Table 1 Examples of various types of analyses performed with trial registry data, and a sample publication of each. The keywords linked to each publication are also listed
Category of information, and example with reference | Keywords |
|---|---|
1. Reporting quality A study of almost 800 trials showed that the methods were better reported in trial registry records than in the related publications [4] | Randomized trials; CONSORT statement; Bias; Research design; Prospective trials registration; ICMJE |
2. Research overview An analysis of almost 400 Expanded Access and Compassionate Use programs characterized the sponsors, enrollment eligibility, fraction of interventions that subsequently received approval by the US Food and Drug Administration approval, etc. [5] | Compassionate use, Expanded access, Experimental drugs, Access to medicines, Ethics, Bioethics, Policy, Right to Try Laws, 21st Century Cures Act, Pharmaceutical industry, Real-world evidence |
3. Research prioritization An analysis of over 3300 trials conducted in India demonstrated that there were areas in which trials have not been conducted [6]. Such analyses point to research gaps that need to be addressed | Clinical trials, disability‐adjusted life‐years, India |
4. Audit A study of almost 13,000 trials compared the number and nature of trials that were sponsored by each of the National Institutes of Health. This enabled each institute to assess how much of its own research had reached the stage of clinical trials, compared to that of other institutes. [7] | Clinical trials, ClinicalTrials.gov, National Institutes of Health, clinical trial funding, clinical trial registration, National Institutes of Health Institutes and Centers |
5. Assessment of bias There has been large-scale non-reporting of the results of trials, and various steps have been taken to rectify this situation, leading to positive change [8]. Not only does such non-reporting constitute research waste, but it could lead to a bias in the literature if positive outcomes are preferentially reported, and could also lead to a breakdown in trust between trial participants and the trial ecosystem, potentially damaging future participation | Clinical trials, Publications, Device approval, United States Food and Drug Administration |
6. Regulatory compliance One analysis of almost 3700 trials looked into whether trials have broken the law that required them to be registered in a particular registry [9] | Keywords submitted with the manuscript, though not available on the published paper: ClinicalTrials.gov; Clinical Trials Registry—India; hidden duplicates; duplicate registration; registry integrity; secondary ID; Clinical trial registry |
7. Research waste A study of over 2500 trials showed that over 480 of them were terminated (prematurely) or had enrolled an inadequate number of participants. [10]. There are economic implications if trials are terminated before completion. These costs are both directly related to the trial, and to the opportunity cost of not conducting other trials | Medical ethics, research ethics, clinical trials, trial accrual, recruitment |
8. Global trial landscape One analysis characterized over 6000 trials that ran in non-high-income countries [11]. The government of a developing nation may wish to know the nature of trials conducted in its territory in comparison to those conducted elsewhere | Clinical trials, Global health, Pharmaceutical companies |
9. Journalology Authors reporting on their work are often supposed to follow guidelines that the editors of major journals announce, or ratify. An analysis of over 16,600 trials demonstrated that journals may not enforce these guidelines effectively, leading to lower quality publications [12] | CONSORT, Endorsement, Reporting guideline, Completeness of reporting |