With the global virtual clinical trial market value estimated to expand at a compound annual growth rate (CAGR) of 5.1% from 2020 to 2027 from a baseline of $7.0 billion in 2019, the era of DCT is here to stay. With thise increased adoption, it is important to have a clear understanding of what it means to decentralize a trial, how adopting this approach can help improve patient-centricity and study enrollment regardless of size or therapeutic area.
- Learn what is myth and what is fact about decentralizing a trial
- Discuss the plethora of benefits DCT offers including improving diversity and inclusion
- Restructure internal processes as needed for implementation
- Understand the common challenges and possible solutions when executing a non-traditional clinical trial
Remote trials are more “patient-centric” by nature, but it takes a level of understanding, planning, and preparation to ensure trials are frictionless and engaging for patients.
- Discover how to build trials that fit within the lives of patients
- Create trial protocols that are transparent and fit patient needs
- Prevent patient pushback against research studies that ask them to come in for visits they perceive as unnecessary
- Highlight the most impactful areas to incorporate the patient’s voice into the trial process
- Reduce the site visits to decrease the burden for both patients and caregivers, contributing to patient retention
Our world is forever changing; the desires, challenges, and day-to-day needs of every person need to be understood and mastered so we can provide meaningful solutions to everyone. Human-centered design (HCD) approaches in life sciences strive to support the development of innovative, effective, and person-centered solutions. Although their use is increasing, there is no integral overview describing the details of HCD methods in health innovations. HCD won’t replace your agile framework solutions, but it will provoke different thinking going into your implementations – and that’s what we want. Human-centered design that can power successful clinical trials for everyone, everywhere.
- Learn characteristics of human-centered design approach that are vital to consider - including desirability, feasibility, and viability
- Name the building blocks that drive meaningful human-centric research
- Apply a simple 5-step model to the context of target necessary conditions
- Cultivate the flexibility to enable participation for all study-level personas
Our Interactive Discussion Groups optimize peer-to-peer learning by crowdsourcing solutions to common challenges surrounding deploying and scaling DCTs. The connections you make will become your most valuable takeaways.
- IDG 1: Examine Technology Changes Needed to Manage Drug Supply in DCTs
- IDG 2: Explore Innovative Training Strategies for DCTs
- IDG 3: Achieve Buy-In and Adoption from Stakeholders
- IDG 4: Ensure Patient Adherence and Compliance
A decentralized trial is about more than just introducing new technologies or digital tools. Transformation requires rethinking old ways of working and adopting new behaviors.
- Discuss common challenges encountered during digital transformation
- Highlight the importance of effective change management in implementing new technologies
- Factor operational challenges into the planning stage
- Establish collaborative relationships with external partners
- Share lessons learned and recommendations on how to prepare for a successful transformation
The adoption rate of decentralized trials is expected to increase to more than 50% by 2024. As this novel method of conducting studies continue to reduce patient burden and remove barriers to access, the drive to implement at full enterprise scale is escalating. What are the most important challenges you face in broader DCT adoption – and how can you find the best solutions?
- Maintain quality and integrity through clinical operations best practices and technology
- Practical strategies for leadership buy in to drive adoption
- Ensure a consistent definition for DCTs across the organization
- Align and engage cross functionally to successfully scale DCTs
- Engage in collaborative partnerships with service providers to scale DCTs
COVID placed greater industry emphasis on remote and decentralized clinical trials, which can be particularly helpful for late-stage studies. DCTs represent a paradigm shift that can yield a greater level of diversity in trials than previously seen.
- Build off guidance from FDA Office of Minority Health and Health Equity to engage diverse populations
- Recognize additional costs outside of the traditional model
- Ensure that your organization can utilize the new structure
- Discuss how a decentralized approach enhance diversity and inclusion
The large retail pharmacy chains played a crucial role in COVID-19 vaccine testing and administration. Building off this level of patient engagement has led to broader trial implementation in surroundings that participants find more convenient, effective, and trustworthy. What procedural and messaging changes should biopharma companies and retail pharmacy chains emphasize?
- Grasp that patients find retail pharmacy locations more familiar and comforting than hospital or other clinical surroundings
- Rely on pharmacy networks in socially vulnerable and medically underserved locations to broaden messaging, education and recruitment for diversity among trial participants
- Recast FDA’s expectations and regulatory burdens within a frame of what retail pharmacy can achieve
While ePRO has been a longstanding method of improving the patient experience and data quality in clinical trials, we can extend the same technology workflows used to deploy a PRO assessment to support other critical activities of a clinical trial. IP compliance and the recording of symptoms can proactively address concerns around remote trial participation, supporting sites to remain engaged with patients and enabling investigators to oversee the safety of the patient’s trial experience while minimizing the addition of burden to any of the parties.
Novel trial designs still need hard endpoints for safety and efficacy. Wearable sensors can provide passively-obtained continuous real-world data from subjects in their own habitat, facilitating decentralized trials.
- Review the uses and future applications of data from wearable sensors
- Choose the right sensors and biometrics that become meaningful endpoints in the appropriate context of use
- Focus on regulatory approval and acceptance of digital biomarkers as trial endpoints - and how this will enable their broader utilization
What are the most important current challenges with capillary samples? This session provides a deep review of biospecimen management during decentralized trial operations.
- Track emerging trends and new care settings for sample collection and management
- Focus on innovation in capillary collection
- Internalize best tracking methods across multiple sites
Decentralized trials are a trending concept brought into greater focus by the global health pandemic. With RBQM as the foundation required for decentralized and virtual clinical trials, the clinical research industry needs to ensure that new data oversight strategies required for decentralized clinical trials are in place to detect and prevent issues early in the process.
- Obtain an overview of challenges in implementing RBQM in virtual trials
- Evaluate risks involved in virtual trials
- Analyze challenges in monitoring risks with current RBQM practices
- Develop risk-based monitoring strategies which identifies Critical to Quality (CTQ) factors