CROs must change to fit skin and aesthetics focused trials, study says

CROs need to improve CRA training to better support developers working on dermatology and aesthetic-focused trials according to new analysis.

The study – published in the Journal of Clinical and Aesthetic Dermatology – quizzed researchers about the role contract research organizations (CROs) play in clinical trials involving dermatological products as well as those involved in aesthetic treatments.

A key finding was that contractors are very important in such studies according to the authors, who wrote “the study participants acknowledged the potential benefits of working with a CRO, such as project, data and resource management, and the availability of the most sophisticated technology.”

Specific positive CRO experiences included warnings about impending expirations of institutional Review Board (IRB) approvals, Good Clinical Practice (GCP) and Clinical Laboratory Improvement Amendments (CLIA), and medical licenses. They can also share knowledge about common problems between clinical trial sites and the means for their resolution.”

CRAs, EDC

However, while the respondents acknowledged the benefits of working with a CRO for dermatological and aesthetic research, they also highlighted areas where the interaction between contractors and researchers could be improved.

“There were numerous concerns with existing CROs. Many of these issues are regarding clinical research associates (CRAs) that are too few in number, sometimes poorly trained and do not respond to researchers as needed in a timely manner, and the lack of alignment between the CRA, CRO, and sponsor.”

Other respondents raised concerns about the high turnover rates of CRO personnel “leading to poor communication and follow up.”

A lack of technology alignment was also highlighted as an issue, with some respondent’s reporting that in some cases, CROs’ electronic data capture (EDC) systems did not match source documents.

Still other respondents said they had experienced a “lack of assistance during FDA audits and difficulty contacting CRO finance teams.”

The authors conclude that “CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.”

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