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Decentralized Clinical Investigations – a Realistic Option for Medical Device Sponsors?

Decentralized Clinical Investigations - a Realistic Option for Medical Device Sponsors?

This is a blog written by Elemed expert guest blogger Jón Ingi Bergsteinsson. Want to be a guest blogger? Email [email protected] for more info!

Decentralized clinical trials have turned into a great buzz in the life science industry. With the COVID-19 pandemic halting clinical trials around the world, sponsors have been forced to re-evaluate their clinical operations. But are decentralized clinical investigations the future standard for Medical Device clinical operations – or is it just a buzz?

For years, healthcare providers have dreamt of using information and tele-technology to offer healthcare services remotely, to improve outcomes and reduce cost. Clinical investigations are no different. In recent years, clinical service providers have started to promote the concept of decentralized clinical investigations as a way to improve efficiency and reduce the cost of clinical operations for sponsors.

During the COVID-19 pandemic, many of these service providers started promoting the concept as a business continuity solution – which was mainly addressed at reducing on-site visits, and keep studies running “remotely”. But the concept of decentralized clinical investigations is not only about limiting on-site visits.

In order to address the headline question, we need to understand the concept and what it means for sponsors and patients.

What are Decentralized Clinical Investigations?

Traditionally, clinical investigations are centered around clinical sites, where clinical investigators recruit study subjects and collect data. The concept of decentralisation is completely the opposite of that, where the patient (or subject) is placed at the center of the investigation and not the clinical site or investigator.

The idea is borrowed from political ideology, where the concept of decentralisation is all about distributing or delegating planning and decision making away from a central authority.

However, if one is to decentralize a clinical investigation, leaving planning and decision making in the hands of the patient might not be wise. Instead, the idea is to execute the plan around the patient and his interests. This includes e.g.

    • Bringing study recruitment closer to patients, to enable more people to participate in relevant research studies.
    • Improving transparency of the patient’s own participation, to motivate and empower patients – in the hope of increasing adherence and compliance.
    • Reducing on-site visits to minimize interference with the patient’s day-to-day life, and minimize resource needs at sites.
    • Enabling patients to be in control of when (and sometimes how) to report clinical outcomes, e.g from the comfort of their own home using their own devices.
    • Increasing focus on patients’ participation, which is mirrored in high-quality support, communication and information sharing.

As a result, study design tends to be based on remote consultations and data capture through virtual visits. But people often confuse the definition of decentralized investigations with remote study designs.
To clarify, industry peers have categorized decentralized clinical investigations into two groups, i.e. hybrid and virtual (remote) designs.

Hybrid clinical trial design
Image presented with permission from Studies&Me

Hybrid study design includes at least one on-site visit while other activities are usually completed remotely, e.g. using smart devices and conference calls. However, if the patient does not have to participate in any on-site visit and everything can be handled remotely, it’s categorized as a fully remote (or virtual) study design.

Virtual decentralized clinical trial design
Image presented with permission from Studies&Me

Is decentralization the future of clinical operations?

With heightened requirements on clinical evaluation and clinical data under the European Union Medical Device Regulation (MDR), medical device manufacturers are pacing to redesign their clinical strategy. This includes addressing how clinical investigations are conducted and how data is collected.

The increased focus on clinical data will greatly impact budgets and resources, especially for those who have never conducted clinical investigations before. It’s therefore essential for those manufacturers who are initiating clinical investigation, that they do so efficiently and effectively.

The EU MDR together with the COVID-19 pandemic will probably encourage manufacturers to seriously evaluate the option of conducting more decentralized investigations.

But even though more and more pharmaceutical companies might see decentralized design as a viable option for future trials, it might not be as attractive or feasible for many medical device manufacturers.

Decentralized clinical investigations could help sponsors to reduce cost and increase compliance, but its application for medical devices depends on a range of factors, such as

    • Whether it’s clinically feasible or relevant for the device in question
    • Is the value driver large enough (cost, compliance or data wise)?
    • The cost of technology and service to support a decentralized design.

The concept of decentralization is sparking a lot of interest amongst clinical operation experts, but it might be impossible, or unuseful, to apply the concept to all types of studies.

Medical devices are different

While pharmaceutical trials are often similar in design, device studies can be very different from one device to another. Here I am not referring to clinical endpoints or statistical testing, but rather the difference in how devices and medicine are applied in clinical practice.

Medical devices are used by clinical staff all around the world on a daily basis. Other times, it’s the patient himself who’s the primary decision maker and user. But for pharmaceutical products, the application in the treatment pathway is usually always the same, i.e. the patient is administered medicine, and the clinical expert acts as an observer. The difference in application, and use in clinical practice, is what sets pharmaceutical and device studies apart.

As mentioned before, the goal of decentralization is to move the decision making, execution, and responsibility away from clinical sites and closer towards the patients. In some cases, this might not be feasible, or of interest, to a medical device manufacturer. Mainly because of the nature of these devices and how they are used in practice. For example, investigations on diagnostic- or procedure-related devices, such as scanners, scopes or catheters, might not benefit from decentralization. Because its application always requires clinicians to be in control of its application in practice.

With that said, the same argument could still be used for some medicinal products, e.g. products that are never administered by the patient himself.

Hence, there are multiple cases of both pharmaceutical products and medical devices, where decentralized clinical investigations might not provide benefits to the sponsor or patient.

Opportunity for some medical device manufacturers

Sponsors that have a device that could be included in a decentralized clinical investigation, should seriously evaluate the possibility. Not only because of the potential positive impact on recruitment, data quality, cost, or compliance. But also because the competition among service providers and the technology to support the concept, has greatly improved during the COVID-19 pandemic.

But even though the industry and patients might be showing more interest in the concept, there are still national legislations that prohibit sponsors in conducting fully remote (virtual) decentralized clinical investigations, where informed consents need to be completed via on-site visits.

With rapid improvement in eConsent technology and more secure electronic identification, we might see this change for the better in the next few years.

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About the author

Jón Ingi Bergsteinsson

co-founder and VP of Global BD at SMART-TRIAL

Jón Ingi Bergsteinsson, M.Sc. in Biomedical Engineering, is the VP of Global Business Development at SMART-TRIAL, where he helps MedTech companies to bridge the gap between their devices and clinical data. As the co-founder of SMART-TRIAL he previously served as the CTO from 2013 to 2017, where he paved the way for the platform’s quality standards, data security, and compliance. With a strong technical background, and 10 years of experience in clinical investigations, eClinical software, and medical devices, Jón is mostly occupied with sharing valuable insights and know-how on clinical data collection with the MedTech industry.

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