Decentralised Clinical Trials

Concierge services are critical to helping patients navigate technology and other logistics in a decentralised clinical trial. How best can they be implemented?

Laney Preheim at ICON

With the rising cost of bringing new drugs to market, sponsors are naturally looking for ways to get quality data quicker, to gain market access and reimbursement faster. Decentralised clinical trials have the potential to deliver this, and more. While many sponsors were already piloting or using selected decentralised service components – such as remote monitoring – before the pandemic, the need to keep trials on track provided the stimulus to increase the use of decentralised models. The focus on implementing these types of trials has never been greater.

According to research carried out by Industry Standard Research (ISR) in July 2021, 83% of respondents expect that the hybrid trial model will be used more frequently than the traditional model in three years’ time, with 63% reporting a positive experience of deploying decentralised trial components (1). The data and industry discussion are suggesting that decentralised clinical trials are here to stay. It is a significant – and positive – shift for the industry.

However, as with any significant shift, there are going to be challenges. Think back to the adoption of electronic data capture systems, and how the industry and sponsors had to evolve their thinking and operational delivery. It’s not just about the technology, although that was stated in the ISR report as a key challenge. Moving patient visits outside the traditional clinic or hospital setting, and using remote digital monitoring, comes with risks as well as benefits.

So how can sponsors deploy decentralised clinical trials, reap benefits including increased patient recruitment, retention, and diversity, in addition to the delivery of high-quality data, all while making it easier for patients to participate?

In working with sponsors, we highlight a number of factors that are important to the success of any decentralised or hybrid clinical trial to ensure these benefits are realised. Understanding the patient burden – afeature of every trial – is hugely important to determine the support they will need. And of course, fundamental to any clinical trial is maintaining patient safety. In a decentralised model, this means that appropriate checks are in place so that patient safety is not compromised.

Staying close to the patient underpins these two factors. At ICON, we do this by engaging the patient through our dedicated decentralised Concierge Services, providing support throughout the various stages of the patient’s journey in all phases.

Here, we explore the value that these support services can bring to studies, and why it is so critical to the success of decentralised and hybrid clinical trials.

As no two studies are the same, the patient support required will vary from study to study. Typically, sponsors want to ensure that the trial is patient-centric but do not always know how to develop and deploy these strategies.

Sitting down with the sponsor to discuss their specific study objective and trial characteristics enables us to identify the potential barriers in keeping the patient engaged, and to develop bespoke programmes that meet the challenges of the study.

Decentralised clinical trials are implemented in a spectrum of decentralisation, spanning light hybrid to fully decentralised. They can require a higher level of coordination and oversight, including increased support to patients to ensure their experience is smooth.

While moving some – or all – study visits can ease the travel burden, it can also introduce situations where patients may get stuck, and it’s important not to replace one burden with another. A concierge and direct-to-patient contact team will connect and guide them through these challenges to deliver a positive experience, improving patient engagement, compliance, and retention.

Employing a team that has the expertise and understanding to fully support digital platforms, hardware peripherals, and wearables that a patient may be using as part of their DCT, is important.

However, ‘tech support’ is not the real value that these premium patient services provide: it is the coordination activities, oversight of patient progress, and all the touchpoints that the patients need to keep things moving as part of the trial.

These teams can offer full device logistics management to further optimise the patient experience. Support services can also incorporate procuring, preparing, provisioning, and shipping devices (phones, wearables, vital sign measurement devices, and other biometric sensors) directly to patients, to enhance their experience.

Overall, it is important to avoid shifting clinical trial participation burden to the patient or the site, but rather put in place multi-channel specialised support for both patients and sites to ease the burden. Without such services, sites will be left to struggle with vendor management, learning new technologies, and assisting patients with a myriad of topics unrelated to clinical oversight, leaving both the patient and site staff feeling frustrated.

To deliver a decentralised programme successfully, we know technology is a key enabler, but it is not the full solution. Decentralised clinical trial implementations are only successful when direct-to-patient services have been curated specifically for, and optimised to support, the characteristics of the study. It is only when the right technology solutions are coupled with full concierge and logistics services that these models become a truly patient-centric experience.

This patient support is best explained by looking at the patient journey.

One of the ways these services might start the support journey during a trial is by reaching out to a patient, after screening, to schedule visits – telehealth, site visits, or a combination. This support will include the downloading of digital study apps (eDiaries, ePROs etc.) if they are using their own mobile devices.

If a mobile device is sent to the patient, once they receive their device, an outbound call welcoming the patient into the study will be placed, walking them through logging into the digital study app, setting up, and making sure the patient understands how to use the technology, and ensuring information is being transmitted correctly. At this time, the coordinator will review the study instructions with the patient, investigational product delivery, and go over dosage instructions.

When the patient has everything they need to begin their study, the service shifts into a monitoring and oversight phase. For example, if a study requires patients to do daily eDiaries on their medication adherence, the coordinator will review the entire study population, and perform outreach to those who have missed their eDiary entries, assisting them with any issues that have arisen.

In this monitoring and oversight phase, anomalies in reporting can also be identified. The patient coordinator will track deviations in timeframes or missing data – and when the data goes back to the informatics team, they are able to review the anomalies. This real-time monitoring of progress means that issues are dealt with immediately, rather than affecting data quality and compliance when the study finishes.

As the patient gets to the end of the study, the patient coordinator will provide instructions on the return of any equipment and medication destruction, generally ensuring that the logistics behind closing the study are all dealt with efficiently.

A concierge support service informs patients of what they should be doing, reminds them when they need to do it, and assists them along the way.

The coordinator is the patient’s central point of contact to help support them, and ensure the patient-physician relationship is really focusing on the treatment and care, and less on the day-to-day demands of the study.

Ultimately, decentralised clinical trials are about bringing the trial directly to the patient. With white glove services, patients receive all the necessary support, and sponsors reap the benefits of increased patient retention. These are two critical factors in realising the benefits that decentralising clinical trials can bring.

Reference

1. Hybrid/Virtual/Decentralized Clinical Trials Market Outlook, ISR Report, July 2021.