Public Disclosure of Clinical Research Is an Important Factor for Evidence-Based Decision-Making: Is the Current Evidence Being Disclosed in a Timely Manner?
Jadhav V1, Dsouza I2, Ogata H2, Bhole VM2
1Bioviser Inc., Mumbai, MH, India, 2Bioviser Inc., Boston, MA, USA
OBJECTIVES: According to World Health Organization, the main findings of clinical trials should be submitted for publication, preferably open access, in a peer-reviewed journal within 12 months of study completion. The Food and Drug Administration Amendments Act mandates reporting summary results in the database of ClinicalTrials.gov within 12 months of study completion. We therefore assessed the proportion of completed trials on psoriasis that have publicly disclosed the primary results within 2 years of primary completion date, either as a publication or on ClinicalTrials.gov.
METHODS: We recorded the “primary completion date” of psoriasis phase 1-3 clinical trials completed in 2000-2020. We also recorded the “first posted results date” on ClinicalTrials.gov and the “first primary online publication date” from literature search, and earlier of these two dates was identified as the “results revealed date.” Next, the difference in “primary completion date” and “results revealed date” was calculated.
RESULTS: Of 706 completed clinical trials, only 67.6% had revealed the results (44.8% first presented as journal publications and 22.8% reported on ClinicalTrials.gov). Among 477 studies that revealed the results, mean (SD) time to first public disclosure of primary results was 31.5 (25.1) months (41.8 [31.3] for ClinicalTrials.gov and 26.2 [16.6] for scientific publications). The results of 6.5%, 29.9%, and 31.2% trials were revealed in ≤1 year, 1-≤2 years, and >2 years, respectively. Recent studies were disclosed more often (~70%) vs those starting before 2006 (47%).
CONCLUSIONS: Compliance to public disclosure of clinical trial results is poor but improving with time. However, low compliance to CONSORT guidelines between 2000 and 2010 may have impacted our results. Prompt public disclosure of clinical trial results can provide real-time clinical trials data to physicians and help them make evidence-based, informed decisions, thus paving the way for real-world outcomes research and eventually improving the quality of healthcare and patient outcomes.
CONFERENCE/VALUE IN HEALTH INFO
2023-05, ISPOR 2023, Boston, MA, USA
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Methodological & Statistical Research, Organizational Practices, Study Approaches
Clinical Trials, Industry, Missing Data
SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)
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