A Different Look at Protocol Procedure Complexity
A substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials,which is not true from this data.
Procedure complexity is frequently defined as the number of unique procedures and/or the amount of activity associated with a given procedure. But a substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials, unless sites around the world have decided to perform a rapidly growing number of medical procedures at no additional cost to the commercial companies sponsoring the studies. This is probably not a widespread practice.
According to this article, clinical grant costs are not increasing. But neither has the total average cost-per-patient. We should expect some variation from year to year simply because new studies will reflect a different distribution of therapeutic areas.
From two clinical grant benchmarking systems in use by sponsor companies and CROs, which use these databases to develop clinical grant cost figures in the United States. Organizations conducting nearly 80% of all Phase III clinical trials submit their clinical grant data to the IMS Health clinical grant database, GrantPlan, from which this data was gathered.
Source: University of the Sciences, Mayes College, using IMS Health Data.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
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.
FSP Outsourcing in Clinical Research: Trends and Opportunities
June 9th 2025When drug developers choose the right outsourcing strategies in clinical research, they can gain significant benefits in terms of quality, efficiency, and operational success. In its third annual Functional Service Provider (FSP) Trends Report, Thermo Fisher Scientific’s clinical research business—PPD—gathered insights from 150 global biotech and pharma leaders to determine how FSP models help sponsors address common industry obstacles.
