Trials

• The U.S. government has provided doses of an experimental antibody drug developed by Mapp Biopharmaceutical to combat the Ebola outbreak in the Congo. • This decision marks a shift in policy, as the U.S. previously stated the treatment would only be available to high-risk American citizens. • The provision of these doses allows for the drug to be used in clinical trials, accelerating the process of determining its efficacy against the virus.

• 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.

• The FDA has issued multiregional guidance to optimize global hematology trials, emphasizing the need for better communication between regulators, trial designers, and investigators. • Key requirements include maintaining balanced regional enrollment and implementing rigorous control arms that remain relevant to the U.S. healthcare landscape. • These measures are critical to ensure that new hematology drugs successfully navigate the path to regulatory approval, reimbursement, and widespread clinical uptake.

• A federal grand jury in the Southern District of Florida charged a medical doctor and two staff members for falsifying data during clinical drug trials. • Starting around 2019, the defendants allegedly fabricated testing records to falsely indicate that human subjects had taken medications and undergone required protocol testing. • The scheme targeted trials sponsored by a pharmaceutical development company intended to evaluate the safety and efficacy of new drugs for FDA approval.

• Regulators from the AMA and EMA have launched clinical trials in the Democratic Republic of the Congo and Uganda to combat the Bundibugyo Ebola virus. • The trials will test three vaccines—including mRNA, modified VSV, and ChAdOx1 adenovirus options—alongside various monoclonal antibody treatments and antiviral drugs. • This initiative is critical because, unlike the Zaire Ebola strain, there are currently no approved vaccines or medical treatments available for the Bundibugyo virus.

Justice secretary’s plans likely to increase black people’s suspicion of court system, committee suggestsDavid Lammy’s planned changes to the criminal courts in England and Wales could have a “far-reaching” impact on race relations, a cross-party committee of MPs has concluded.The deputy prime minister’s plan to remove the right to elect for a crown court trial “has the potential to increase mistrust in the criminal justice system among the black community”, the justice select committee said, because black defendants are more likely to elect for trial. Continue reading...