Platform Trials Are Rewriting the Rules of Evidence. Regulators Haven’t Caught Up.
Adaptive platform trials like REMAP-CAP enrolled 4,869 critically ill COVID patients across 300+ sites, but FDA's master protocol guidance...
Adaptive Clinical Trial Design Adaptive Trial Design Addiction Psychiatry AI in Clinical Trials Alzheimer's Disease Article Artificial Intelligence in Clinical Trials Clinical Operations Clinical Research Clinical Trial Design Clinical Trial Operations Clinical Trial Ops Brief Clinical Trials CLINOPS WATCHDOG CNS Drug Development CNS Trials Conference Coverage CRO Consolidation Decentralized Clinical Trials Digital Health Technologies dual diagnosis eClinical Tech News eClinical Technology EMA Executive Interviews FDA Enforcement FDA Guidance FDA Real-World Evidence FDA Regulation FDA Regulatory Strategy GCP Compliance GLP-1 Receptor Agonists Ketamine Therapy Oncology Trials Opinion Parkinson's Disease Platform Trials Psilocybin MDMA Psychedelic Clinical Trials PSYCH PULSE Real-World Evidence site activation Site Operations study startup Treatment-Resistant Depression
Adaptive platform trials like REMAP-CAP enrolled 4,869 critically ill COVID patients across 300+ sites, but FDA's master protocol guidance...
Headlands Research joins SCRS Global Impact Partner program to address site sustainability and trial complexity challenges in clinical operations.
Kodiak Sciences reports DAYBREAK Phase 3 results for Zenkuda and KSI-501 in wet AMD on September 28, testing non-inferiority...
Adaptive platform trials like RECOVERY and REMAP-CAP are transforming infectious disease research, but FDA and EMA guidance still lags...
Five compounding barriers—awareness, protocol complexity, competition, hesitancy, and logistics—block rare disease patient enrollment in clinical trials.
Annamycin shows immune activation in pancreatic cancer preclinical study, with CD8+ T cells mediating antitumor activity alongside cytotoxic effects.
ELI-002 7P Phase 2 data selected for oral presentation at ESMO 2026, showing signals in patients with lower residual...
CARVYKTI achieves five-year treatment-free remission in 50% of early-line myeloma patients, with no additional therapy required after single infusion.
FDA approves baricitinib for severe alopecia areata in adolescents 12+, with 42% achieving 80% scalp hair coverage in Phase...
Evorpacept's Phase 2 data in HER2+ gastric cancer reveals a CD47 biomarker selection gap that could reshape how oncology...