Clinical Trials

Important information:

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, or for relieving symptoms of a disease. It refers to all research carried out on humans (healthy or sick people). It focuses on improving knowledge of diseases, developing diagnostic methods, and new treatments or medical devices to ensure better patient care. Clinical research is very much framed and respects a precise study protocol. It is only realized under certain strict conditions.
Clinical trials are the actual experimental studies in which human volunteers are included, after their consent, to test new treatments, instruments or tests.
There are two main types of clinical studies: interventional studies and observational studies.

Types of clinical trials:

• Pilot studies and feasibility studies.
• Prevention trials.
• Screening trials.
• Treatment trials.
• Multi-arm multi-stage (MAMS) trials.
• Cohort studies.
• Case control studies.
• Cross sectional studies.
At KEM, Diabetes Unit, therapeutic areas of clinical trials are T2DM, T1DM, Renal,CVOT etc.

Brief statistics:

Clinical trials are conducted in Diabetes unit since 1994. More than 50 clinical trials have been completed since then. More than 500 patients participated in different phases & types of clinical trials i.e. phase IIB, III, IV, PK-PD Studies, Observational studies.

To achieve optimal results:

• All team members are qualified & ICH-GCP trained.
• Local lab is NABH accredited.
• Site set-up is as per clinical trial requirement like Audio-Video consenting facility, examination room, calibrated equipment, emergency facility (well-equipped casualty, etc.)

Speciality at KEM Diabetes Unit Clinical Research:

• Scientific Concepts and Research Design encompasses knowledge of scientific concepts related to the design and analysis of clinical trials.
• Ethical and Participant Safety Considerationsincludes care of patients, aspects of human subject protection and safety in the conduct of a clinical trial.
• Medicines Development and Regulation ensures knowledge of how drugs, devices, and biologics are developed and regulated.
• Clinical Trial Operations (GCPs)oversees the study management and GCP compliance, safety management (adverse event identification and reporting, post market surveillance, and pharmacovigilance), and handling of investigational product.
• Study and Site Management is about the content required at the site level to run a study (financial and personnel aspects). It includes site and study operations (not encompassing regulatory/GCPs).
• Data Management and Informatics defines how data are to be acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database.
• Leadership and Professionalism describes the principles and practice of leadership and professionalism in clinical research.
• Communication and Teamwork sets all elements of communication within the site and between the site and sponsor, CRO and regulators, as well as the understanding of teamwork skills necessary for conducting a clinical trial.

Consultants / Staff involved

• Dr Chittaranjan Yajnik,
• Pallavi Yajnik
• Dr Smita Dhadge
• Dr NileemaThuse
• Rasika Ladkat
• Deepa Raut