MedicalResearch.com Interview with:
Lindor Qunaj BSc MD’19
Medical student, Warren Alpert Medical School of Brown University
Brown Center for Biomedical Informatics
Providence, Rhode Island
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Our study was motivated by growing concerns that incomplete or delayed release of clinical trial data may put patients at risk of harm or suboptimal treatment and slow the pace of biomedical innovation. Especially in a field as rapidly evolving as oncology, complete and timely dissemination of clinical trial results is critical to the advancement of both patient care and scientific discovery.
In an analysis of press releases from eight large pharmaceutical companies, we found that the median delay from presumed availability of Phase 3 trial data to peer-reviewed publication or public posting of results was 300 days. Studies reporting positive findings were published more rapidly than those with negative results.
MedicalResearch.com: What should readers take away from your report?
Response: Even among trials with the greatest potential to inform clinical guidelines and shape research agendas in oncology, delays in the release of meaningful data are significant. Industry sponsors, journals, and regulatory agencies need to work together to develop innovative and integrated solutions that facilitate rapid but thorough dissemination of study results. Policies that encourage prepublication or more strictly enforce public data posting on existing databases such as ClinicalTrials.gov are a start, but effective strategies will require buy-in from the various stakeholders involved in clinical research. Given the potential impact of current dissemination delays, these policy discussions should become a priority not only within the oncology community but throughout medicine.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Estimating the true impact that dissemination delays have on patient outcomes is a natural follow-up from our study. By focusing on specific cancer indications or classes of drugs with the same mechanism of action, you could theoretically calculate the number of patients managed with incomplete information and investigate the associated harms. Characterizing these effects is an admittedly challenging task, but would likely provide an even more compelling impetus for policy change.
No conflicts of interest to report.
Qunaj L, Jain RH, Atoria CL, Gennarelli RL, Miller JE, Bach PB. Delays in the Publication of Important Clinical Trial Findings in Oncology. JAMA Oncol. Published online April 12, 2018. doi:10.1001/jamaoncol.2018.0264
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