Transformation of Clinical Trials Through Digitization—Are We Yet Thinking About the Site?

In my previous blog, I reflected on the importance of considering the patient (becoming more patient-centric) as we increasingly adopt a digital-first approach to running clinical trials. The other essential contributors to the success of clinical trials are the clinical sites, as they are often the end user of the ever-increasing number of digital solutions that are dramatically altering how sites conduct trials.

Challenges sites face while running clinical trials

The ability to recruit patients for clinical trials has long been on the critical path to trial success with, CROs and specialized recruitment companies investing significant efforts to avoid delays due to slow enrolment and achieve the required patient numbers. These issues become more prominent in rare disease trials. Sites with sufficient patients often face heavy competition from larger sites pulling in patients from a distance who do not want to return for follow-up visits. Thus, retention becomes an issue.

Finding potential patients only to see them not contribute to a trial is perhaps even more painful than not finding them. 2021 DT Consulting, an Indegene company, research shows only 7% of the initially identified participants complete a trial . Therefore, to succeed, sites need to be able to recruit but also retain patients.

So how can digitization support sites transform the way they operate and address these issues without providing onerous new challenges?

Next-generation recruitment approaches

While looking at factors that can help drive the success of sites, it is important to be aware that, for smaller sites, their relationship with sponsors gives them access to new approaches. So, while they can dramatically transform the way sites operate, there are more complex questions on how they get access to these new approaches. For now, we focus on the approaches available and how they can drive sites to be successful, but we will, in a future blog, return to the broader question of independent adoption by sites.

Traditional approaches to recruitment meant outreach through phone/text/email mixed with radio/TV-based advertising. We are increasingly seeing the adoption of complex multichannel approaches to drive recruitment into next-generation trials. Patient communities and networks of healthcare professionals (HCP) both provide the possibility to engage with patients and build awareness of participation in research. The patient communities provide patients with much-needed resources to help them understand and manage their conditions while also providing opportunities to talk with other patients on issues of concern. These forums can then link patients with information about clinical studies and introduce them to the recruiting sites. Although built out of a technology platform, this technology has a lower impact on the sites as it drives patients to the study rather than requiring outreach. The more sophisticated communities could even start to generate their own valuable data—for example, by asking patients to use medical-grade wearable devices, providing them with an additional marker for screening, as well as providing valuable data back to the patient.

Similarly, we can notify HCPs who are part of a network about studies and, in turn, bring them to their patients’ attention. The patient–HCP relationship is generally very strong, and patients may proactively volunteer for studies recommended by their physicians.

We can supplement these methods of driving inbound interest with social media outreach in local languages . The initial screening of patients through whichever route they come in from can then be conducted by compliant web tools on sophisticated websites. Importantly though, these new approaches do not simply revolve around technology—human interactions remain equally important to patients and therefore, organizations are creating new “human” roles like the use of trained nurse concierges. They can conduct secondary screening of potential study participants via web-based approaches ensuring that participants are smoothly enrolled and get adequate support as a trial progresses.

In addition to creating greater patient awareness of trials, we can build more complex recruitment approaches leveraging the ever-increasing volumes of data available in structured and unstructured databases. We can interrogate EMR databases with advanced statistical techniques, including Natural Language Processing and Artificial Intelligence. For example, searching for appropriate ICD-10 codes in a physician’s notes and identifying appropriate patients and/or HCPs, who can then be targeted using click-through advertising that leads to web tools or directly into a centralized nurse screening process. It is, of course, essential to protect the identity of patients while exchanging data or aggregating into a centralized data environment to reap the benefits of AI/ML engines , but if done correctly, the benefits can be significant. In a recent study, Indegene identified more than 2000 patients via a live EMR integration while ensuring that patients’ personal identifiable information (PII) was anonymized before analytics kicked in.

Similar interrogation of EMR data can help sites understand potential patient groups within their networks and match them to rightly fitting research trials. We can find other sources of potential patients in claims and lab data. More recently, we have seen major pharmacies exploring the potential of the data they hold for patient identification. In addition, these pharmacies own high-street locations that potentially allow them to become involved in the trial process and supplement the main sites with hyper-localized site facilities for less complex patient visits.

Next-generation retention approaches

Once a patient has been identified and onboarded as a trial participant, making their journey as smooth as possible and retaining those patients for the duration of the trial is key to the success of the trial and the success of the site. The COVID pandemic saw telemedicine used in day-to-day healthcare as an essential tool to ensure continuity of care. Sites are increasingly using similar video solutions such as televisits for remote monitoring. While critical and/or complex parts of the schedule may require visits to physical sites, where logistics allow, sites can perform some of the ongoing activity remotely, using televisits. Sites can make this hybrid participant journey easier by utilizing other technology. For example, they can use apps that provide a clear schedule of activity (with reminders) and support with logistics such as getting a patient a taxi to the site when required and shipping medication directly to the patient. In addition to using televisits for simpler assessments, sites can replace more complex assessments with a visit to a local pharmacy (as mentioned above) or a nurse visiting a patient’s home. Technology can provide a platform to support the logistics and ensure that the protocol is adhered to. Again, we cannot consider technology a panacea in isolation from strong and timely human support. For example, televisits are only an improvement on a site visit if they are easy to join and the quality of the call is high. So, we require a human support wrap for those patients to whom this is all new, for example, someone who can walk a patient through how to use the hardware and, if required, provision a broadband connection.

These approaches, if applied correctly, can all make incremental improvements to the patient experience and increase the chance of them contributing to the life of the trial.

Next-generation sites and their role in a successful clinical trial

It would seem that a site that adopts new approaches to recruitment becomes a happier site. Recent research by DT Consulting surveyed more than 300 trial sites to identify what factors were linked to a perception by the sites that pharma companies were meeting their expectations—that is, what makes a site happier. Revealingly sites that adopted digital recruitment and retention tools were happier, and those using their own websites were less happy. It clearly suggests that what is a fairly recent acceleration in the use of digital approaches built on RWD to identify and recruit patients has landed well with the sites.

Although a fully decentralized trial would move all activity away from a physical site, the reality is that most trials will not be fully decentralized. Instead, as appropriate to the protocol, certain elements will be carried out remotely (a hybrid approach). This increased flexibility benefits both patients and sites by reducing the travel and time burden on patients providing access to a larger (and more diverse) patient population.

The next-generation site can be part of an expedited recruitment process. It can attract patients by leveraging internal and external patient/HCP networks. It can also use its EMR assets by moving them through a website that can both screen and provide a platform for nurses to support patient enrolment. Once on the study, a concierge service can ensure the patient knows what they need to do, when, and where. Support them with logistics, such as reaching the primary site, and provide alternatives so they can remain closer to home with access to local subsites or receive visits from trained clinical staff at home. A site that has embedded these new approaches in its operations can truly differentiate.

Although the broad themes above (recruitment and retention) clearly drive the overall success of a trial, they are also key to how a site, successfully or not, contributes to a study. Drawing on a wide range of approaches to help the sites with recruitment and then retention allows the sites to focus on delivering the highest quality of clinical input. However, the exciting array of tech-driven solutions outlined above is only of use to the sites when they complement these with excellent proactive training and ongoing support through simple but comprehensive online content, and a 24x7 multilingual helpdesk.