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The European Medicines Agency is considering new trial designs using pathologic complete response, or pCR, as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early-stage breast cancer. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to the European Medicines Agency verifying that the information used to gain marketing authorization remains valid in practice. Read More
The European Medicines Agency is recommending that clinical trial sponsors evaluate local tolerance of medicinal products at contact sites on the body as part of a trial’s general toxicity studies. Read More
The FDA is creating tough new standards for clinical trials that use live case presentations, requiring that devicemakers discuss all potential risks and benefits in their investigational plans. Read More
Failing to communicate with a sponsor in a timely manner or collect data from clinical sites may be signs that a CRO isn’t doing its job — and a sign that it’s time for the sponsor to find a new partner, experts say. Read More
European drugmakers are praising the clinical trials regulation advancing through the EU Parliament, with the continent’s largest pharma group saying it will dramatically improve the efficiency of clinical studies. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More
The FDA is proposing a voluntary program to speed the approval of medical technologies that address unmet needs for life-threatening and irreversibly debilitating diseases. Read More
Drugmakers providing postmarket benefit-risk assessments to Health Canada will soon need to follow rigid, standardized guidelines that provide both preapproval and postapproval data about a drug’s efficacy. Read More
Drugmakers and nonprofit collaborators are releasing results from failed cancer trials so that investigators can search the datasets for signals or other useful information that may suggest new research directions. Read More
The UK’s Health Research Authority hopes to reduce the number of failed clinical trials by helping drugmakers do a better job justifying their trial designs and protocol assumptions early on. Read More
Sponsors are praising the FDA’s efforts to loosen restrictions on trials for drugs that treat community-acquired bacterial pneumonia, but want clarification on what the agency expects to see for efficacy endpoints. Read More