Site Values Program
These shared values were developed by stakeholders in drug development to demonstrate
values that are important for investigative sites.
Sites that commit to putting these shared values into practice will be signaling
to their partners that they understand the importance of these issues in improving
drug development and putting patients first.
Below is the list of core values with actionable steps sites can take to develop
a common ethical foundation. This list is not meant to be final but to be a working
document to be shaped as industry changes occur.
- Ask sponsor for site data at end of study – aim for quality improvement based on results
- Take steps to minimize dual enrollment
- Commit to recruit the most appropriate subjects for trials
- Develop rater quality and training plans
- Offer insight and consultation prior to study inception
- Provide ongoing feedback to sponsors on protocols and vendors
- Conduct accurate and robust feasibility processes
- Share metrics and successful recruitment techniques on similar studies
- Facilitate peer to peer discussions on trial challenges and sharing of best practices
- Continue to identify more efficient and creative ways of conducting clinical trials
- Leverage existing technologies to enhance recruitment, patient experiences at the site and with sponsors
- Advocate to evolve clinical trial methodology to be more about the patient experience
- Commit to site staff engagement and education to ultimately help sponsor and patient relationships
- Develop Standard of Care procedures – inform/develop relationship with subject physicians during study participation
- Commit to community awareness, patient advocacy and education- outreach to engage patients, families, and practitioners to help de-stigmatize clinical research
- Include a patient aftercare program either through community and/or professional resources
IF YOU ARE INTERESTED IN JOINING THIS INITIATIVE, PLEASE SUBMIT YOUR INFORMATION BELOW.