In this post, the focus is on site management and monitoring changes during COVID-19. With a focus on participant safety and trial data quality and integrity, the FDA expectation is that sponsors will identify alternative approaches to on-site monitoring and document these in updates to the Clinical Monitoring Plan.
Generating Antibiotic Incentives Now (GAIN) and the Qualified Infectious Disease Product (QIDP) designation and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), described below, were designed by the FDA to streamline development and encourage investment into targeting infections that lack effective therapies.
At a high level, there are basically 3 (inter-related) programs that FDA has in place to make drug product available for COVID-19 patients in an expedited manner or under an “emergency” use status for products that are ready to initiate clinical studies, are already undergoing clinical development prior to approval of a new drug application, or are already approved in other indications: CTAP, EUA and Expanded Access.
One of the impacts of the COVID-19 pandemic on the conduct of ongoing and planned clinical trials will be the need for protocol modifications to adjust for COVID-19 control measures and COVID-19 illness. The recent FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic offers advice on managing protocol amendments and deviations and documenting changes to the trial.
The COVID-19 pandemic has understandably generated a surge of concern among clinical researchers about how best to minimize the risk to study subjects of exposure to COVID-19 while also preserving study integrity and a favorable risk-benefit of study participation for subjects. In general, research principles don’t change because the world is going through a public health crisis, and the principles of Good Clinical Practice, risk-benefit, subject safety, and ethics remain as fundamental priorities of clinical research.
This blog post serves as an introduction to a series of posts related to maintenance of the reliability and validity of ongoing clinical trial data during the COVID-19 pandemic. The FDA Guidance on conduct of clinical trials of medical products during the COVID-19 pandemic, released initially on March 18th and updated on March 27th (with questions and answers), provides support for industry, investigators, and Institutional Review Boards (IRBs) managing these new challenges.
Diversity in clinical research is important for ethical and scientific reasons. When women and non-White populations are not represented in clinical research, this limits our understanding of the safety and efficacy of drugs to treat important health issues in these populations. Learn more about these findings in Yael Symes’ comprehensive blog.
While it is important to understand how to navigate the complex generic drug approval pathway, it is first necessary to determine whether your drug product should be submitted as an abbreviated new drug application (ANDA) for approval as a generic or if it requires submission of a 505(b)(2) new drug application. This particular issue is addressed in a draft guidance “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” Our blog will help you understand when a 505(b)(2) application is appropriate and when an ANDA is appropriate.
How can we ensure that successful clinical trial interventions will lead to long-term improvements in healthcare? Novel research and information dissemination projects like the CHAMPS program offer promise for bridging the gap between clinical trials and health practice.
Rho representatives joined regulators, industry scientists, and numerous patient-advocacy groups at CBI’s Rare Disease Clinical Development and Access Summit in Washington. Attendees were able to share best practices in product development for rare disease programs in formal presentations and through informal networking. Here are 4 considerations for your development program that were highlighted during the conference.
Attending PAINWeek this year was especially meaningful because pain research has been a major part of my career. Over the past 12 years, I have worked on more than 50
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Acute pain trials start with assumptions. How you execute—when reality sets in—determines the outcome. When you’re designing an acute pain clinical trial, it’s perfectly normal to have some early assumptions
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When Tonix came to us, the stakes were high, and the timelines were tight. Their goal? To submit a New Drug Application (NDA) for TONMYA™ and, for the first time
Every CRO out there will tell you they’re site-centric, and on pitch decks, they use the right buzzwords to prove it. Curious. Collaborative. Dependable. Problem-solvers. Sound familiar? That’s great in
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