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

Key learning objectives for the webinar include:

• Best practices in the use of digital and home health solutions to solve for key delivery pain points in clinical trials (including wearables/sensors/connected devices)
• How to leverage technology to achieve better patient representation in trials to meet the requirement of new Diversity Equity Inclusion (DEI) regulatory guidance
• How to accelerate time to target endpoint while improving the patient experience using best-in-class digital solutions
• How to leverage the ability to capture evidence that’s supported through digital endpoints connected from health applications, from a decentralized trial, as well as connected devices, to help with the prevention and management of 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 Therapeutic Strategy Innovation, Syneos Health

Patient centricity

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

“I think for us, it’s been an opportunity to see data more in real time, observe patient changes more quickly and not rely solely on the patient to interpret how they’re feeling and having them contact an investigator when they think maybe they’re deteriorating in between their visits. We’re allowing now for [principal] investigators to see more in real time, what is happening with their patient and avoiding opportunities for missing potential endpoints. Decentralized trials have made a massive improvement in our ability to deliver and have more confidence [in] the endpoints that we’re presenting to the regulatory authorities….The ability for us to improve meaningful, effective therapies for patients faster also means having a well-represented population.”

Wearable devices and sensor tech adoption

The sensors embedded in wearable devices and smartphones make DCTs possible. The widespread adoption of these devices and the increasing ease in which this data can be shared simplify study participation for patients. Marsden observed the impact this tech has had.

“At Medable we utilize medical grade sensors, wearable technology, modern technology to really help cut through all of those barriers to a patient being able to participate easily. It’s also widening the net in terms of increasing the number and diversity of patients that can enroll. This helps us touch new geographies where there are a high prevalence of cardiometabolic disease; we can now tap into those population pools because we’re making the trial journey much simpler.”

Marsden notes that the passive collection of patient data means that investigators have access to data that can provide insight on disease triggers, disease progression, and can help them to obtain measurements without disrupting patients’ lives.

Increasing diversity among clinical trial investigators

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

“Patients are going to likely be more trusting of someone who looks like them and is recommending them to participate in a particular study. This is something that we have learned through multiple surveys, through Patient Pulse…When they click on a link [for the clinical trial], the landing page needs to look like them. We may have anywhere from eight to 10 different landing pages based on where a patient may learn about the study and their demographics.”

Tokenization

Another prominent theme of the discussion is the regulatory landscape and tokenization in the context of DCT.

“With the DEPICT Act, the FDA is requiring a workshop for sponsors to review and understand how to build a diverse population for the clinical trial,” says Rizk. “We know this is coming. It’s very encouraging to see as partners that we’re working actively together.”

D’Lugin Monroe spoke to the importance of tokenization.

“When we tokenize a patient, we’re able then to monitor that patient through their journey, during, and even after a study so that we’re gathering this longitudinal data. That’s very important for how we develop our clinical trials in the future and also towards understanding the long-term effects of a particular treatment that we’re studying on a patient. Tokenization allows us to access that data with the consent of the patient for many years. So I’m able to see, throughout the course of an outcome study, if something changed. If a patient shows up at an urgent care facility, they’ve received a new inhaler and had to have a nebulizer treatment — this is something that they may forget if they’re not seeing their investigator but every six months in a long term study follow-up. But I’m not going to miss that information as part of a sponsor needing to know that type of change that may have occurred during their participation in a study.”

By designing and delivering clinical trials that reduce participants’ burden and by increasing patients’ comfort level with taking part in clinical trials, Medable and Syneos Health seek to increase diversity of trials. The long term benefits of doing so will mean more effective drugs and therapies for chronic conditions that improve outcomes across a wider patient population.

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Photo: PeterPencil, Getty Images