Offer Location of Procedures

Opportunity

Flexibility to choose the location for clinical trial procedures (i.e., onsite or offsite [e.g., at home, local clinic, etc.]) can reduce burden on clinical trial participants in terms of travel requirements. Reducing the need to travel to the site for all visits can have a positive impact on recruitment and retention (e.g., giving flexibility around work, childcare, etc.), facilitating participation by individuals located further from clinical sites.

Considerations to Help Action the Opportunity

• Understand conditions that are required for trial conduct and how best to implement them at offsite location(s) to maximize flexibility of participation by utilizing telehealth visits, home nursing, local facilities, mobile clinics, pharmacies, satellite sites, etc.
• Define how study assessments can be performed with the consistency to clinical trial standard, such as:
  • Processes to implement protocol (e.g., teach-back technique, real-time monitoring of assessment completion, etc.)
  • Safeguards to help confirm that equipment will work correctly (e.g., calibrated equipment, internet access, back-up options, etc.)
  • Access to resources in case of emergencies or to help maintain participant safety (e.g., home nurse training, emergency medication, proximity to emergency care facilities, etc.)
• Understand that some visits can be onsite if required, for example, if IMP stability / preparation requirements do not allow for home administration or a physician needs to physically see the participant 
• Understand the amount of time procedures take and associated travel time to and from clinics (e.g., travel time could be reduced by offering local lab visits and / or remote visits)
• Partner with investigative sites to leverage their own resources and processes, as applicable, to facilitate offsite visits, and to understand and mitigate challenges / concerns associated with third-party, such as:
  • PI accountability and oversight 
  • Plan for alternative / backup in case of required / requested changes (e.g., independent providers that carry out procedures who are not directly controlled by the sponsor or investigative site including PI oversight) and participant oversight
• Define data delivery plan / map to support compilation of data from various locations / care delivery settings

Value and Potential Benefits

• Brings the clinical trial closer to participants that live far away from the clinic or when clinic visits are logistically complicated to arrange based on personal circumstances (e.g., patient mobility, desire to travel)​
• Increases convenience to participate by accommodating various options for the delivery of care​
• Allows for flexibility for site staff (e.g., focus on difficult visits vs. simple blood draws) to utilize their time more efficiently and potentially reduces the need for additional operating hours​ (e.g., weekend and evening visits)
• Potentially allows sites to conduct more clinical trials (e.g., less on-site visits may result in more availability to run trials)