Clinical Trials Advisor

Drugmakers’ health economics and outcomes research teams must provide earlier input on clinical trials so the data generated have a better chance of ensuring reimbursement for treatments after approval, a new study says.

Drugmakers conducting clinical trials of drugs to prevent stroke and systemic embolic events (SEE) in patients with nonvalvular atrial fibrillation (AF) should use the composite primary efficacy endpoint of time from randomization to first stroke and SEEs, according to a European Medicines Agency (EMA) draft guideline.

Despite “fragile” trial data, the FDA should approve Abbott Laboratories’ proposed new indication for its blockbuster Humira to treat ulcerative colitis (UC), because new therapies for the chronic condition are needed and clinicians are comfortable with the drug’s safety profile, agency advisers say.

Adaptive clinical trials can allow sites to enroll small numbers of patients and end a trial early if the desired outcome appears unlikely, but investigators must take care to ensure that study participants understand they are consenting to a moving protocol and that patients who enroll later may see more benefits than early enrollees, a pair of recent articles in Journal of the American Medical Association (JAMA) suggests.

Drugmakers submitting electronic common technical document (eCTD) marketing applications to both the FDA and European Medicines Agency (EMA) can basically clone their submissions, but the format must be reworked to meet the needs of each agency, an eCTD expert advises.

Personalized medicines that target patients with particular genetic traits are the wave of the future and may help reinvigorate the pharma industry, but discovering these drugs will require the collaboration of multiple groups, novel trial designs and new regulatory approaches, according to an Institute of Medicine (IOM) report.

The FDA has given GI Dynamics a conditional go-ahead to launch a pivotal clinical trial of its EndoBarrier for obese patients with Type 2 diabetes without first conducting a pilot study, a tribute to the caliber of research sites used in earlier studies conducted outside the U.S., the devicemaker says.

The FDA’s Anti-Infective Drugs Advisory Committee has recommended the FDA approve Novartis’ inhaler-based version of cystic fibrosis (CF) drug Tobi, despite deficient supporting clinical study data.