Reporting Clinical Trial Results Needs to Be More Timely, Neurologists Say

Researchers across the globe are evaluating a growing number of potential therapies for ALS in the clinic. But according to a new analysis, the findings of many of these clinical trials are not reported, making it more challenging to efficiently develop more effective treatments for the disease.

A publication delay? The results of clinical trials are published more than 2 years after completion according to a new study.[Courtesy of Sreekrishnan et al., 2018. JAMA Neurology.]

The analysis, led by neurologist Kevin Sheth at Yale University School of Medicine in New Haven, Connecticut, found that researchers published the results of only about 1 out of 2 clinical trials [54%; 154 out of 285] registered on clinicaltrials.gov for neuromuscular diseases. And, these reports appeared on the pages of research journals more than 2 years after trial completion.

What’s more, less than 40% of these research teams [38.6%; 110 out of 285] uploaded the results of these clinical trials to the website clinicaltrials.gov.

The findings build on previous studies, which found that the results of more than 40% of clinical trials conducted [43.5%; 1889 out of 4347] that are registered on clinicaltrials.gov remain unpublished (Chen et al., 2016).

The study appeared on April 30 in JAMA Neurology.

Featured Paper

Sreekrishnan A, Mampre D, Ormseth C, Miyares L, Leasure A, Ross JS, Sheth KN. Publication and Dissemination of Results in Clinical Trials of Neurology. JAMA Neuro. 2018 Apr 30.

References

Chen R, Desai NR, Ross JS, et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ. 2016; 352:i637. [PubMed].

Further Reading

Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in clinicaltrials.gov—the final rule. N Engl J Med. 2016;375(20):1998-2004. [PubMed].

Ross JS, Mocanu M, Lampropulos JF, Tse T, Krumholz HM. Time to publication among completed clinical trials. JAMA Intern Med. 2013;173(9): 825-828. [PubMed].

Additional Resources

Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Database. The results of 23 phase 2 and phase 3 clinical trials are available. Apply for access.

clinical trial clinicaltrials.gov disease-als final rule topic-clinical transparency
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