May 10th 2024
Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.
Europe's Bid for Specialist Synergy Promises a Research Boost
April 25th 2016The European Reference Networks aims to join the efforts of the best specialists in Europe to tackle complex or rare medical conditions. The goal is to create networks covering a specific disease with an emphasis on procedures or techniques related to treatment.
Why Are Cancer Clinical Trials Increasing in Duration?
August 31st 2015An article recently appeared in Applied Clinical Trials, which indicated that oncology trials are taking longer to complete, and the article suggested that the duration of oncology clinical trials in certain phases increased by one year to one and a half years.1 Moreover, the article delineates that ameliorations in trial duration were most likely a result of increasing protocol complexi
Maximizing Recruitment of Targeted Oncology Populations
April 14th 2015While some countries are more progressive in approaching this challenge by virtue of mandatory, free of charge, molecular testing on all patients, this varies greatly in other countries based on institutional policy and insurance reimbursement.
Conducting Clinical Trials with Plasma-derived Products
January 1st 2004The process of conducting clinical trials with plasma-derived products is essentially similar to that for any pharmaceutical product. However, trials with these products do present some different challenges in terms of trial design, patient recruitment, and clinical trial supplies.