A recent webinar from Medable discussed the steps it is taking to improve clinical trial design through decentralized clinical trials (DCT). The Covid-19 public health crisis has accelerated the adoption of DCTs. But life sciences companies are taking steps to increase the diversity of clinical trial hiring. Part of this work involves figuring out how to make people feel more comfortable making decisions about participation.
Key learning objectives of the webinar include:
- Best practices for addressing key delivery pain points in clinical trials using digital and home health solutions (including wearables/sensors/connected devices)
- How to use technology to achieve better patient representation in trials to meet new needs Diversity Equity Inclusion (DEI) Regulatory Guidance
- How to use best-in-class digital solutions to accelerate time-to-target while improving patient experience
- How to leverage the ability to capture evidence from health apps, decentralized trials, and digital endpoints connected by connected devices to help prevent and manage cardiovascular disease.
Team members include:
- MaryAnne Rizk, Chief Strategy Officer, Medable
- Claire Marsden, Vice President, DCT Solutions, Cardiovascular and Metabolic Disease, Medable
- Tammy D’Lugin-Monroe, Vice President, Global Therapeutic Strategy Innovation, Syneos Health
patient-centred
Rizk describes DCT as an opportunity to establish the highest level of patient-centricity, whether virtual or hybrid. D’Lugin-Monroe agreed, saying it was an effective way to bring clinical trials to participants.
“I think it’s an opportunity for us to look at the data more in real time, to see how patients are changing more quickly, rather than just relying on patients to interpret how they’re feeling and to have them at the point where they think it might be during their visit. deterioration in time. We now allow [principal] Researchers can learn more about patients in real time and avoid missing opportunities for potential endpoints.Decentralized trials have greatly improved our deliverability and confidence [in] The endpoints we submit to regulatory agencies…the faster our ability to improve meaningful, effective treatments for patients also means having a well-represented population. “
Adoption of Wearables and Sensor Technology
Sensors embedded in wearables and smartphones make DCT possible. The widespread adoption of these devices and the increasing ease of sharing these data simplifies patient participation in studies. Marsden observed the impact of the technology.
“At Medable, we’re leveraging medical-grade sensors, wearable technology and modern technology to really help remove all of these barriers and make it easy for patients to participate. It’s also expanding the network in terms of increasing the number and diversity of patients who can enroll. This helps We’re reaching new areas with high rates of cardiometabolic disease; we can now tap into these population pools because we’re making the trial process easier.”
Passive collection of patient data means researchers have access to data that can provide insights into disease triggers, disease progression, and can help them get measurements without impacting patients’ lives, Marsden noted.
Increase the diversity of clinical trial researchers
D’Lugin Monroe noted that having a diverse team of principal investigators can also make a big difference in increasing the diversity of clinical trial participants.
“Patients may trust people who look like them more and recommend that they participate in a particular study. This is what we’ve learned through multiple surveys, through Patient Pulse…when they click on the link [for the clinical trial], the landing page needs to look like them. We may have 8 to 10 different landing pages, depending on where the patient learns about the study and its demographics. “
tokenization
Another prominent topic of discussion was the regulatory environment and tokenization in the context of DCT.
“along with Descriptive method, FDA is asking sponsors to hold workshops to review and understand how to build diverse populations for clinical trials,” Rizk said. “We knew this was coming. It’s very encouraging to see us actively working together as partners. “
D’Lugin Monroe talks about the importance of tokenization.
“When we tag a patient, we are able to monitor that patient throughout the patient’s journey, during, and even after the study so that we can collect these longitudinal data. The long-term impact on the patient is very important. Tokenization allows us to access that data for years with the patient’s consent. So I was able to see if there was a change throughout the outcome study. If a patient showed up in an urgent care facility, they Have received a new inhaler and had to be treated with a nebulizer – if they don’t see their investigator, but every six months in a long-term study, they may forget about this follow-up. But as a sponsor’s Part of it, I don’t miss that information because they need to know the kind of changes that can happen during their participation in the study.”
Medable and Syneos Health seek to increase the diversity of trials by designing and delivering clinical trials that reduce the burden on participants, and by increasing the comfort of patients participating in clinical trials. The long-term benefits of doing so will mean more effective drugs and therapies for chronic diseases, leading to improved outcomes for a wider patient population.
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photo: Peter Pencil, Getty Images
