New rules on data sharing: how will they impact MPN trials?

May 17, 2017

ASH Clinical News ran an article last month about new rules from the NIH that dictated that outcomes from clinical trials operating with NIH funding must be shared within 12 months of the close of the trial. This is significant for clinicians who run trials, companies who provide drugs for trials, institutions that host trials and most importantly, patients who put their health and lives on the line when they participate.

MPNRF has long felt that whatever the outcome of a trial, the community is served by finding out what happened. We've seen trials come and go, always with reports of some patients experiencing benefit. While our focus is funding research that can effect patients' lives and change their prognosis, we also want to advocate for the release of information that could provide clues to what drugs work, in what patients, and why, in the event that another researcher or company may pick up the ball, even for failed trials. 

MPNRF has tried various means of accessing study results including asking companies directly and asking the FDA, both of which yielded no results. On the subject of data sharing we have required that grantees submit findings to dbGaP, which stands for database of Genotypes and Phenotypes. It was developed by the National Institutes of Health to archive and distribute the data and results from studies that have investigated the interaction of genotype and phenotype in humans. We've also structured research projects in such a way as to encourage collaboration between researchers at different institutions. We're trying to think big for the MPNs. 

What do you think? Will these new reporting guidelines help expedite more and better treatments for PV, ET and MF? What else would you like to see done?

Author: Woehrle, Michelle

Michelle Woehrle joined the MPN Research Foundation in 2007 after being inspired by their mission to fund research that will improve the lives of people living with the rare blood cancers PV, ET and MF. In 2015 she was promoted to Executive Director. She has assisted with the expansion of the grants program, grassroots initiatives to connect with more patients internationally and optimize operations for the Foundation.

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