Trusted Resource for Clinical Trials, Protocols & Progress
The CTRI was launched in July 2007 by the Indian Council of Medical Research (ICMR) through the National Institute of Medical Statistics (NIMS) with technical support from the WHO. It was designed to serve as a free, online, searchable database for all types of clinical studies conducted in India, including interventional, observational, and bioequivalence trials.
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Informed consent challenges in the digital era vary across populations:
Pediatrics: Dual consent from parents/guardians and age-appropriate assent tools are mandatory.
Rare Diseases: Patients often require additional education and support due to complex study designs.
Oncology: Patients under physical and emotional stress may need extra assistance understanding digital forms.
Advanced Therapies: ATMP trials require highly detailed consent forms explaining risks, manufacturing, and follow-up.
Sponsors should: (1) adopt the DIA TMF Reference Model; (2) validate eTMFs for Part 11 compliance; (3) establish SOPs for document management; (4) conduct periodic audits; (5) ensure contemporaneous filing; (6) monitor CRO TMF compliance; (7) maintain inspection readiness; (8) train TMF staff regularly; (9) implement version control and reconciliation processes; and (10) retain TMFs per regulatory requirements.
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Sponsors must pay extra attention when conducting trials in:
Rare diseases, where small batch supplies increase the risk of shortages.
Oncology, where comparators may be expensive and difficult to source.
Advanced therapies (ATMPs), where supply involves personalized manufacturing and just-in-time logistics.
Historically, clinical research in India was dominated by industry-sponsored trials. However, with growing policy support and capacity-building programs, academic institutions have emerged as key players. Recognizing their value, the NDCTR 2019 and CDSCO have provided simplified pathways for IITs while maintaining ethical and scientific rigor. The ICMR guidelines emphasize the responsibility of academic sites in protecting human subjects and maintaining data integrity.
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Transparency requirements may vary depending on the trial type:
Pediatric Trials: Plain-language summaries must be child-friendly and accessible to parents.
Rare Disease Trials: Data sharing is critical to enable global collaboration due to limited patient numbers.
Oncology Trials: High public interest requires timely and transparent dissemination of results.
Decentralized Trials: Additional transparency is needed for digital endpoints and eConsent processes.
Special populations such as pediatrics and geriatrics are rarely included in FIH trials. However, advanced therapies (ATMPs), gene therapies, and immuno-oncology products require additional safeguards, such as long-term follow-up and immunogenicity monitoring. Trials involving high-risk biologics often require staggered dosing and hospital-based monitoring facilities.
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Sponsors should: (1) validate biomarkers early; (2) engage FDA proactively; (3) adopt adaptive statistical designs; (4) harmonize global trial protocols; (5) ensure robust genomic screening partnerships; (6) maintain TMF documentation for all cohorts; (7) provide investigator training on eligibility criteria; (8) address diversity in recruitment; and (9) implement robust oversight of CROs and vendors.
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India’s clinical trial approvals are governed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. NDCTR 2019 replaces earlier provisions under Schedule Y, codifying responsibilities and timelines for trial initiation, ethics committee review, sponsor obligations, and safety reporting.
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Oncology: Dose-finding often uses Bayesian/adaptive methods with intensified safety oversight; ensure adolescent/young adult (AYA) pathways, fertility counselling, and cross-cover with adult services in tertiary centres.
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