Improving health equity through decentralized clinical trials

A recent Medable webinar discussed the steps it is taking to improve clinical trial design through decentralized clinical trials (DCTs). The Covid-19 health crisis has accelerated the adoption of DCT. But life science companies are taking steps to increase diversity in clinical trial recruitment. Part of that effort is figuring out how to make people feel more comfortable about making the decision to participate.

The main learning objectives of the webinar include:

  • Best practices in using digital and home health solutions to address key delivery issues in clinical trials (including wearables/sensors/connected devices)
  • How to leverage technology to achieve better patient representation in trials to meet the demands of new Diversity Equity Inclusion (DEI) Regulatory Guidance
  • How to accelerate time to target endpoint while improving patient experience using best-in-class digital solutions
  • How to leverage the ability to capture evidence supported by connected digital endpoints from health apps, decentralized trial, as well as connected devices, to aid in prevention and management cardiovascular diseases.

Among the panelists are:

  • MaryAnne Rizk, Chief Strategy Officer, Medable
  • Claire Marsden, Vice President, DCT Solutions, Cardiovascular and Metabolic Disorders, Medable
  • Tammy D’Lugin-Monroe, Vice President, Global Head of Therapeutic Strategy Innovation, Syneos Health

patient centered

Rizk described DCTs as an opportunity to establish the highest level of patient-centricity, both virtual and hybrid. D’Lugin-Monroe agreed and said it was an effective way to bring the clinical trial to participants.

“I think for us it’s been an opportunity to see data more in real time, see patient changes more quickly, and not just rely on the patient to interpret what they’re feeling and have an investigator contacted when they think it may be deteriorating between their visits.We now allow for [principal] investigators to see more in real time what is happening with their patient and avoid opportunities to miss potential endpoints. Decentralized trials have dramatically improved our ability to deliver and have more confidence [in] the metrics we present to regulatory authorities… The ability for us to more quickly improve meaningful and effective therapies for patients also means having a well-represented population.

Wearable devices and adoption of sensor technology

Sensors embedded in wearables and smartphones make DCTs possible. The widespread adoption of these devices and the increasing ease with which this data can be shared is simplifying patient participation in the study. Marsden has seen the impact of this technology.

“At Medable, we use medical-grade sensors, wearable technology, modern technology to really help overcome all of those barriers that prevent a patient from easily participating. It also widens the net in terms of increasing the number and diversity of patients who can enroll. This helps us reach new geographies where the prevalence of cardiometabolic diseases is high; we can now tap into those pools of people because we’re making the test run a lot simpler.

Marsden notes that collecting patient data passively means that investigators have access to data that can provide information about disease triggers, disease progression, and can help them get measurements without disrupting patients’ lives. patients.

Increase diversity among clinical trial investigators

Having a diverse team of principal investigators can also make a significant difference in improving the diversity of participants in clinical trials, notes D’Lugin Monroe.

“Patients are more likely to trust someone who looks like them and recommends them to participate in a particular study. This is something we learned through multiple surveys, via Patient Pulse… When they click on a link [for the clinical trial], the landing page should look like them. We can have between eight and ten different landing pages depending on where a patient can learn more about the study and their demographics. »

Tokenization

Another important topic of discussion is the regulatory landscape and tokenization in the context of DCT.

“With the DEPICT Act, the FDA requires a workshop for sponsors to review and understand how to build a diverse population for the clinical trial,” says Rizk. “We know it happens. It is very encouraging to see as partners that we are actively working together.

D’Lugin Monroe spoke about the importance of tokenization.

“When we symbolize a patient, we are able to follow that patient throughout their journey, during and even after a study in order to collect this longitudinal data. This is very important for how we develop our clinical trials in the future and also for understanding the long-term effects of a particular treatment that we are studying on a patient. Tokenization allows us to access this data with patient consent for many years. So I’m able to see, throughout an outcome study, if anything has changed. If a patient presents to an urgent care facility, they have been given a new inhaler and had to undergo nebulizer therapy – this is something they can forget if they don’t see their investigator but all the six months in a long-term study follow. But I’m not going to miss this information as part of a sponsor who needs to know about this type of change that may have occurred while participating in a study.

By designing and conducting clinical trials that reduce participant burden and increase patient comfort levels in participating in clinical trials, Medable and Syneos Health seek to increase trial diversity. The long-term benefits of this will result in more effective drugs and therapies for chronic diseases that improve outcomes across a broader patient population.

Fill out the form to watch the webinar.

Photo: Peter Crayon, Getty Images

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