Including clinical research sites in regulatory inspection preparedness planning is among the most effective actions sponsors and CROs can take to build positive relationships with sites, according to a new white paper, “Becoming a Sponsor or CRO of Choice: The Site Perspective,” released today by the Association of Clinical Research Professionals (ACRP) and The Avoca Group.
“This new research shows strong support for the importance of including sites in inspection preparation plans, as it not only mitigates compliance risk, but also has positive influence over site relationships,” says Patricia Leuchten, Founder and CEO, The Avoca Group.
The research was conducted by The Avoca Group over an 8-week period in early 2018. In this research, investigational sites were asked to rate sponsor and CRO attributes (including responsiveness to questions, knowledge of the study protocol, and frequency of CRA turnover, among others) and study execution (including setting of realistic patient recruitment goals, design of CRF, and ease of EDC systems, etc.).
“This research further validates the importance of the site perspective – and input – in the efficient and effective delivery of new treatments and therapies,” says Jim Kremidas, ACRP Executive Director.
Other key findings:
- Sites expressed satisfaction across all attributes of study design assessed. On a relative basis, consideration of the patient perspective and ease of execution of the trial ranked lowest.
- Study closeout, inspection preparation support, and communication showed strong correlation with Net Promoter Score.
- Sites are looking for the same things in the sponsors and CROS that they interact with: good communication; sounds and thoughtful protocol design; and quality partners.
The white paper concludes with four key recommendations for sponsors and CROs to become “partners of choice” with sites:
- Focus on protocol quality and design studies with site feasibility in mind, specifically focusing on entry criteria and schedule of visits and procedures.
- Ensure that staff are adequately trained and knowledgeable regarding the protocol and indication under study.
- Commit to provide sites with clear, concise, and timely communication, and be available and responsive to questions and/or concerns.
- Support the site through the lifecycle of the study, including study close-out and inspection preparation.
To download the full white paper, visit acrpnet.org/choice.