Standard of Care Payment Overlap
Pharmaceutical and biotech clinical trials in the United States assume $1.1 billion in patient treatment costs that would normally be covered by commercial and public third party payers. These medical procedures are often a part of the treatment third party payers are required to provide their patients. Many pharmaceutical and biotech companies routinely include standard of care payment considerations in their clinical grant payment agreements with sites conducting oncology studies. However, this standard of care payment practice is usually not widely followed in other therapeutic areas, despite its broad acceptance in oncology. An analyses of US Phase I and III clinical studies, outside of oncology, shows that 22% of clinical trial procedures paid for by pharmaceutical companies would be covered by public and commercial third party payers as part of their standard of care treatment for these patients. Drawing upon data from GrantPlan®, the industry’s largest current database of clinical grants, and over 1 billion patient claims records, TTC and Trialytics determined that commercially funded Phase II-IVclinical trials are far more expensive than they need to be.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
