The adoption of decentralized trials rapidly accelerated due to COVID-19. The pace of adoption has been challenged lately by several factors including negative economic trends, implementation slowdowns, technology misalignment with sites, and regulatory ambiguity. What strategies can teams, organizations and the research community at-large implement to maintain progress toward improving research access for all?
- Explore today's adoption challenges both within companies and across the industry
- Discuss adoption and hype curves and where decentralized research stands today
- Learn the strategies needed to sustain progress in a challenging environment
FDA’s draft guidance issued in May 2023 recommends how sponsors, investigators, and other stakeholders can, “satisfy regulatory obligations in the context of DCTs and advance the use of such studies in the future.” What specifically does this mean for your trial pipeline? Is your team properly prepared to stay in compliance?
- Explain the provisions that the draft guidance outlines
- Consider what the future of DCTs will look like based on the context of this document
- Debate the lack of clarity in some areas and how to address those instances
Generative AI and updated software are continually evolving, poised to become the “next big thing.” DCTs have a larger use for AI because of the need to use digital health devices to track and record patient data. Even though AI is beneficial, there can be many challenges such as inconsistent data management, the accessibility and affordability of new technology, and the inherent bias in the research database. Because of these challenges, is it better to stick with old technology rather than adopting new software?
- Interpret how AI can be used to harness patient data in DCTs
- Present the challenges presented surrounding tech affordability, bias, and inconsistent data management
- Contrast the benefits and challenges of sticking with new vs. old AI technology
Leveraging tools patients can use at home to collect samples has the power to change decentralized studies, both in terms of data and patient access. Combining self-collected samples with powerful multi-omic assays for longitudinal studies can reveal new biomarkers and drug targets that would be overlooked in cross-sectional and centralized study designs. This is specifically useful for diseases displaying waxing and waning symptoms, such as inflammatory bowel disease and rheumatoid arthritis. Furthermore, how can this decentralized approach enhance patient diversity, compliance, and retention in studies?
- Discuss the importance of at-home sampling and multi-omics assays
- Look at insights gathered from longitudinal sampling of flares
- Examine how a decentralized approach impacts patients involved in studies
Now that decentralized and hybrid trials have gained widespread acceptance, a significant challenge lies in achieving uniformity in regulatory policies, particularly regarding the use of eConsent. The use of digital tools to obtain informed consent from patients offers significant benefits in efficiency and accessibility. However, the diversity of eConsent methods, such as remote signatures or paper-based consent, can lead to complexity. Establishing uniform standards for eConsent across DCTs could streamline this process and enhance its effectiveness.
- Explore the role of eConsent in enhancing decentralized and hybrid clinical trials
- Uncover the challenges, advantages, and disadvantages posed by the diversity of multiple eConsent methods
- Discuss strategies for achieving uniformity in eConsent processes to enhance decentralized and hybrid trials
The growing acceptance of Telehealth has widened the scope for broader patient outreach and accessibility to clinical trials. However, transitioning from a traditional trial to a fully decentralized clinical trial model presents numerous challenges, including the requirement for regulatory acceptance of endpoints administered in the DCT model. Modeling a fully decentralized trial that mirrors a traditional trial enables comparison and validation of the operational concept of clinical trials.
- Examine the trial designs for DCTs vs traditional trials
- Explore the challenges and lessons learned from a fully decentralized clinical trial
- Consider how this data applies to future DCTs
This case study will focus on the significance of designing an adaptable IRT (Interactive Response Technology) system to support a home treatment study. Your team should realize how protocol design and IRT systems impact IMP (Investigational Medicinal Product) distribution capabilities. To better ensure a seamless DTP (direct-to-patient) experience at sites and for patients, you must learn how IRT design can influence the clinical supply lifecycle.
- Understand the impact of Protocol and IRT system designs on IMP supply capabilities
- Explore how to create efficient DTP experience for both the sites and patients
- Follow in-depth examples on how Protocol and IRT design influence the clinical trial lifecycle
Our facilitated Interactive Discussion Groups (IDGs) optimize peer-to-peer learning by crowdsourcing solutions to common challenges surrounding deploying and scaling DCTs. The connections you make through the IDGs will become your most valuable takeaways
- IDG 1: Stabilize Operations and Delivery in Decentralized Trials
- IDG 2: Tame Complexity in Decentralized Trials
- IDG 3: Uncover the Value of Decentralized Trials in Oncology
- IDG 4: Discuss the Remaining Barriers that Exist in Decentralized Trials Toda
In traditional clinical trials, the transportation barrier posed a significant challenge for rural patients lacking access to commuting options. Additionally, the rarity of certain diseases made it difficult to locate eligible patients for tailored clinical trials. DCTs present various solutions to these issues, which are essential for your team to understand.
- Evaluate how DCTs improve the clinical trial experience for rural patients
- Clarify how patients with rare diseases are more likely to participate in clinical trials
- Recognize how traditional clinical trials affect these specific populations
In traditional clinical trials, patient recruitment can be an overwhelming challenge. Increasing the diversity of your patient population can not only enrich data acquisition but also allow for the development of more effective products catered to a broader population. As of December 2022, the FDA now requires a diversity action plan for some clinical studies. Your team should realize how this new guidance affects many clinical trials, and how increasing diversity is key to optimizing data outcomes.
- Compare traditional clinical trials to DCTs in terms of patient recruitment and retention
- Examine case studies on how diversity impacts clinical trial results
- Ponder the implications of the updated FDA guidance in concern to diversity in clinical trials
According to Forte Research in 2023, the average drop-out rate for all clinical trials is 30% and the average cost to recruit a singular patient is $6,533. In a recent survey, 44% of study participants claimed that traveling to a study clinic was “burdensome,” and 40% said that the length of the visits was “burdensome.” These numbers point to the fact that patients tend to do studies that are more convenient for them. DCTs offer patient’s multiple options including remote or hybrid trial designs. Based on this, DCTs have become widely accepted in the current landscape because of the flexibility they offer patients.
- Analyze the financial and logistical implications of patient drop-out rates and recruitment
- Evaluate how patient burden in regard to travel and visit duration emphasizes the importance of convenience for patients
- Explore the role of DCTs in offering flexible options for the patient
Community-based clinical trials can improve patient equity by overcoming geographical, income, and other barriers. Your team should be able to explore how modern approaches can speed up the delivery of innovative therapies. Recent updates in regulations governing roles in decentralized clinical trials need further modernization to reflect current practices and advancements. Stakeholders have had time to implement changes in the FDA's DCT Draft Guidance, but questions remain. There are remaining issues, such as supervision requirements for sub-investigators, sponsor responsibilities in clinical trial functions, as well as many other challenges.
- Identify impacts and advancements made related to DCT capabilities
- Assess specific challenges and gaps related to implementation of FDA’s new DCT Guidance
- Discuss potential solutions to regulatory barriers
During COVID-19 there was a major push toward the implementation of DCTs since people were stuck in their homes without proper access to outside resources. Now that we are post-pandemic, DCTs are shifting from a “new topic” to a standard that should be included in every trial model. Your team should understand how integrating a decentralized elements into everyday clinical trials can enhance DCT outcomes.
- Debate whether DCT should still be referred to as “DCT” or if they should be fully integrated into traditional clinical trials
- Craft a blueprint for the future of clinical trials
- Discuss the advantages of adding decentralized elements to every clinical trial
As DCTs are becoming widely accepted as the new standard, site frustrations have become more commonplace. Some of these include lack of communication and technology integration, management challenges, and increased site costs. Your team should be prepared to assess these challenges and strategize how to deal with them.
- Explain the role that sites play during DCTs
- Consider the consequences of inadequate communication between sites and sponsors
- Deliberate on the strategies required to address these challenges
In order to have a successful clinical trial, the patient’s voice should be considered throughout the entire developmental journey. Patients are the key stakeholders and the focus for DCTs, so how can their voices be prioritized?
- Patient engagement is essential and to be most efficient, should be early, consistent, and meaningful.
- Examine how to allow for flexibility: Input (different methodologies) and output (protocol that, to the greatest extent possible, has flexible options)
- Consider how obtaining input and co-creating can benefit DCTs
