Decentralized Trials
CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations
The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Aug. 25-26 to discuss best practices on conducting research in remote and virtual settings, including lessons learned from the COVID-19 pandemic. The insights gathered will be used to refresh CTTI’s 2018 Decentralized Clinical Trials (DCT) recommendations and ensure that they offer the most current information for planning and operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping).
During the meeting, relevant experts and key stakeholders—including investigators, patients, regulators, technology experts, sponsor representatives, and other groups—CTTI and attendees exchanged knowledge, insights, and current solutions for using DCT solutions in clinical trials.
They also identified some important themes and identified opportunities to increase adoption of DCT solutions moving forward:
- Design with Purpose. The design of DCTs must prioritize patient safety and data quality. DCT elements should only be incorporated into study design where they are appropriate to the purpose of the study.
- Engage Everyone. It’s important to engage all stakeholders in DCT protocol design and implementation.
- Think Ahead, Early On. Careful planning and consideration from the earliest stages of study and program design is essential.
- Invest in Quality. DCTs are often not the cheapest or easiest solution, but they can be the most impactful in terms of making trials more patient-centered and getting the best data.
- Where to Focus Next. Communication, collaboration, and regulatory guidance are critical for broader adoption of DCT solutions.
CTTI is now updating its recommendations and will make them available by early 2022 to help accelerate the adoption of DCT solutions in clinical trials going forward.
CTTI Updates DCT Recommendations in Response to COVID-19
COVID-19 forced the clinical trials ecosystem to plan and conduct research in remote or virtual settings. In an effort to support this shift, CTTI is launching a project to update its Decentralized Clinical Trials (DCT) recommendations to ensure they reflect the latest learnings and emerging best practices from the pandemic.
CTTI’s current DCT recommendations, which launched in 2018 and focus on the use of telemedicine, mobile and local healthcare providers, and related topics, were the most frequently downloaded document on CTTI’s website in 2020, reflecting the increased demand for decentralized solutions in times of COVID-19.
This new project aims to support the accelerating adoption of DCT solutions in clinical trials going forward. The updated recommendations will focus on selecting and operationalizing DCT solutions, ensuring effective safety monitoring, and appreciating the needs and perspectives of investigators, sites, and participants.
This effort builds on CTTI’s initial recognition that running a DCT does not have to be all or nothing. DCTs can be completely virtual, but many will be partially decentralized using a hybrid approach. Regardless of where a trial falls on the decentralized continuum, it is always important to:
- Plan ahead as much as possible
- Involve all stakeholders early and often
- Focus on what matters
- Communicate and be transparent
Sponsors and CROs can use the revised recommendations to design a fit-for-purpose, efficient DCT—one that can reduce patient burden, improve enrollment, and more closely replicate real-world populations and scenarios.
New CTTI Publication Maps the Road Ahead for Decentralized Clinical Trials
A peer-reviewed article highlighting CTTI recommendations for Decentralized Clinical Trials (DCTs) was published this month in Therapeutic Innovation and Regulatory Science. The article describes the process of identifying and addressing the legal, regulatory, and practical hurdles for planning and conducting DCTs.
DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment, improved retention, greater control and convenience for participants, and increased participant diversity. CTTI’s evidence-based and practical recommendations address roadblocks that could be hindering the widespread use of DCTs.
The article covers recommendations about trial design and conduct, telemedicine state licensing, medical product supply chain, mobile health care providers, investigator delegation and oversight, and safety monitoring that can help the industry navigate real and perceived barriers in the road to greater adoption.
New CTTI Recommendations Offer Path Forward for Decentralized Clinical Trials
CTTI released new recommendations on overcoming the legal, regulatory, and practical hurdles for planning and conducting decentralized clinical trials (DCTs) today during the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass.
DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment, improved retention, greater control and convenience for participants, and increased participant diversity. CTTI’s evidence-based and practical recommendations address barriers—including varying state medical licensing laws and issues with the drug supply chain of custody—that could be hindering the widespread use of DCTs.
The recommendations also offer guidance on effective DCT protocol design, investigator delegation and oversight, use of mobile health care providers, and safety monitoring. A key concept within the recommendations is that DCTs do not have to be fully decentralized, but can incorporate various procedures and activities that are common in traditional studies.
This is the third set of recommendations from CTTI’s Mobile Clinical Trials Program for FDA-regulated trials, which aims to drive the adoption of mobile technologies in an effort to improve the efficiency and quality of clinical trials. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in July, it unveiled new solutions for using mobile technologies for data capture in clinical trials. Recommendations addressing patient and investigator engagement regarding the use of mobile technologies in clinical trials will be released in early 2019.