Welcome to clinical site selection and evaluation Part 2, where we continue the conversation on optimizing clinical site selection and evaluation. In this episode Linda Peterson and Julie Sheidy share recommendations on how to approach site selection, how to build teams, how to communicate within organizations and across teams, and their approach to site identification.

Key takeaways include:

1. Sites often look to the CRO or Sponsor for expertise and support. A strong CRO will help the site through selection, accelerating the process.
2. Build your team around the protocol! Therapeutic area experts are needed on both the CRO/Sponsor side and the site side.
3. Anticipation and foresight are key. An experienced Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) will deeply review the protocol to identify resourcing gaps and determine how to close those gaps early in the site selection process.  They will also take the initiative to bring on internal experts or support staff early in the process to address action items within their expertise.
4. Ensure the site has access to the patient population and that the population is willing to support the study.
5. Make sure the site has the infrastructure to set run the study and identify any mismatches or pain points early.
6. Establishing clear lines of communication and setting out roles and responsibilities will make the evaluation process much faster.
7. Yes, checklists are worth it. Both the Site and the Sponsor/CRO will use them as valuable tools and the process will benefit from their use.
8. Contact advocacy groups – they are involved with local, regional, and national communities.
9. Use epidemiological data or incidence data to find areas where the disease is moderately or highly prevalent.

3:00 – How can the site and sponsor work together to accelerate site selection?

5:15 – Julie describes the traits, skills, and characteristics of a “dream team” from CRO or Sponsor perspective and from the site’s perspective.

8:45 – In the event that a CRO or Sponsor identifies a lack of resources at a particular site, is there an advantage to the CRO or Sponsor supplementing those resources?

10:50 – The importance of strong communication within and between the CRO and site “dream teams.”

14:15 – Tips for maintaining a good working relationship and culture through turnover or staffing changes.

16:30 – Best practices for site identification and site selection in the case of rare disease trials and/or common chronic disease trials.

19:15 – How do you address potential site-related bias or the impact of advanced expertise when considering major center or world-class research institutions? How do you ensure the findings are applicable to all care settings if you are conduct research at elite institutions?

20:15 – Can or should   sites advocate for altering a protocol or research question to better fit the population or their specific patient population?