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Maintaining Trial Integrity During COVID-19: Some Statistical Rules of Thumb

The COVID-19 pandemic is having a substantial impact on many ongoing clinical studies in all phases of product development. Numerous difficult decisions are being made and steps are actively being taken to ensure the safe execution, or future resumption, of ongoing studies. While patient safety is paramount and should drive all study conduct related decisions, many of these decisions can impact the interpretability of estimates of efficacy at study conclusion.

Blog Post

COVID-19 FDA Response: Site Management and Monitoring

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.

Blog Post

Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD

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.

Blog Post

Development of COVID-19 Therapies: FDA Pathways

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.

Blog Post

COVID-19 FDA Response: Guidance on Protocol Amendments and Clinical Study Reports in Affected Ongoing Trials

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.

Blog Post

Changes to Study Visits and Assessments During COVID-19: Subject Safety Considerations

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.

Monica Frazier
Blog Post

COVID-19 FDA Response: Guidance Released for Conduct of Ongoing Trials

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.

Blog Post

Working with BARDA: Funding collaborations for your emerging infectious disease program

As part of BARDA’s Medical Countermeasures Clinical Studies Network (MCM-CSN), we have had sponsors ask us about funding collaborations for their infectious disease programs, including COVID-19. We understand that it can be confusing to navigate this process, and we are happy to provide some guidance based on our experience working within the BARDA network.

Blog Post

Trends in Clinical Trial Participation of Approved Drugs by Sex and Race: 2015 to 2019

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.

Samantha Hoopes
Blog Post

505(b)(2) vs ANDA: How Complex Drugs Fit In

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.