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RESEARCH

Provision of state-of-art and affordable cancer treatment can only be made possible through the installation and fortification of an in-house research facility which would ensure breakthroughs in cancer care and help guarantee best cancer treatment for each and everyone’s need. Clinical trials are an integral part of bringing about cutting-edge and indigenous technology in cancer care. This would help make the cancer treatments accessible and affordable for the increasing cancer patients in India. Clinical trials although voluntary, involve actual humans and their health is at stake. NCI has thus initiated and formed an Ethics Committee (NCIEC) with an objective to provide a quality and consistent ethical review of clinical trial and all types of research proposals in humans.

Clinical Trials

A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments.

Clinical trials are done to determine whether new drugs or treatments are safe and effective. These trials are part of a long, careful process which may take many years to complete. First, doctors study a new treatment in the lab. Then they often study the treatment in animals. If a new treatment shows promise, doctors then test the treatment in people via a clinical trial.

NCI is a registered world class cancer care institute based on strong moral grounds. NCI is equipped with all the necessary infrastructure and facilities to conduct all phases of Clinical Trials. Trials are conducted as per ICMR, Schedule Y & ICH-GCP Guidelines issued by the Central Drug Standard Control Organization, Ministry of Health and Family Welfare, Government of India. Accordingly, we have registered Institutional Ethics Committee.

Phases of Clinical Trials:

When clinical research is used to evaluate medications and devices. Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.

Phase I trials: Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.

Phase II trials: The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III trials: The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV trials: Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

National Cancer Institute Ethics Committee (NCIEC)

National cancer institute ethics committee (NCIEC) is an Institutional Ethics Committee established with an objective to provide a quality and consistent ethical review of clinical trial and all types of research proposals in humans. This committee complies with the ethical guidelines for biomedical research on human beings laid down by ICMR guidelines, ICH-GCP guidelines, Schedule Y & guidelines issued by the Central Drug Standard Control Organization, Ministry of Health and Family Welfare, Government of India.

The NCI Ethics Committee should safeguard the rights, safety and well-being of all trial participants. As cancer patients are often vulnerable and concerned, special attention should be paid to the trials that include these participants. The NCI Ethics Committee is responsible for providing public assurance of that assurance, by reviewing and approving/providing opinion on, the trial protocols, the suitability of the investigators, facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial participants.

Objectives of IEC

  • To protect the dignity, rights and well-being of the potential research participants with emphasis on human rights.
  • To complement existing law, regulation and practices
  • To provide service as a basis following which ethics committee can develop their standard operating procedure.
  • To ensure that universal ethical values and international scientific
  • Standards are expressed in terms of local community values and customs
  • To assist in the development and education of a research community responsive to local health care requirements.

Role of IEC

  • IEC - will review and approve all types of research proposals involving human participants with a view to safeguard the dignity, rights, safety and well-being of all actual and potential research participants. The goals of research, however important, should never be permitted to override the health and well-being of the research subjects.
  • The IEC will take care that all the cardinal principles of research ethics viz. Autonomy, Beneficence, Non-beneficence and Justice are taken care of in planning, conduct and reporting of the proposed research. For this purpose, it will look into the aspects of informed consent process, risk benefit ratio, distribution of burden and benefit and provisions for appropriate compensations wherever required. It will review the proposals before start of the study as well as monitor the research throughout the study until and after completion of the study through appropriate well documented procedures for example annual reports, final reports and site visits etc. The committee will also examine compliance with all regulatory requirements, applicable guidelines and laws.
  • The mandate of the IEC s will review all research projects involving human subjects to be conducted at the NCI, irrespective of the funding agency.

Members:

Education

NCI strives to provide specialized Quaternary Cancer Care Treatment and for that it needs a specialized, trained resource pool of doctors and nursing staff to realize this on ground. NCI has thus currently introduced short-term diploma courses for nurses and doctors and fellowships to provide quality education and trainings for providing the best cancer care.

Fellowships

The fellowship courses are conducted at NCI in affiliation with the Maharashtra University of Health Sciences (MUHS), Nashik for a period of one year and in the following Subjects:

  • Head-Neck Surgery
  • Cytopathology
  • CT & MRI of chest & abdomen
  • Medical Oncology
  • Onco Anaesthesia Critical Care and Pain Management
  • Onco Pathology
  • Infection prevention and control with specific reference to Hospital Acquired infections
  • Advanced Nursing Care in Oncology

ACCREDITATION UNDER DIPLOMATE OF NATIONAL BOARD DrNB

Accurate selection of treatment that will be the most effective is the key to successful cancer treatment today. Cancer treatments are rapidly evolving and becoming increasingly complex with the advancement of technology in healthcare. On ground experience in super-speciality fields helps upgrade the knowledge and skills of the medical graduates in the field of oncology. Thus, NCI has on priority applied and has received accreditation through DNB.

National Cancer Institute received accreditation on July 2021 for starting DNB program in the department of Surgical Oncology, for a period of 5 years. The seats allotted in the speciality of Surgical oncology is 2. Accreditation is awaited for DrNB for Medical Oncology.

CMEs for Doctors and Nurses

India has an estimate of one trained oncologist for every 2000 cancer patients. The number of cancer patients are increasing every year and NCI conducts CMEs periodically in order to update the knowledge of the doctors and nursing fraternity for them to deal with the cancer patients in an informed manner.