Establishing a biomedical and health research unit in hospital setting: Overcoming barriers to translational research in India - A case study.

Current amended New Drugs Clinical Trials 2019 rules have simplified and streamlined regulatory processes that allow investigators to conduct investigator-initiated studies without central licensing authority approval unless directed by the Ethics Committee. Regulatory delays, funding constraints, and lack of collaboration still hinder investigator-initiated clinical trials (IICTs) to improve patient outcomes and healthcare practices. IICTs are important for addressing local health issues which are beyond the scope of pharma-sponsored research. In this paper, we outline a step-by-step approach for establishing a dedicated Biomedical and Health Research Unit (BHRU) even in resource-limited environments (financial and infrastructural limitations) that provides the necessary support to investigators, covering every aspect from research design to publication. The paper describes the practical approach of developing team comprising lead researchers, core medical writers, and trained statisticians. BHRU conducted research activities while ensuring investigators were relieved of administrative burdens. To enhance research proposal submissions, we developed a comprehensive database of investigators, research areas, and funding agencies. The development of a comprehensive publication database not only facilitated the archival of our publications but also helped to track manuscript submissions to journals. Published papers influenced changes in clinical practice in our hospital. To ensure required patient enrolment, BHRU implemented proactive recruitment strategies, such as an in-house patient database, and prescreening logs. To equip investigators with essential skills for conceptualizing protocols and adopting appropriate research methodologies, we established in-house training programs and external workshops. To reduce administrative and operational challenges in collaborations, BHRU acted as a centralized point of contact. Understanding that most of the government funding agencies requirement, we planned and acquired Scientific and Industrial Research Organization accreditation.