SCOPE (Summit for Clinical Ops Executives) 2019, which took place in Orlando in late February, was another resounding success with a record attendance of more than 2000 participants. At XClinical (part of EvidentIQ), we had a busy four days of attending the different keynotes and breakout discussions and meeting with customers and visitors at our booth.
Topics this year ranged from data strategy and analytics, artificial intelligence (AI), clinical biomarker strategy, risk-based monitoring, and patient engagement, recruitment, and retention.
Of particular interest were the sessions on the use of technology, such as sensors and wearables, and its role in enabling patient-centric clinical trials.
Sensors on wearable devices now enable remote monitoring of a variety of different parameters, including activity such as gait and balance, body temperature, cardiovascular parameters, and blood oxygen saturation.
For those of you who weren’t able to attend, we’ve put together a summary of the key points to come out of these sessions.
Data Collection and Analysis, Patient Recruitment
Luis Garcia-Gancedo, PhD, Director, Clinical Sensors and Data Analytics, GlaxoSmithKline, discussed how sensors and wearables can make trials more patient-centric in a number of ways, both short- and long-term:
- Lower the barrier for trial participation because patients (and caregivers) don’t have to physically travel to assessment sites
- Provide more complete information on how therapies affect aspects of disease, as well as on the endpoints that matter to patients
- Ability to run more inclusive and generalized trials
Garcia-Gancedo also provided an overview of a biotelemetry platform that was used successfully to collect ALS patient data remotely. The platform was used to measure disease progression and its change over time as an endpoint.
This platform generated new insight into the lives of patients with ALS. However, a lot of data was missing, which limited the ability to draw conclusions. According to Garcia-Gancedo, if wearables are to be successfully used in clinical trials, innovative methods of data analysis are required.
This underlines the need to be mindful of the data privacy and security requirements that come with generating large amounts of raw and unstructured data.
FDA’s View on Wearables and Digital Endpoints in Clinical Trials
Kelley Erb, Ph.D., Director, Digital Medicine, Early Clinical Development, Pfizer, talked about the company’s efforts to develop and validate novel outcomes for Parkinson’s disease using sensors and wearables. When Pfizer met with the FDA to discuss this approach, the agency suggested that Pfizer use wearables to generate new clinical information rather than trying to measure traditional outcomes.
One other important recommendation from the FDA was to meet with The Center for Devices and Radiological Health (CDRH) to evaluate aspects such as:
- Device design
- Data processing
- Methods of data transmission
- Device output
This reflects the fact that while wearables have been developed as prototypes, there are very few approved and standardized currently being used in clinical trials.
Patient-Centric, Smart Trials
Jyoti Shah, Associate Director, Data Development, Merck, explained how the use of digital health technologies such as wearables could help organizations shift from a site-centric approach where the patient has to come to the trial, to a patient-centric approach, which brings the trial to the patient. This reduces the costs of the trial, as well as the skill set needed to carry outpatient evaluations.
In terms of digital biomarkers, wearables could be used to report the outcome remotely through the device rather the patient reporting it themselves. Two applications of this are in smart dosing and smart sampling.
Shah explained how the discovery of non-compliant subjects who had missed doses or dosed outside of the window in a clinical study showed the importance of collecting data in this way. The use of smart packaging and eDiaries as a way of collecting patient data was popular among study participants as they made it easier to share information.
Technology Underpinning Patient-Centric Trials
Munther Baara, MS, Head, New Clinical Paradigm, Pfizer talked about how implementing different patient touchpoints – such as sensors, in-home visit, ePro, and eConsent – helps improve patient retention and compliance in trials. It also enables more continuous, in-depth data capture, which improves the disease state characterization.
Baara explained that having a single patient data hub harmonizes, simplifies, and centralizes interactions across these touchpoints to reduce the burden on trial sites, as well as enable them to take advantage of the opportunities offered by sensors and wearables, as well as other digital technologies.
Our major takeaway is that to move forward with the use of these digital technologies such as wearable devices in clinical trials, technology vendors need to adopt more stringent standards, processes, and systems. These need to be fit for the purpose of keeping patient data safe and secure while improving the patient experience and creating patient-centric trials.
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