The pharmaceutical industry is actively interested in harnessing data that comes from wearables to create a comprehensive picture of a candidate's health during a study trial. Companies outside of the healthcare space such as tech vendors and healthcare startups, are paying close attention to the trial setting and helping to provide the tools necessary for using wearables in study trials. Wearables demonstrate potential to add value to clinical studies but challenges remain in protocol design, regulatory compliance and operations.
“How will we know it’s going to be accepted by regulators? and “As we devise endpoints of our choice, how can we provide evidence to show that the endpoint is valid and reliable for use in a clinical trial and regulatory submission?” The ePRO consortium and the wider clinical stakeholders are asking to understand how regulatory stakeholders will respond to these questions.
ISPOR (Value Health) has presented a framework regarding the selection and evaluation of wearable devices to address these questions. This is a good starting point to start the process of selecting and evaluating devices. Topics of this framework includes:
- Safety: Is the wearable device or sensor safe to use?
- Suitability: Are the device and vendor suitable for the trial objectives and patient population studied?
- Validated and reliable data: Is there satisfactory evidence of data validity and reliability to confirm that the device provides the required level of accuracy and precision in measuring the concept of interest?
Regulations around companion apps, which are applications displaying or transmitting data from a wearable, may not need clearance for use in clinical trials if they are designed to simply report data (Value Health). This framework provides a good assessment for the adoption of wearables in clinical trials, despite not having a published regulatory guidance addressing implementation at this current time.
Finessing clinical study design
Phase II and III are the most difficult phases of running a study but are also where wearables would be used. In these phases, two critical decisions are picking the endpoint and choosing the right patients. Clinicians must pick a short-term, measurable endpoint in a good amount of diversified patient population to be statistically significant enough via proof of concepts studies. This is where chosen wearables can track the necessary end points needed to make the data statistically significant, thus creating valuable insights.
Spending more time up-front on finessing the clinical trial protocol, with the right key stakeholders and technology partner is crucial. We know how important big data is, but it needs to be applied to the correct endpoints.
Steps to wearable adoption
- Design a small proof of concept study incorporating the framework above, to quickly gain knowledge of how to use wearables with an expert tech partner before incorporating it into a larger trial.
- Obtain a robust digital health platform to manage the data collected. With so much data involved during the clinical trial supply chain, especially if multiple wearables is used, it is critical that the data is managed efficiently and effectively.
- Demonstrate device security and reliability of remotely gathered data through encryption. Security is complex, but it is also critical. Success requires a thorough benefit–risk assessment by experts just like any other medical intervention.
If your organisation is looking to collect and make sense of data collected in wearables in clinical trials, check out expert insights and user stories to understand your clinical trial and wearable strategy.