Education and Training

Major role in education and training in area of cancer as no formal medical curriculum covers this specialty

Hold regular workshop on clinical research Methodology certificate course – covering subjects -

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 MVR Cancer Centre & Research institute are bestowed with the widest range of patients in large numbers and finest laboratory support. A unique centre ' Clinical Research Department ' (CRD) was commissioned in 2019 to temper the vast data generated from clinics/laboratory and draw meaningful conclusions with clinical endpoints.

The CRD 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. CRD has supported over 15 retrospective studies, 16 prospective studies from clinic and lab, 3 randomized clinical trials. Majority of the studies have been either presented or published in peer reviewed journals and various national and international conferences.

An international centre for clinical trials has been established At MVR Cancer Centre & Research Institute 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 community initiatives are a norm, would benefit from having a centralized facility to conduct trials involving thousands of subjects. The randomized clinical trial offers a unique opportunity to test these issues scientifically before they are sanctioned for routine health care.

The IEC is established to formalize and specify Institution's commitment to the promotion of high scientific and ethical standards in patient care, professional education, clinical research, and community interests. Timely review and the safeguarding of high ethical standards formed the basis of the IEC review process. These are essential for clinical research including student research, investigator initiated research, extramural, intramural funded research and multi-centric multinational research. Institutional Review Boards (IRBs) became functional in February 2018. Institutional Ethics Committee (IEC III) was established in September 2019.The Institutional Ethics Committees (IEC) are constituted by the Secretary, CARE foundation under authority vested by the Executive Board, CARE Foundation.

DCGI Registration under Rule 122DD of the Drugs & Cosmetic Rules 1945. IEC Reg No:

Mandate

The IEC through its delegated sub-committees functions independently for maintaining a consistent scientific and ethical framework for patient care and research, and for integrating ethical values into practice, policy relationships, and organizational activities. The purpose of the IEC is to cultivate a pluralistic and democratic exchange of scientific and ethical values and concerns, and to critically analyze them while looking for opportunities to enhance the scientific and ethical integrity of Institution. The mandate of the IEC essentially is to promote patient care through a scientific and ethical approach to research and education.

The terms of reference for the IEC are as follows

The IEC endeavors to provide guidance on a broad range of topics such as disclosures of diagnosis, diagnosis of brain death, indications for stopping resuscitation, true informed consent, etc. The committee does not address or interfere in matters of administration, nor does the committee function as a grievance cell for staff members.

Meeting Schedule: Once in every 3 months

Composition

IEC will be multidisciplinary and multi-sectorial in composition. Each IEC is composed of a minimum of 7, and maximum of 12- 15 members. The members are selected so as to have an equitable representation of all specialties in MVRCCRI. It includes scientific and non-scientific members, clinicians and non - clinicians, a clinical pharmacologist, members of the community, a lawyer-expert in ethics, a social worker / layperson / patient representative to represent different points of view. Each committee will comprise of a Chairperson, Co-Chairperson, a Member Secretary, and 4-12 other active members who represent an appropriate balance of professional, ethical, legal, cultural, educational, and community interests. The committee should have adequate representation of age, gender, community, etc. to safeguard the interests and welfare of all sections of the community / society. Members are expected to be aware of local, social and cultural norms, as this is the most important social control mechanism. The members should have various backgrounds to promote complete and adequate review of research activities commonly conducted by MVRCCRI.