CTTI maps novel endpoints to accelerate mobile tech use in clinical trials
Annemarie Forrest, RN, MS, MPH, associate director of projects at CTTI said the recommendations fall into two major buckets: optimizing novel endpoint selection and approaching the novel endpoint development process practically.
According to Forrest, the benefits of developing novel endpoints include reduced participation burden on both the patient and caregiver and improved predictability rates for advancement from Phase II to Phase III trials.
Additionally, developing novel endpoints increases the number of clinical trials that yield more complete information on how therapies affect disease aspects important to patients, she told us.
Key recommendations
Optimize novel endpoint selection
- Focus on measures that are meaningful to patients
- Select the device after selecting an outcome assessment
- Use a systematic approach to identify key novel endpoints
Approach novel endpoint development process practically
- Foster collaboration among key stakeholders
- Engage regulators throughout the development process
- Create technical standards for mobile technology-derived assessments
- Include novel endpoints as exploratory endpoints in existing clinical trials and observational cohort studies
- Critically position novel endpoints in interventional trials
A multi-stakeholder project team, including regulators, sponsors, investigators, patient representatives and technical experts, developed the recommendations, which are based on evidence gathered throughout the project.
“These recommendations and tools provide stakeholders with not only the ‘so what’ but also the practical steps by which to develop novel endpoints using technology-derived endpoints,” Forrest explained.
“We heard loud and clear from key informants when we were developing the project that this was an unmet need, so we haven’t been too surprised that initial feedback has been extremely positive,” she added.
Mobile clinical trials
In addition to releasing the recommendations, CTTI has also launched a Mobile Clinical Trials Program. “We know that development of novel endpoints is just one hurdle organizations face when considering how to appropriately incorporate mobile technology into clinical trials,” said Forrest.
Subsequently, as part of this program, other projects are addressing legal and regulatory issues, patient and provider perceptions, and scientific and technological issues related to mobile technology use in clinical trials.
“These projects are working to gather evidence now and will release recommendations and tools over the course of the next 6-12 months,” explained Forrest.
“We’re excited for not only the individual recommendations and tools these projects will produce, but for the opportunity to eventually put all the pieces together and provide end to end support to advance use of mobile technology in clinical trials.”
