Aug 15
Opportunity
Participants expect some flexibility and do not want clinical trial participation to significantly impact their normal daily schedule. Sponsors should consider exploring solutions that allow participants to more easily find and select times for appointments, especially with increased flexibility and more diverse procedure locations.
Considerations to Help Action the Opportunity
- Understand the individual needs of each participant and their preferences
- Partner with sites to build flexibility into the clinical trial design by providing timing and location options for visits
- Explore decentralized clinical trial options, such as telemedicine and the use of local clinics and sites
Value and Potential Benefits
- Increases flexibility and ease of scheduling
- Encourages patient engagement and empowers patients
- Reduces the barriers to finding and attending appointments potentially leading to better compliance and retention
Related Blog Posts
A New Era in Advancing Care for Pregnant and Breastfeeding Patients
One major challenge facing the clinical research ecosystem is not whether, but how to study drug safety and efficacy in pregnant and breastfeeding populations. A growing number of organizations—including the ICH E21 Expert Working Group (EWG) and TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative—are diligently seeking ethical and responsible solutions to protect these…
Improving Medicine Use During Pregnancy & Breastfeeding: Forging a Path Forward
The scientific community intended to protect pregnant and breastfeeding populations when it strictly limited their involvement in clinical trials after the thalidomide crisis of the 1950s-1960s. Yet over the past few decades, people have increasingly recognized the real-life challenges posed by the lack of research into the safety of medications used during pregnancy and breastfeeding.…
Transforming Pharmacovigilance: Solutions to Solve Regulatory Challenges
Patient safety depends partly on sponsor organizations’ compliance with pharmacovigilance (PV) regulatory requirements—even when global variations exist. Helping sponsors interpret and operationalize challenging PV regulations and guidances is the goal of TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative. In this third installment of our IGR PV blog series, we will examine the solutions…