Clinical News Roundup for the week of March 19, 2017 with information on FDA, NIH, clinical trial applications, pharma’s reputation, and an algorithm to make trials safer and less costly.
In February 2017, trial transparency provider TrialScope announced the launch of its Trial Results Summaries Portal that was developed in partnership with AstraZeneca. The Portal is a publicly accessible website where clinical trial sponsors can inform and educate trial participants and the general public about trial results in a non-promotional and non-biased venue.
The 21st Century Cures Act has been approved by both the House and Senate, and late last year was signed into law by President Obama. The 996-page bill includes changes to the way FDA regulates drugs, medical devices, and biologics. In 2017, we have seen a change in administrations and will likely see a change in leadership at the FDA. I took this opportunity to touch base with David Rosen, co-chair of the life science practice at Foley & Lardner LLP and a law practice consultant. In this Q&A, Rosen shares his thoughts on the new legislation, changes coming to FDA, and why the patient perspective needs to remain a primary concern of the drug development industry.
The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – like genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop, the central challenge facing trial sponsors is the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
Challenge: A biotech company launched a Named Patient Programme (NPP) that required complex and dedicated operational support. The NPP demanded expedited patient eligibility review and urgent drug shipment to an extremely sick patient population. High patient demand from a global population encouraged them to seek a pharma services provider to manage the programme.
Regulators are encouraging the industry to take a new quality risk management (QRM) approach to clinical trial execution. The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 R2 guidelines represent the first update to the guidelines in over 19 years.