Do Sites Prefer a Sponsor Company or CRO to Run Their Clinical Trial?
CROs conduct a substantial, and growing, percentage of clinical trials for sponsor companies. Drug development professionals in sponsor companies have sometimes voiced concerns about how clinical sites view working with CROs, particularly as it relates to the consequences of CRA turnover and a possible lower level of in-depth study compound knowledge.
CRO or Sponsor: Site Preferences for Trial Management
An in-person, mail, and Web-based global study of over 4000 sites demonstrates that investigators have largely come to accept CRO study management as an integral part of today's clinical research. More investigators prefer CRO management (29%) to sponsor company direction (23%). The largest number of investigators though (48%) do not care whether a CRO or sponsor company runs a study in which the investigators are participating.
The general pattern does not vary appreciably by type of site. For instance, sites such as academic medical centers and teaching hospitals, that many might expect to prefer sponsor company project management, do not. Only 18% of these investigators prefer sponsor companies over CROs. Most (54%) are indifferent between sponsor companies and CROs. The desire to work directly with sponsor companies is highest in North America (31%). Yet, investigators of all types who do prefer to work with a sponsor company are not willing to accept even a slightly lower cost per patient grant to work with these companies rather than CROs. For many investigators CRO study management is an accepted fact of their clinical research activities.—TTC (for more information, please
contact help@ttc-llc.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.
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.