Clinical Trials Advisor

Clinical trial sponsors could have an easier time qualifying trial sites and training investigators as a new Big Pharma initiative aims to standardize these procedures and support mutual recognition of qualification and training.

Drugmakers should include the device component of a combination product in the pivotal trial of the drug or biologic or face additional regulatory hurdles later, a top FDA official said.

The FDA has permanently banned a clinical investigator and a research coordinator from conducting any work relating to an approved or pending drug application, following their felony convictions for knowingly falsifying study data.

U.S. healthcare fraud and abuse laws have led many sponsors to set clinical trial payment levels based on patient pricing for normal clinical care, but trial activities are much costlier, experts say, and research sites need to convince sponsors that their work demands higher pay compensation.

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and to keep up with increasingly global operations.

Sponsors banking on a regulatory approval should play it safe in late-stage drug trials.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8–0 against recommending approval of Cornerstone Therapeutics’ lixivaptan to treat hypervolemic hyponatremia associated with heart failure, citing poor trial results and dissatisfaction with use of a surrogate endpoint.

The FDA appears poised to require clinical trial data from drugmakers seeking biosimilar interchangeability designations, a move that could shrink the number of products that aim to achieve the standard, drugmakers and legal experts say.

Drug manufacturers should prepare to use the updated version of Module 1 of the electronic common technical document (eCTD) by September of next year, even though it will likely remain optional until 2015, FDA officials advise.

Despite pressure from senators at a roundtable on the implementation of the Physician Payments Sunshine Act, a representative from the Centers for Medicare & Medicaid Services (CMS) simply said the agency hopes the rule will be released soon and that manufacturers’ data collection will begin in 2013.

Drug sponsors may be able to avoid establishing in vivo bioequivalence as part of safety and efficacy data requirements in situations where in vitro data provides a reasonable estimate of the relative in vivo performance of the two products, according to a new Health Canada draft guidance.

Drugmakers can use a new FDA-sponsored website to make faster decisions on what experiments or analyses are needed to check for potential drug interactions.