Clinical Trial

Legal challenge to King’s College London research study claimed it could harm participants but was rejectedA clinical trial of drugs that can delay puberty can go ahead after a high court judge threw out a legal challenge on Friday.Campaigners had launched the attempt to halt the planned research into puberty blockers, to be run by researchers at King’s College London (KCL), on the grounds that they believed it could harm the children taking part. Continue reading...

• On 28 April 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority introduced the most significant package of clinical trial reforms in over 20 years. • The legislative changes aim to accelerate the setup of low-risk trials and streamline the process for making modifications to existing studies. • These reforms matter because they are designed to provide patients with earlier access to innovative medicines by reducing regulatory bottlenecks.

• DelveInsight has released a comprehensive analysis of the global Clostridium Difficile Infections (CDI) treatment pipeline projected through 2026. • The report identifies 20 key pharmaceutical companies currently developing 22 distinct therapies to combat the infection. • This analysis is critical for understanding the evolving landscape of CDI treatment, focusing on mechanisms of action, administration routes, and FDA updates.

• New clinical trials have been launched in the Democratic Republic of Congo to evaluate the efficacy of two drugs, MBP-134 and remdesivir, against the Bundibugyo Ebola virus. • These trials are critical because the Bundibugyo species currently lacks any approved vaccines or therapies to mitigate its spread. • The outbreak has already resulted in over 1,561 confirmed cases and more than 500 deaths, according to the CDC.

• An international clinical trial has launched to evaluate potential treatments for Bundibugyo virus disease (BVD) as patient enrollment begins. • Sponsored by the WHO and coordinated by partners in the DRC, Belgium, and the UK, the study responds to an outbreak in the DRC where over 1,400 people have been diagnosed. • The trial is critical because there are currently no approved therapies for BVD, a disease that has already caused an estimated 440 deaths in the current outbreak.

• Genmab's epcoritamab showed successful results in treating diffuse large B-cell lymphoma (DLBCL), while BRUKINSA achieved a win in treating mantle cell lymphoma (MCL). • The FDA approved Tregzi for the treatment of graft-versus-host disease (GVHD), providing a critical new tool for patients undergoing allogeneic stem cell transplantation. • These developments highlight a trend of incremental progress in B-cell malignancies and transplant medicine, contrasting with the continued unpredictability of neuropsychiatric drug development.

• 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.

• 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.

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

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.

• 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.

• 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.

• Former President Trump signed an executive order in April titled “Accelerating Medical Treatments for Serious Mental Illness” to fast-track research and drug approvals for psychedelic-assisted therapy. • The order aims to increase clinical trial participation and explore innovative research models to treat serious mental health conditions. • This federal push provides a new path for psychedelic research in Missouri, where state lawmakers have failed for several years to pass similar legislation.

• Missouri State Rep. Dave Griffith is advocating for psychedelic-assisted therapy to treat veterans suffering from depression and post-traumatic stress disorder. • The initiative follows an April executive order signed by Donald Trump titled “Accelerating Medical Treatments for Serious Mental Illness,” which aims to speed up drug approvals and clinical trial participation. • The order directs the Secretary of Health and Human Services to allocate at least $50 million to support state governments developing programs for psychedelic drugs.

• Merck (known as MSD outside the U.S. and Canada) announced the publication of new clinical trial work on May 7, 2026. • The announcement was distributed via Business Wire from Rahway, N.J., targeting both healthcare professionals and consumers. • These updates are critical for tracking new drug approvals, safety alerts, and updated indications for medical treatments.

• A new clinical trial launched April 24, 2026 (NCT07549529), examines postural motor activation deficits following mild traumatic brain injury (mTBI) in US patients. • The study translates lab findings into physical therapy protocols for concussion rehabilitation, focusing on vestibular and balance impairments. • Affecting millions annually, mTBI recovery gaps could improve with targeted interventions, potentially reducing long-term disability rates by 30%.

• HHS through the National Cancer Institute announced a $200 million public-private partnership to fund clinical trials for cancer vaccines targeting high-risk recurrence patients. • The initiative supports mRNA and other vaccine types, aiming to accelerate development with private sector involvement including venture capital. • 'Nothing of this scale has been attempted in cancer vaccines before,' said Stacey Adam, VP of science partnerships for the Foundation for the National Institutes of Health.

• A Phase 2 clinical trial led by Memorial Sloan Kettering Cancer Center demonstrated that engineered CAR-T cells targeting mesothelin showed a 52% overall response rate in 89 patients with advanced pancreatic and ovarian cancers. • The trial, results published March 19 in Cancer Cell, showed durable responses lasting over one year in 68% of responding patients, compared to historical response rates below 20% with conventional chemotherapy. • CAR-T therapy has revolutionized blood cancer treatment but remained ineffective against solid tumors until recent engineering advances, potentially opening a new therapeutic avenue for 400,000 Americans diagnosed with pancreatic and ovarian cancers annually.