing 8-10 centres of excellence will institute identify important research projects, direct and co-ordinate the research activities of DAECTC.
A centralized laboratory is essential for undertaking standardized assays in any multi-centre research programme. With the laboratory facilities that would be available at ACTREC it will be possible to carry out sophisticated laboratory tests, which form part of clinical research projects. These include hormone assays, receptors assays, enzyme assays, specific genetic markers etc.
DAECTC would play an important role by offering advice on design, protocol writing, sample size, designing case record forms etc. for other centres, which lack the necessary expertise.
The DAECTC would from time to time hold national and international conferences to promote clinical research activities in the country. The first meeting on practice of evidence based medicine and formulating guidelines for uniformity of standards of care across the country was held on 28 February and 1-2 March at the Tata Memorial Hospital.
SOP for Clinical Research Secretariat ( Pdf Format)