The agency recommends that sponsors can use analysis of covariance (ANCOVA) to adjust for differences between treatment groups in relevant baseline variables, but should not use ANCOVA to adjust for variables that might be affected by treatment. (Regulatory Focus)
FDA provides Guidance on oncology endpoints
This December 2018 guidance from the FDA discusses how different oncology endpoints can serve different purposes depending on the context, and provides the agency’s recommendations on which endpoints are to be considered in several different contexts. (Regulatory Focus)
FDA publishes draft guidance on patient experience data
The U.S. Federal Drug Administration (FDA) is offering the opportunity to stakeholders to submit to the FDA a proposed draft guidance on patient experience data, and has published new draft guidance (December 2018) to guide them. According to FDA Commissioner Scott Gottlieb, “Today’s guidance document is part of our commitment to advance patient focused drug development and is one of several guidances that we’re developing regarding the collection of patient experience data…” (Regulatory Focus)
New FDA Guidance on “first-in-human multiple expansion cohort trials”
The FDA has published a draft guidance that provides sponsors with recommendations for designing and conducting first-in-human (FIH) multiple expansion cohort trials within their oncology development programs. The guidance defines this type of trial as “an FIH trial with a single protocol with an initial dose-escalation phase that also contains three or more additional patient cohorts with cohort-specific objectives.” (Clinical Leader)
FDA developing guidance on patient engagement in medical device trials
FDA’s Patient Engagement Advisory Committee (PEAC) is seeking public input to inform its draft guidance on developing patient-oriented medical device trials. This call for feedback is part of PEAC’s charter in 2017 to include patients in the device regulation process. The forthcoming FDA guidance intends to demystify patient engagement in the clinical trial process. (MEDTECHDIVE)
FDA’s CDRH publishes list of upcoming 2019 guidance documents
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published three lists of guidance documents that could be published in the next fiscal year. On the “A-list” of guidance documents that the agency “fully intends to publish” is a Draft Guidance, “Patient Engagement in Clinical Trials.” (Regulatory Focus)
FDA releases new clinical research draft guidances
The FDA released two draft guidances- one on adaptive clinical trial designs, and one on master protocols for cancer treatment. An adaptive design is a clinical trial design that allows for modifications to the design based on accumulating data from patients in the trial. Master protocols, also known as “umbrella” or “basket” trial designs, test multiple drugs and/or multiple cancer subpopulations in parallel under a single protocol.
FDA updates guidance on reimbursement for patient travel in clinical trials
The FDA has updated its guidance clearly allowing reimbursements to patients in clinical trials for lodging and travel to and from trial sites, and these payments are not considered to raise issues regarding undue influence. However, other aspects of proposed payment for participation could present an undue influence, and ethics reviews should continue to examine how much compensation participants receive. (CenterWatch)
New book. “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It”
Drugs must undergo two clinical trials before being allowed on the market, but the overwhelming majority of medical devices that are on the market that are implanted in patients undergo no clinical trials. The 21st Century Cures Act passed in 2016 allows the level of evidence that’s used to approve medical devices to degrade even further. (wbur.org)
New FDA Guidance October 2017
Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers . Guidance for Industry was updated in October 2017 from the June 2016 edition. This guidance provides information about the implementation of FDA’s regulations on expanded access to investigational drugs under an investigational new drug application (IND). Expanded access refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient’s condition rather than to obtain the kind of information about the drug that is derived from clinical trials. (fda.gov)