The clinical trial rules are changing, and the question is, how will researchers, laboratories and drug companies meet the requirements? Beginning January 18, 2017, researchers will need to meet tighter parameters regarding the reporting of clinical trials data according to new policies and regulations released by the National Institutes of Health and U.S. Health and Human Services.
CHANGES IN REPORTING
The NIH policies require trial researchers to submit summary results to ClinicalTrials.gov for all clinical research supported by the agency, including early phase I safety trials and behavioral research. In tandem with that policy, the HHS ruling requires all trial sponsors regulated by the Food and Drug Administration to send in their results within one year after the trial’s conclusion. This applies to approved products—but now also to phase II and III trials for drugs and devices not yet approved or that won’t ever make it to the market.
Trial results aren’t the only thing that must be reported, either. With the new ruling, trial sponsors now need to submit their protocol and original statistical analysis plan, along with the summary results. The intent is clear here—to share information about trials that failed, and to avoid any manipulation of data for better results.
COMPREHENSIVE APPROACH NEEDED
With these new rulings, the need for efficient, comprehensive tools for Clinical Trials Operations (CLINOPS) has never been greater. Whether a sponsor is working with one lab or several Contract Research Organizations (CROs), it is more imperative than ever to ensure all trial data is properly monitored, that the trial drug and other supplies are distributed correctly, that all regulatory requirements are being met, and that the trial data is compiled and analyzed accurately.
While the recent rulings may be new, Sampleminded’s comprehensive CLINOPS solutions have been around for years. For more than a decade, Sampleminded’s experts have been working closely with NIH and other research labs around the world to design and implement software management systems that empower researchers to effectively track, and execute.
We know that what works for a small single center trial does not work for a complex study with dozens of assays being run at labs spread across the country (or world). Sampleminded’s team of accomplished molecular biologists, engineers, researchers, and bioinformatics leaders understand the complexities of clinical trials. We work hand-in-hand with sponsors and labs to customize systems that help researchers meet ever-changing regulatory demands like the recent NIH and HHS policies.
Whether researchers create in-house management systems or partner with industry leaders like Sampleminded, 2017 is a year that will usher in even more need for vigilance in trial execution and reporting as domestic organizations pursue greater breakthroughs for patient care.
For more information visit www.sampleminded.com.