ReviewClinical drug investigation2026
Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned Capacity-Building Workshop.
Review in Clinical drug investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.Biotech (Basel (Switzerland)) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors.
Funding
Abstract
A two-and-a-half-day workshop on regulatory and ethical issues in first-in-human (FIH) clinical trials in India was held at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, on 7-9 November 2024, under the aegis of the Indian Council of Medical Research (ICMR) Phase I Network. The workshop brought together regulators, academic investigators, and industry representatives to examine the evolving regulatory landscape of early phase trials in India and the operational challenges associated with it. Through interactive sessions, including preparation of investigational new drug (IND) application, mock pre-IND/IND and mock subject expert committee (SEC) meetings, on-site monitoring simulations, and structured hands-on exercises, the workshop navigated regulatory submission pathways, trial reporting, documentation standards, safety oversight, and informed consent processes. A panel discussion on the phase lag policy for FIH studies in India was held with expert personnel from regulatory agencies, ICMR headquarters, industry, and academia. The workshop discussions underscored the need for policy harmonization, enhanced site preparedness, and sustained capacity-building to position India as a leader for early phase clinical research. The present article summarizes the proceeding of the workshop and highlights the critical insights for developing a regulatory and ethical framework to support FIH trials in India.
Indexed as
Identifiers
42189405What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.