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The FDA’s rules for clinical investigators cover a lot of ground, from how to avoid financial conflicts of interest, to delegating investigator authority to other members of the trial team, to hiring—and sometimes firing—investigators under your charge. The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but even those documents can’t answer every question you may have about the people who actually conduct the trial. Read More
The FDA does not intend to object to an institutional review board waiving informed consent requirements for certain clinical investigations considered to be “minimal risk,” according to a new agency guidance effective immediately. Read More
The FDA and the European Medicines Agency released a draft joint plan this month to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can apply to rare diseases in general. Read More
Clinical researchers can use mobile technologies to improve the trial process if they focus on patient-centric measures and engagement with regulators, according to the Clinical Trials Transformation Initiative (CTTI). Read More
In a June meeting, the FDA’s pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials. Read More
In developing future clinical trials, sponsors should consider whether the drug will be intended for use as a single agent or as part of a combination therapy, said members of the Oncologic Drug Advisory Committee’s pediatric subcommittee, in a meeting last month. Read More
An FDA advisory committee voted unanimously to recommend to the agency that a diabetic drug is not associated with excessive cardiovascular risk, and also voted 17-to-2 to recommend an added indication that it reduces heart risks in patients with type 2 diabetes. Read More
The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties. Read More
The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource—the staff of its Office of Good Clinical Practices (OGCP). Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Here are FDA’s answers to a couple of those questions. Read More
The FDA highlighted two fictional case studies it published on the role biomarker qualification plays in drug development — as part of a reorganization of the agency’s biomarker materials — to help drugmakers understand the validation studies necessary to support qualification, the collaborative efforts involved and the potential benefits. Read More
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials, as part of an agency “innovation initiative” announced July 7 by Commissioner Scott Gottlieb. Read More