Client: DiaTech Holdings/Pierian Biosciences, Inc.
Date: September 21, 2016
Project: PR – Op-Ed: Response to New Clinical Trials Requirements from HHS
Cancer deaths have declined substantially in the past decade. According to the National Cancer Institute, from 2003 to 2012, cancer deaths rates decreased by 1.8 percent per year among men, 1.4 percent per year among women, and 2.0 percent per year among children. While these are certainly promising developments, cancer isn’t going away any time soon.
For many cancer patients, hope for a cure lies in the results of clinical trials, which might point to newer, more effective treatments. The 2016 announcement from the Department of Health and Human Services, which calls for making information about clinical trials more widely available, offers these patients a ray of hope. It improves people’s ability to find clinical trials in which they may be able to participate and access investigational therapies.
As a member of the biotech community, I’m delighted about the new requirements. No matter what the results might be, the more clinical trial information is shared, the faster we develop transformational diagnostic tools and therapies.
These requirements coincide with our own clinical trials journey. Our technology platforms based on the MiCK and CEER assays and now renamed ChemoINTEL and PathwayINTEL respectively, help clinicians identify the most effective targeted therapy for cancer patients. They provide patient-centric, personalized intelligence on the effectiveness of chemotherapy and targeted therapy treatments, to help support clinical decision-making and drug development. Our strategy is to conduct clinical studies to support regulatory approval of these platforms by the Food and Drug Administration.
Prior to the new rules going into effect, the sharing of summary results for clinical trials was inconsistent. Effective January 18, 2017, summary results must be posted within a year of a trial’s completion, even if the product being tested is not yet FDA-approved.
This is a step forward for patients and their families looking for promising new treatments. According to FDA Commissioner Robert M. Califf, M.D., “When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers.”
Some in the biotech community may be wary that all this transparency might interfere with their proprietary solutions. But clinical trials are everyone’s risk, responsibility and ultimately, reward.
The more information we share, whether positive or negative, the more we can drive down the cancer death rate even further. That’s good news for everyone.
.Robert Henry is the president and chief executive officer of Pierian Biosciences