Help Industry With Clinical Trial Design
Your participation in choosing the site(s) for the clinical study can help mitigate patient risk and attract participants, as well as providing useful knowledge of day-to-day living and general practicalities to researchers. Geographic and travel information is vital to the site selection process. Researchers may also be unaware of certain travel barriers (motion sickness, frequent bathroom breaks) or issues of accessibility (no accessible transit available) that will affect your patient participation.
- An established Center of Excellence Network can simplify the site selection process.
- If a Network has not been established, you may wish to suggest the Sponsor consider:
- Areas where the target population lives and normally travels.
- Barriers travel may present.
- Special accommodations that may be needed at participating sites.
- If the clinical study will involve long stays at a distant site, it may be helpful to make the Sponsor aware of how this may affect an individual or their family, and therefore also affect patient participation and retention in the study. For example,
- It may be difficult for the patient’s partner, parents, or other family caregivers to maintain their jobs.
- If the family has children who are not participating in the study, the children’s daily care or school attendance may be affected.
- The participant or their family may be far from their support network.
- Financial burden may increase if the participants medical insurance provider may not be willing to cover medical costs that occur outside the study protocol because the site is out of network.