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The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency.

For over 10 years, Rho has worked in vaccine research and is currently 1 of 5 contract research organizations in the BARDA Medical Countermeasures Clinical Studies Network (MCM-CSN) that designs and conducts clinical studies needed to develop drugs, vaccines, and diagnostic tests that help protect public health. Based on our experience, we understand the risks, challenges, and solutions needed to operationalize a vaccine trial.

As the number of COVID-19 hospitalizations increases, another growing threat to the US healthcare system’s ability to respond to the pandemic is emerging: shortages of essential drugs diverted from patients with their primary indications to treat patients infected with COVID-19.

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.

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.