Clinical translation of neuro-regenerative medicine in India: A study on barriers and enabling strategies

摘要

We present the findings of a study of barriers and enabling strategies to clinical translation of Neuro-Regenerative Medicine (Neuro-RM) technologies in India. Twenty-three people were included in this qualitative study, including researchers, clinicians, firm representatives and policy makers working in Neuro-RM. The study has identified barriers that may arise at each stage of translation and how these are being addressed. Understanding of the molecular and cellular basis of Neuro-RM is being supported through government investment in existing neuroscience centres and the creation of new centres with regenerative medicine expertise. Clinical trials benefit from the support of clinicians who partner with researchers in study design and data collection. Government agencies have developed guidelines to inform best practices in preclinical and clinical studies. Addressing the barriers to Neuro-RM translation identified in this study can be achieved through continued support for capacity building and priority setting in preclinical studies, international efforts to achieve clinical trial protocol standardization, and multidisciplinary collaborations between clinicians, researchers, government and industry.