WORLD HEALTH ORGANIZATION

The cfDNA testing market is projected to grow from $7.07B in 2023 to $20.63B by 2028, driven by advances in liquid biopsy, personalized medicine, and cancer prevalence. Key players include Roche, Thermo Fisher, LabCorp, Quest Diagnostics, and Agilent Technologies.

WHO's 2024 guidance emphasizes diverse clinical trial participation, including ethnic minorities, LGBTQI+ populations, pregnant and lactating women, low-income patients, and those with language barriers. Dr. Jeremy Farrar highlights the need to benefit the broadest range of people, moving away from a one-size-fits-all approach. The guidance aims to improve evidence quality and healthcare access for underserved populations, potentially through cluster randomized trials in resource-limited settings.

AI in healthcare is rapidly advancing, with the FDA focusing on AI-equipped medical devices. Avant Technologies, Inc. has partnered with Roche and Salud 360 for a pilot program in Costa Rica to combat diabetic retinopathy using AI. The program aims to improve early detection and treatment, with potential expansion to the U.S., Canada, and Europe. AI is also enhancing drug development, diagnosis, and treatment monitoring, with significant market growth projected in AI in Precision Medicine and Healthcare IT.

New UK legislation streamlines clinical trial regulations, fostering innovation and faster approvals, aligning with Lord O'Shaughnessy Review recommendations. Amendments focus on participant protection, medicine development, and multi-national trial facilitation. The reforms aim to make the UK a top global research site for safe, groundbreaking trials.

A flu-like illness in Congo, affecting 416 and killing 75, may be malaria; 9 of 12 samples tested positive. Most deaths are children under 14 in Kwango province. Symptoms include fever, headache, cough, and anemia. Health officials continue research to confirm the cause.

A second NIH clinical trial shows SIGA Technologies' tecovirimat ineffective for mpox, halting recruitment. The STOMP trial found no reduction in lesion resolution or pain vs. placebo in mild to moderate clade 2 mpox cases. This follows the PALM 007 study in DRC, also finding tecovirimat no better than placebo. Despite setbacks, three vaccines remain available, and three ongoing trials for tecovirimat continue.

New UK legislation on clinical trial regulations aims to enhance transparency, encourage participation, and align with global diversity and inclusion standards. Experts highlight the importance of efficient, patient-friendly trials for advancing medical care and meeting WHO best practices.

The Union government prioritizes fast-track clearances, waivers from clinical trials, and faster access to drugs for rare diseases. CDSCO directs states and UTs to approve applications within 90 days, facilitate imports, and prioritize testing of rare disease drugs at government labs.

Pooja Khatri, MD, MS, has been appointed chair of the Department of Neurology and chief of neurology at Yale New Haven Hospital and Yale New Haven Health System, effective April 1, 2025. Dr. Khatri, currently at the University of Cincinnati, is an internationally recognized expert in clinical stroke with extensive research and leadership experience.

New research highlights reduced COVID-19 vaccine efficacy in patients on immunosuppressants and hepatitis B antiviral drugs post-liver transplant, suggesting a need for additional vaccination to boost antibody levels. Study findings indicate lower antibody levels in immunocompromised patients compared to healthy controls, with significant differences observed after the third vaccine dose. No significant liver function deterioration was noted post-vaccination, but 23 breakthrough infections occurred. Further investigation into antiviral drugs' influence on vaccine responses is needed.