DECENTRALIZED CLINICAL TRIALS

Why Decentralisation Is The Future Of Clinical Trials

Decentralisation of clinical trials has been a growing topic of discussion and development over the last few years, enabled further by the advancement of available technologies.

What Is A Decentralised Clinical Trial?

Making clinical trials easier for patients by reducing or eliminating the need to travel to specific sites that includes virtual, home, remote, and siteless.?This approach has been shown to reduce drop-out rates, increase study effectiveness, and ultimately get life-altering drugs to market faster – saving sponsors billions.?

Patient-centricity” has been an industry buzzword for many years. We understand that reducing the required time and cost it takes to participate in clinical trials eases the burden on participants and delivers higher retention rates and efficiency.?In this way, decentralisation might be considered the epitome of a patient-focused approach to clinical trial design.

Why Is The Health Industry Reluctant To Embrace Decentralisation?

Challenges or barriers that sponsors may face when it comes to trial decentralisation are:

·??????Finding new technology vendors?and approving them in a timely way so as not to delay trials

·??????Finding specially-trained couriers?who are able to deliver medication and other medical supplies and equipment safely and legally

·??????Managing and processing a higher volume of patient data?received via apps and wearables

·??????Continuity of patient care?– inconsistency of visiting HCPs could potentially be distressing for elderly or neurodiverse patients, as well as those participating in trials related to serious diseases

·??????Time management?– where HCPs are required to visit multiple patients in one day, they will need to travel between locations efficiently and on time while maintaining the high standard of care they would deliver on-site

·??????Technological failure?resulting in a loss of patient data, as there will be no expert on hand to provide immediate guidance or fixes. This may disrupt or delay the trial progression by corrupting results.

·??????Patient attitude?— some patients may be more comfortable being seen in person, especially where they are unsure about administering tests or using technology. This may especially be the case for the elderly, or those participating in a trial for the first time.

The Main Benefits Of Decentralised Clinical Trials:

Decentralisation has the primary goal of making clinical trial participation as easy as possible, enabling participants to continue with their day-to-day lives with minimal disruption. Studies have revealed:

·?????70% of patients live more than two hours from a research site.

·?????In 50% of clinical trials, participants find it difficult to stay enrolled due to poor health.

·?????85% of trials fail to retain enough patients.

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Fully decentralised or hybrid (a mix of site and home-based activities) clinical trials have huge potential to positively impact clinical trial development in numerous ways, including:

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·?????Accelerating patient recruitment by making it easier to find potential participants (for example, in rural areas where travel to/from sites is difficult). More patients would be able and willing to take part if participation is easier, reducing the recruitment burden on CROs and sponsors.

·?????Increasing participant diversity by enabling patient recruitment from a much wider pool rather than limited to those within a reasonable distance of a participating site. This especially benefits rare disease research, where clinical trials are often “competing” for the same limited pool of participants.

·?????Patients become more knowledgeable, informed and engaged as a result of autonomy enabled by technology. There is a wide body of evidence suggesting engaged patients complete tasks such as electronic diaries with more accuracy and honesty. Electronic records can also be automatically time-stamped and verified as required.

·?????Gathering more diverse and applicable data sets by monitoring patients remotely in real-time. Furthermore, collecting data from a real-world setting is more likely to deliver insight free from the bias which results from undergoing assessments in a clinical setting.

·?????Improved reliability and accuracy of data – whilst paper can be lost or damaged or forms can be inaccurately filled out, collecting data using technology such as wearables, apps, and smartphones keep data organised and safe.

·?????Easier reporting and analysis of results as technologies enable data collection and sharing to be standardised

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Key Considerations For A Successful Decentralised Trial:

A cost-benefit analysis will also be required, to be sure that investment in alternative solutions will be beneficial in the long term. Some key points for consideration at this stage are:

·??????Will decentralisation of these elements significantly reduce the burden on patients, and therefore?improve retention?and?reduce the trial’s overall cost?

·??????Will reducing site visits?accelerate timelines?by allowing us to gather data faster?

·??????Will changes to processes?reduce workload?for clinical trial sites, resulting in time and cost efficiencies?

The most common areas for consideration when designing decentralised trials are:

·??????Communication with patients:?Where can use of smartphones and tablets improve and enhance patient communication and better facilitate data sharing?

·??????Travel reduction or elimination:?Even if some patient travel is essential, are there any site visits that can be eliminated in order to reduce the burden on patients?

·??????Technology-enabled data collection:?Where can wearable technology or patients’ existing devices be used to collect real-world data in real-time? Would this have the added benefit of eliminating transcription errors, or enhancing security??

·??????Home healthcare:?Would having a fully qualified HCP visiting patients in their homes to administer medication, perform tests, or obtain samples allow the trial to progress without a site visit?

·??????Transportation of medications, ancillaries and samples: Could a specially-trained courier transport medication, ancillary supplies or samples (including those requiring temperature control), collect unused medications, and deliver new medications?

When it comes to considering the trial as a whole, there are three core tenets to abide by:

·??????Accessibility?– use technology that’s easy to use and intuitive to learn. Technology is most effective in clinical trials when it fits seamlessly into patients’ daily routines and is accessible on devices they already have and are familiar with.

·??????Simplicity?– keep tasks for patients as simple as possible. If what’s required of them is too complex, this not only causes stress but it can also impact the integrity of results as there is more chance of error.?

·??????Reliability?– make sure your tools and processes have been thoroughly tested and that you’re aware of any potential pitfalls requiring mitigation. As the trial progresses, use patient feedback to continually improve your processes and increase reliability.

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