Clinical Trials Advisor

The FDA will begin policing compliance with clinical trial submission requirements for ClinicalTrials.gov under a policy change at HHS.

Scientific fraud is on the rise, according to a new study that found 67 percent of retracted articles in PubMed were attributed to misconduct — nearly two-thirds as a result of fraud or suspected fraud.

The NIH hopes more clinical investigators will get involved in translational science through a new Opportunities for Collaborative Research program that enables non-NIH investigators to access clinical facilities and hardware at the NIH Clinical Center in Bethesda, Md.

By sharing clinical trial data with academic partners and patient advocacy groups, sponsors can shorten a drug’s time from bench to bedside, enhance the credibility of industry-sponsored research and improve regulatory transparency.

The European Medicines Agency (EMA) will soon allow biosimilars sponsors to reference biologics made outside the European Economic Area (EEA) in some preclinical and clinical studies required for approval.

The Clinical Trials Transformation Initiative (CTTI) wants sponsors to put more emphasis on pediatric clinical research and begin observing pediatric patients for longer periods.

Drugmakers should use superiority trials when developing antimicrobial drugs for the treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), according to an updated FDA guidance.

New fixed-dose drug combinations that include at least two INDs and target a serious or life-threatening disease could be eligible for an additional six months of marketing exclusivity and priority review under a new bipartisan-supported bill sponsored by Rep. Brian Bilbray (R-Calif.).

The FDA handed Atlanta-based CardioMEMS a warning letter for deviations related to a clinical investigation and premarket approval application (PMA) for its CardioMEMS HF Pressure Measurement System.

Clinical trials of drugs to treat complicated intra-abdominal infections (cIAI) should have a primary endpoint of complete resolution of symptoms at 28 days following randomization and the absence of clinical failure, according to an FDA draft guidance.

Sponsors and sites need good standard operating procedures (SOP) to ensure the study protocol is followed, regulatory expectations are met, and deviations are identified and addressed.

An upcoming FDA final guidance on risk-based monitoring of clinical investigations will include more specifics for drugmakers on developing monitoring plans, as industry has requested.