In a big shift of focus, the personal genomics company 23andMe recently announced the creation of a new therapeutics group with the intention of developing new therapies for both common and rare diseases.
Last week, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII (Clinical Trial Databases) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health. The NIH also announced a proposal to apply the proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that all NIH-funded clinical trials be registered in ClinicalTrials.gov and that summary results be posted to the database in a timely matter. Both documents are open for a 90-day public comment period, and comments will be taken into consideration before final regulations and a final NIH Policy are issued.
Billions of dollars are spent every year by pharma companies researching and testing new cancer treatments. Although there is a wealth of valuable, historical cancer clinical trial data, it’s not available. The Project Data Sphere initiative aims to change that because large pools of data can, and should, be put to use.
The non-profit One Mind recently announced a partnership with the Intellectual Property & Science business of Thomson Reuters to further the understanding of traumatic brain injuries (TBI) and the central nervous system (CNS) . The relationship will enable researchers to collaborate and share research results on a single web platform.
In the drug discovery pipeline, Phase I trials are first used to evaluate if a new drug is safe, then Phase II trials are done to assess the drug’s efficacy, and finally Phase III trials are performed to monitor side effects and compare the drug to similar compounds already on the market. Each consecutive phase includes more people to refine the results obtained in the previous phase. A recent analysis by the Centre for Medicines Research in the UK has concluded that since 2008, the failure rate for drugs in Phase II and III clinical trials has been rising [1-2]. Phase II success rates are currently at 18%, lower than at any other phase of drug development.