If this pandemic has taught us anything it’s that the future is now – so what are you going to do about it? Deep dive into where we are headed and where new goals should aim.
- Example of innovation applied to advance clinical trials from those on the front lines
- Utilize novel digital tools for better recruitment and retention
- Discover the pivots in the protocol plans that propelled the success of future trials
- Discuss innovative ways to keep momentum of the positive exposure to decentralized trials and drive towards other medical areas outside of COVID 19
Explore remote collection of Glycaemic and Behaviometric data among patients with Type 2 diabetes Mellitus. Hear about the challenges and future prospective of the study,
- Explore study design and data collection via e-devices
- Operational considerations
- Discuss the patient perspective
The sponsor can document protocol deviations using its standard processes, or use alternative documentation approaches. What sort of infrastructure is needed to support decentralized trials?
- Develop a concrete plan and update your SOPs or guidelines
- Focus on what working practices are today and how are they differ from a year ago
- Introduce permanent procedures to capture documentation
Delivery of mobile clinical services (e.g. mobile nursing, home biologic sample collections, training on equipment use and protocol compliance) depends on smooth coordination between the sponsor, CRO, sites, central lab, and the mobile clinicians. The old paradigm of using paper for source data collection comes with many inherent problems; switching to a fully-digital workflow addresses these issues while also improving study efficiency and promoting tighter connections between the stakeholders.
- PIs are able to easily order and monitor the conduct of mobile clinical visits,
- There can be a transparent view to the services ordered, the status of the orders, all via a unified dashboard
- A unified solution based on an integrative technology platform is essential for providing high touch care which enhances the patient experience
Why are companies slow to adopt decentralized trials? Review the current situation with the pandemic and see how these trials can lead to more diverse and patient-centered trials. Increase patient diversity in trials Tackle recruitment and retention in trials head-on Explore opportunities to reduce the burden on patients
Decentralized trials may potentially unlock new advantages in quality, recruitment, and retention – but are you set up to bring these processes to operational life? You could access patients that were previously unable to participate in clinical trials, if only you establish and test the best processes.
- Identify what procedures can be implemented at home
- Ease travel burdens for patients and improve engagement of local clinical facilities to conduct activities
- Understand the laws and regulations that allow and don’t allow DCT in various locations
If all stakeholders can agree on the new best standards, you can be poised to reduce both the time and cost of clinical trials, as well as improving patient outcomes and QOL. But are you set up to gather and act on all the feedback you need?
- Discover invaluable benefits of increased collaboration and data sharing among the scientific community
- Explore collaboration efforts to ensure quality at the investigational site level and quality within the trial with sponsor
- Understand how FDA and EMA watch, influence and contribute to collaboration
Decentralized clinical trials can improve safety monitoring and patient follow up. How can we make sure these new efficiencies are available for the patient’s access?
- Importance of communication in the trial
- Design the trial with the language of the protocols
- Ensure not to sacrifice quality along the way
- Explore case studies and key learnings from rapid DCT adoption over the past year
- Share direct feedback from patients and physicians from underrepresented communities on how to enhance DCT access and optimize the trial experience
- Highlight exciting innovations that will facilitate continued evolution of the DCT model
Personalization Approach to Obtain Accurate Assessments of Patients with Limited Face to Face Interaction
The effect of decentralized trials on the patient experience is both positive & negative. How do DCTs help the trial get a clearer picture by seeing the patient in their own environment?
- Provide a personalization approach to enhance participant experience
- Analyze the new variables introduced by multiple patient settings
- Utilize patient advocates properly to enhance your studies
- Explore effective strategies to conduct real-time video use of telemedicine for remote clinical trial visits
- Understand how role of digital biomarkers in these studies
- Learn about ongoing decentralized research studies
Conceptually, an ideal endpoint should be a valid and applicable measure of how a patient feels, functions or survives and be perceived by end-users of the research as having meaning and value. It is a responsibility of those who design and conduct trials to choose endpoints which will influence decision-making by clinicians and policymakers.
- Discuss the tools that will be used for endpoint measurement
- Cover mobile technologies to collect endpoints in decentralized trials
- Use patient engagement to define meaningful change, select endpoints and develop/select PROs
