Patient engagement is critical on several levels. It helps inform updates to trial design and processes, it ensures critical data is collected to determine the safety and efficacy of an investigational product, and it supports patient retention for the duration of the trial. That’s why biopharma sponsors and research sites are leaning into technology to facilitate this engagement. It’s important for physicians and other healthcare professionals to be aware of this technology and how it can impact their work in clinical trials, if relevant, as well as their patients’ participation in clinical trials.
What does strong patient engagement look like in clinical trials? It looks like active participation in the recruitment process, enrollment process, and treatment phase. The recruitment process includes the period when patients are researching trial opportunities and research site locations, and self-identifying as candidates. The enrollment process involves patients staying in communication with the research site team, showing up for scheduled visits, and providing feedback about the process where applicable. Engagement in the treatment phase looks like making it to every visit, discussing health updates, and answering all questions from the research team to ensure source data forms are completed accurately.
Technology can help with every aspect of this patient journey. Let’s dive deeper into ways technology can provide support through every phase of patient engagement.
There is a rise in patient-facing, trial-specific websites that enable patients to have informed discussions with their providers, to self-identify for a trial, and to start the pre-screening process
The average person spends 400 minutes each day online. The internet connects people to professional platforms, to social outlets, and to resources that inform decision-making, from product information to healthcare education. So if a trial candidate is searching for therapeutic options, it’s ideal that they can find and learn about a trial that is specific to their needs. More biopharma sponsors are investing in trial-specific websites that are user-friendly, quickly and equipping visitors with the information they need to take a step forward in the recruitment process. These websites ideally include:
- An overview of risks, benefits, and eligibility criteria, so patients (or their physicians) can determine whether this trial might be a fit for their individual healthcare needs. This also equips patients to have in-depth discussions with their providers about trial options and next steps.
- A site finder, so patients can confirm the most convenient research location for them.
- A digital pre-screening form, so patients can immediately take the next step in participation by submitting their information and verifying initial eligibility.
Physicians interested in referring patients to trials can aggregate links to these websites in their relevant therapeutic area, and get in the practice of sharing them with patients as options to include in their care plan. Not only do these websites empower candidates to be proactive in their healthcare journey, but it facilitate instant engagement – they can immediately start the participation process and establish a connection with the relevant research site team, increasing patient satisfaction and expediting their journey to treatment.
1. Research sites often implement patient texting systems for convenient communication and visit scheduling.
At a time when 90% of adults in the U.S. have a smartphone, texting is one of the quickest and most convenient ways to reach patients with appointment reminders and any scheduling updates. Because patients can confirm appointment times in a few clicks, this method saves them time while limiting disruptions to their work day or personal schedules, building the perception that trial participation doesn’t carry too high of a burden.
Patient texting is an ideal communication method for healthcare professionals working on clinical trials. It presents a simplified way to respond to any follow-up concerns or questions the patients may have. Efficient scheduling and response times via text can keep the patient engaged in the process – not only are they more likely to not miss visits, they are also more likely to stay in communication with a care team that’s easily available at their fingertips.
2. API connections are enabling referral vendors to send patient referrals to research sites while patient interest is at its peak.
When sites process patient referrals from multiple sources and in multiple formats (such as by phone and email), there can be a delay in follow-up with those patients. More sponsors are working with technology vendors to implement an open API to send patient referrals to the relevant site system right from referral vendors.
This streamlined process can transform pre-screening workflows for healthcare professionals working on clinical trials. When the referrals stream straight into the platform where sites manage patient recruitment and enrollment, sites can rapidly follow up as part of their existing pre-screening workflows. Ideally, this integration allows them to reach out to referrals within 48 hours, while trial participation is top of mind for each patient. When patients are able to quickly establish that connection with their site team, they’re more likely to still be eager to participate and to continue moving through pre-screening and screening to determine eligibility.
Exclusion criteria isn’t the only reason patients drop out of the enrollment funnel. More site teams and their sponsors need to work together to implement pre-screening processes that include digitally logging information about why patients choose to drop out of the enrollment funnel. When sites enable sponsor access to these insights through their clinical trial technology platforms, sponsors can see and address patterns in voluntary patient dropout while recruitment is ongoing. Are patients disinterested? Do they perceive the trial to be too burdensome or too risky? These patterns inform next steps. Perhaps there’s an opportunity for clinical trial sponsors to:
- enhance trial-specific educational resources for site and physician use to strengthen patient interest and alleviate concerns about risks.
- proactively alleviate patient burden by budgeting for transportation services for patients; the easier it is to get to a trial site, the easier it is for patients to participate in the trial and stay engaged throughout enrollment and treatment.
Physicians and healthcare professionals can encourage patients to be open about giving feedback during clinical trial participation. This enables stronger data collection and insights to inform better trial design for the future.
4. eSource solutions are equipping sites to more efficiently and accurately collect patient source data, which can improve the patient visit experience.
The use of eSource can support positive one-on-one interactions between a site staff member and a patient. Flipping through paper source documents during a patient visit is cumbersome and distracting, which limits a patient’s ability to feel engaged in the process. They might not feel fully listened to or seen when paperwork is the main focus. At the same time, lengthy visit times can become a source of stress for the patient – they may feel the need to rush through the visit because of work or other plans.
eSource can trim down patient visit times by 50%. With eSource, site staff can scroll through and fill out electronic source templates built per protocol with a few clicks and keystrokes; they can direct more attention to the patient in the room. Digital progress bars can indicate whether documentation for each visit is fully complete, so staff can move swiftly through the forms with minimal double-checking.
Without maximal patient engagement, patients can drop out of trials, adding to recruitment costs and disrupting timelines. Lags in communication – or insufficient communication – can skew trial data and overall results. Negative patient experiences can weaken trust in and desire to participate in clinical trials all around, limiting therapeutic options. Better patient engagement can start with the technology sponsors and sites use to gather actionable insights and enhance workflows, as well as the online connectors to patients and their care options.
About Eben Scanlon
Eben Scanlon is the Chief Customer Officer at OneStudyTeam partnering with sponsors and CROs to optimize patient recruitment outcomes.