A hundred years ago (see radio news cover photo from April 1924), the concept of “decentralized care” seemed just around the corner. To achieve this, several key elements had to evolve over the past century. Sensors (remote patient monitoring), telecommunications infrastructure (Internet), science and, perhaps most importantly, buy-in from the medical and patient community. The COVID-19 pandemic has significantly accelerated the latter. What do we learn and how do we actually move forward?

Decentralized clinical trials (DCTs) are not new, depending on how they are defined. The concept and early testing of decentralized design took place well before COVID 19. About “Trials over the Internet” in 2007.

Recently, guidance from the Clinical Trials Transformation Initiative (CTTI) defined a DCT as a trial in which “some or all of the study assessments or visits are conducted at a location other than the investigator’s site.”Here, especially part In this broad spectrum: how technology enables participation, reduces participant burden and results in better data. We believe this aligns well with efforts to provide broader access to a more diverse population, encouraged by the latest FDA recommendations.

The advent of electronically collected data such as remote patient monitoring technologies, wearable sensors and ePROs has enabled pharmaceutical companies and CROs to conduct viable decentralized drug development trials, but the reality is that the more patient-centric Concentration as a result of global data. How these trials are established, conducted and validated has evolved significantly under the pressure of the COVID-19 pandemic. The question is what happens next. What can we learn (both pre- and post-COVID) and how can we put it into practice? Establishing benefits for participant burden and cohort diversity as well as safety and efficacy of new drugs How do you balance the hard endpoints you need to do? What research designs benefit all stakeholders, including patients, investigators, sponsors and society? Need elements, enabling technologies, and next-gen data management?

patient’s perspective

Starting with patient benefits, many aspects of clinical trials can be performed remotely. Done right, it improves usability, accessibility, and diversity. Medical-grade remote patient monitoring (RPM) devices and digital technology make it easy to obtain high-quality data, but converting this data into clinical trial endpoints is a daunting hurdle. Most importantly, the necessary foundation for regulatory approval and, ultimately, pharmaceutical industry buy-in must first be established.

As anyone who has spent hours in a wireless carrier’s digital “customer support loop” can attest, decentralized processes must be simple, effective and efficient to ensure patient compliance. must be We have heard from test subjects that although they are motivated, they are unable to participate in clinical trials due to the heavy burden of travel. Her DCT features such as RPM devices will allow you to participate. These medical devices (mainly wearables) must be designed with patient comfort, reusability, and self-service in mind. Depending on the trial, the participant pool may be tech-savvy millennials or older demographics who may be less tech-savvy and/or dependent on caregivers. As we seek to expand the diversity of participants in different studies, study participants are likely to represent a wide range of demographics.

The pandemic has forced some people to rapidly adapt to various forms of digital healthcare, including telemedicine. This is positive progress, but it is not enough. There is an opportunity to further leverage this adoption by facilitating participation in decentralized trials and expanding into previously underserved populations. Doing so means recognizing the problems and developing solutions to ensure that the progress achieved so far is not temporary and promotes more patient-centred drug development. To do.

Pharma’s Perspective

Both digital healthcare and pharmaceutical companies should look to apply wearable and digital technologies more carefully, rather than just throwing the technology at issue. There is a tension between patient burden and convenience, and the ability to collect the tough, statistically significant endpoints of safety and efficacy that are ultimately required for regulatory approval. An effective DCT requires the ability to remotely monitor patients and obtain accurate data that meets both clinical and FDA-approved endpoints.

One of the key advantages DCT can provide using technology is the ability to collect data in the “real world” in a biologically based rhythm.This requires rethinking how we have defined endpoints historically and looking at more Functionl Results that are more meaningful than point-in-time laboratory or physician-assessed results. As our understanding of individual differences and circadian variations deepens, the definition of “fever” is also changing. Obviously not all endpoints can be measured at home. As an example, no imaging or biopsy is done in someone’s living room.But what matters is the decision functional Endpoints can be obtained from patients performing daily activities that correlate with scan or biopsy results and provide a more detailed picture of disease trends.

Successful pilot implementations of DCT are not necessarily entirely hypothetical. We believe that a hybrid approach that combines remote functionality, convenient locations, and traditional methods will continue for the foreseeable future. Sleep is an illustrative case study. In-clinic sleep studies are said to be an accurate measure of how no one sleeps. The data are less subject-burdening, more representative, and can be run over time and night to establish patterns and derive analyzable data. In-clinic sleep studies can yield valuable insights using technology that cannot be easily deployed at home. Range change reflects efficacy as data on how and how much the patient is actually moving. When there is no doctor’s observation. That can be the difference between a singular and objective discovery and an evaluation of drug efficacy by the actual function of the subject. The ability to record continuous data provides a longitudinal view of the patient rather than snapshots. Rather than actually analyzing patient A and patient B for status and applicable trends, investigators can assess the progress of each subject as their own control patient. This new, richer and more objective data is only beneficial if we have the ability to properly structure and analyze different information streams to reap the benefits of a decentralized model.

possibility of change

Decentralized models require new approaches to trial endpoints. The recently issued draft FDA Guidance on Digital Health Technologies and RPMs for Clinical Investigations, among other things, calls for new endpoints to be justified and methods for assessing patient response to be “clear and credible.” says it must. This can pose problems for RPM and the data stream it produces. Those conducting research want to ensure that endpoints meet the necessary criteria for safety, efficacy, and approval.

Remote patient monitoring technology is an important tool for DCT. They contribute to the win-win-win in the proverbial eating cake, eating that too and not gaining extra pounds.

1. Reduce patient burden and increase access.
2. Better, objective data that connects clinical research to the real world.When
3. Inexpensive trials that enable faster recruitment, better retention, greater patient diversity, and more attempts to achieve desired goals.

The pandemic has provided a glimpse of what is possible when pharma, (medical) technology, CROs and regulators work together with a sense of urgency against a common threat. This spirit of cooperation must continue if urgent unmet medical needs are to be successfully addressed. This is the only way to develop clinical trials that are tailored, adapted to the patient and fit into the patient’s life, not the other way around.

Tony FantanaLead, Emerging Technology Strategy – Clinical Design, Delivery & Analysis, Eli Lilly and Company

Arthur Combs, MD is a clinician, serial entrepreneur and thought leader in wearable technology and digital biomarkers. He has consulted for many companies, especially those bringing new non-invasive or digital technologies to market.

Jean LeeFounder and CE, VivaLNK