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Clinical investigators looking to develop new therapies for children with Gaucher disease may use multi-company, multi-arm trials or data extrapolation techniques, according to a joint strategic plan released by the FDA and European Medicines Agency. Read More
Drugmakers conducting animal trials to support the development of biological and chemical weapon countermeasures should control for animal age, health, weight and physical environment when designing study protocols, the FDA says in draft guidance implementing the Animal Efficacy Rule. Read More
A new risk-assessment framework for incorporating biomarkers into all types of clinical trials was prompted in part by the challenges, weaknesses and incongruities in international requirements, a consortium of U.S. and EU experts says. Read More
Drug companies conducting clinical trials in India would be required to pay significant compensation for the deaths of some subjects during a study, under a rule released May 29 by the Central Drugs Standard Control Organization. Read More
Sponsors attempting to reduce R&D costs and inefficiencies through joint and risk-sharing clinical development programs may actually spend longer in development, a new report says. Read More
Institutional review boards that assume oversight of a clinical trial from another IRB should give drugmakers an opportunity to address any concerns the receiving IRB has with the study before it is terminated or suspended, an FDA final guidance says. Read More
Indianapolis oncologist Ruemu Birhiray was hit with an FDA warning letter after investigators uncovered multiple procedural failures at his clinical trial site. Read More
Bayer HealthCare, Boehringer Ingelheim and Eli Lilly are the latest drugmakers to make more clinical trial data available — in line with a recent push for transparency on the part of European regulators. Read More
Manufacturers of biosimilars should take extra care in designing clinical trials and executing other steps needed to demonstrate that their products line up with reference drugs, according to key FDA draft guidance on creating versions of the complex therapies. Read More
Drug companies that redact commercially confidential information from clinical study reports in Europe will have to justify their actions, a spokesman for the European Medicines Agency says. Read More
Manufacturers conducting clinical trials in India would be required to pay significant compensation for deaths of some subjects during a study, under a rule released last week by the Central Drugs Standard Control Organization. Read More
Drug companies conducting clinical trials in India would be required to pay significant compensation for deaths of some subjects during a study, under a proposed formula released last week that lays out the conditions and amounts of payment. Read More