Drugs

Draft Guide on Modernizing Clinical Trial Designs

FDA has released a new draft guidance that is intended to modernize clinical trial designs in oncology drug development. “The approach we’re describing in new guidance today is to help innovators to evaluate drugs in trials that are potentially lower cost, more efficient, and could enable us to learn more about the safety and efficacy when compared to traditional trial designs,” FDA commissioner Scott Gottlieb says in statement. “We’ve outlined how drug developers can use an innovative seamless trial design in early stages of oncology drug development – specifically, the first time they’re tested in humans – that compresses the traditional three phases of trials into one continuous trial, called an expansion cohort trial.”

Gottlieb explains that wasted time and costs during clinical development is attributed to waiting in between the start and end of the phases of trials. “Expansion cohort trials can bring efficiency to drug development, potentially reducing development costs and time,” he says.

The draft guidance, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics, provides advice on designing and conducting adaptive trial designs in which pharmaceutical companies and researchers can assess many different aspects of a drug in development in a single clinical trial while enrolling the minimum number of study participants necessary to obtain this information. It provides recommendations on: (1) characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial; (2) information to include in IND submissions to support expansion cohorts; (3) when to interact with the agency on planning and conducting multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in such studies.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome