Long Shot COVID-19 Treatment Yields Fast, Promising Results Using Decentralized Trial Approach
Planning Decentralized Trials
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.
CTTI Paper Reveals Investigator Perspectives on Advantages and Challenges of Digital Health Trials
Now more than ever, mobile technology is affecting every aspect of our lives, including the way we conduct clinical research. In a new preprint manuscript, CTTI examines the investigator experience in digital health trials.*
In-depth interviews conducted with 12 investigators representing an array of clinical specialties revealed the benefits and challenges of incorporating mobile technology into clinical trials through the use of smartphones, tablets, notebook computers, and wearable devices.
Some common benefits of digital health trials cited by the investigators include:
- Streamlined study operations and data collection
- Simplified and continuous study data capture throughout the trial
- Improved study and data quality and an increase of “real-world” results
The manuscript also details specific challenges investigators faced when using digital health technologies in trials. These include an increase in the amount of time needed by investigators and study personnel to review data and maintain the technology, additional training, technology adoption barriers for participants and staff, and uncertainty with data validity. These potential obstacles must be proactively addressed in order to harness the full benefits of digital health trials.
Learn more about CTTI’s Digital Health Trials work.
*CTTI’s Digital Health Trials work was previously called “Mobile Clinical Trials”.
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.