Clinical Trials Overview

Principles

Definition

Clinical trials is a systematic research methodology conducted in human participants to evaluate the safety and efficacy of new medical interventions, such as drugs, devices, or procedures. This rigorous process investigates whether experimental treatments are beneficial and safe for use, serving as a critical stage in advancing medical knowledge and improving patient care.

Ontological type

Trial Phases

Study Design Methods

Ethical Considerations

Key developments

Key Figures

Interim and Adaptive Designs era

Edward M. Sellers[1], with affiliations at Harvard University[2] and Boston University[3] during this era, became a central figure in interim and adaptive trial methodology. His 1981 paper, A method for estimating the probability of adverse drug reactions[4], offered a formal approach to safety monitoring that supported early decision-making while preserving inferential validity. Edward M. Sellers[1] helped integrate adverse-event risk estimation into group-sequential thinking, providing a mechanism to quantify harm probabilities that underpinned ethical minimization of exposure. Edward M. Sellers[1] contributed to the era by aligning adverse-event risk estimation with stopping rules and adaptive design principles, demonstrating why interim monitoring was essential for flexible, ethically responsible trials.

Reporting and Protocol Standardization era

David Moher [1] is a leading figure in the Reporting and Protocol Standardization era, with affiliations at Stanford University [3] and Johns Hopkins University [4]. His key contributions in this era include the CONSORT statement [7] for improving the quality of reports of parallel-group randomised trials and the template for intervention description and replication, the TIDieR checklist [6], which reduced bias and improved reproducibility. Douglas G. Altman [2] is a leading figure associated with the Institute of Cancer Research [5] and Stanford University [3] during this era. Altman's contributions to this era include promoting rigorous reporting standards through the CONSORT statement [7] and the TIDieR checklist [6], institutionalizing reporting norms and enabling cross-study synthesis and credibility of trial-derived evidence.

Platform Trials and Integration era

David Moher [1], with affiliations at Stanford University [3] and the University of Maryland, Baltimore [4] during this era, stands as a leading figure in evidence synthesis methodology. His key contribution in this era is the PRISMA 2020 statement [7], an updated guideline for reporting systematic reviews, which enhances transparency and reproducibility across platform trials and real-world evidence syntheses. James Thomas [2], with affiliations at Northwestern University [5] and University College London [6] during this era, is a pivotal figure in evidence synthesis and reporting standards. His work on the PRISMA 2020 statement [7] and related guidelines helped standardize systematic review reporting, supporting rigorous integration of multi-source evidence and accelerating learning in platform trials.