A Clinical Trial Registry - India audit of listed head-and-neck cancer trials and studies from 2008-2022: A retrospective study

Abstract

ABSTRACT Background: Clinical trials are vital for advancing cancer treatment, but gaps exist in establishing ethical practices and transparency, especially in the context of head-and-neck cancers (HNCs) in India. Objectives: The primary objective of the study was to conduct a critical audit of the Clinical Trials Registry – India (CTRI) from 2008 to 2022; to quantify the number of studies and trials related to HNCs. Our secondary objective was to evaluate the credibility, accountability, and ethical advancements attributed to these registrations within India’s clinical research landscape. Materials and Methods: This was a retrospective study conducted between October 2022 and August 2023 at Homi Bhabha Cancer Hospital and Research Center, a tertiary cancer center in India. A thorough examination of the CTRI and PubMed databases was performed, encompassing 356 HNC trials registered at CTRI. Parallelly, 926 peer-reviewed publications from the leading clinical trial centers were assessed for credibility and accountability. Results: Of the 356 trials, 211 (59.3%) were interventional; however, 225 (63.2%) lacked explicit primary endpoints. Tata Memorial Center, Mumbai, India registered the maximum share with 98 (27.5%) trials registered during the period. Among the leading trial centers, notable discrepancy between CTRI registration and subsequent publication was observed, ranging from 2.2-8% across Tata Memorial Center (Mumbai), All India Institute of Medical Sciences (New Delhi), and Kasturba Medical College (Manipal). Conclusion: This audit exposed substantial ethical and transparency gaps, with a marked concentration in a few institutions within the Indian HNC clinical trials’ landscape. The study calls for urgent reforms to improve multi-institutional collaboration and ethical standards for enhanced human trials.