Applied Clinical Trials
Industry Standard Research
Awell documented 2008 study titled "Sensible Approaches for Reducing Clinical Trial Costs," http://ctj.sagepub.com/content/5/1/75.abstract found that investigator payments account for a staggering 48% of total trial costs. So it goes without saying that sponsors and CROs can't afford to get the investigator payment level wrong. For sponsors and CROs, not paying market-rate investigator fees impacts both the financial health of the organization and the ability to recruit high-performing and experienced sites. Pay too much and your R&D budget evaporates. Pay too little and it will be difficult to recruit experienced sites.
But planners need to know when to offer more and when to offer less. Industry Standard Research has recently published a study that identifies the factors that drive investigator fees higher and lower and benchmarked these fees across 11 therapy areas.
Intuitively it makes sense that study length and complexity would both influence investigator fees. ISR's study quantified just how much. Investigators indicated that both study length and complexity have a dramatic impact on the amount of the investigator fees. For long and/or complex studies, investigator fees can run 50% to 60% higher than for more standard studies.
Knowing what levers push and pull investigator fees—and by how much—will help optimize the use of budgets industry wide and maybe even improve recruitment rates along the way.
—Industry Standard Research, www.ISRreports.com.
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.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
May 16th 2025In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.