Clinical Trial

• A randomized platform trial has launched in the Democratic Republic of Congo to evaluate therapies for the Bundibugyo virus, a strain of Ebola with no existing licensed vaccines or treatments. • The study tests whether the monoclonal antibody MBP134, the antiviral drug remdesivir, or a combination of both can improve survival rates across patients of all ages. • Managed by the DRC’s National Institute for Biomedical Research, Oxford University, and the Institute of Tropical Medicine in Belgium, the trial utilizes four groups, including a control group receiving standard high-quality care.

• Paradigm Health formally submitted its response to the U.S. Food and Drug Administration's (FDA) Request for Information (RFI) regarding the Real-Time Clinical Trial (RTCT) Initiative on June 30, 2026. • As the sole technology provider currently operationalizing the FDA's RTCT proof-of-concept studies, Paradigm Health based its submission on insights from biopharma sponsors and healthcare providers. • This move is critical for refining the framework of real-time clinical trials, aiming to accelerate drug development and improve the efficiency of regulatory oversight.

A clinical trial testing two drugs against the Bundibugyo ebolavirus, which is driving a fast-moving outbreak in Central Africa, is set to begin next week, WHO officials said.

FDA's early-stage clinical trial program, a mysterious single patient gets retatrutide access, and more health news from Morning Rounds

• The Trump administration announced a multi-pronged initiative on Monday aimed at strengthening the early clinical trial ecosystem within the United States. • As part of this effort, the FDA will reconsider Regenxbio’s gene therapy designed to treat Hunter syndrome, a rare pediatric disease. • This move represents a reversal of previous regulatory rejections, signaling a shift in how the agency evaluates certain high-stakes therapies.

• The U.S. Department of Health and Human Services (HHS) and the FDA have launched an "unprecedented" initiative to restore American leadership in clinical trials and counter competition from China. • A key component of the plan is an expedited investigational new drug pilot program designed to reduce early trial timelines by as much as 12 months. • Health Secretary Robert F. Califf stated the effort aims to reverse the trend of clinical research moving overseas by making the U.S. the premier location for medicine development.

• The U.S. Department of Health and Human Services (HHS) has launched a coordinated, department-wide initiative to restore American leadership in clinical research. • The ONC is working to integrate clinical trial notifications into electronic health records to connect eligible patients with research opportunities during routine care. • ARPA-H is implementing modernization programs, including THRIVE and CATALYST, which utilize AI and machine learning to optimize dosing and predict safety before patient enrollment.