As the pharma world embraces digitisation with electronic consent (eConsent) forms, wearable devices, and artificial intelligence enhancing the accuracy of data collection, patient engagement and retention remain key challenges for clinical trials.
Recurring issues in the recruitment and retention of patients are some of the most common reasons behind a trial failing. According to GlobalData, of the nearly 14,000 clinical trials suspended, terminated, or withdrawn between 2011 and 2021, the largest proportion (28%) did so due to low accrual rates.
Patients leaving can seriously derail a trial’s progress, causing inefficiencies and costly delays as replacements are sought, but may not even be found. Additionally, the trend towards precision medicine and the treatment of rare diseases means that some clinical trials have a very small patient pool to draw upon. More must be done to support patients and improve historically poor retention rates for studies to proceed as planned.
One major contributing factor to low patient retention and accrual is informed consent forms (ICFs). These complex, time-consuming documents employ technical and legal jargon, which can either put participants off in the early stages or cause them to withdraw later in the timeline because they have misunderstood potential side effects, study requirements, or how their data will be used.
New digital features such as eConsent are improving participants’ understanding and help ensure they are fully aware of a trial’s requirements from day one. Beyond improving ICFs, establishing a dedicated study coordinator can do much to make connections with patients and help them feel included. By simplifying paperwork and adopting a patient-centric approach, trials can boost retention and recruitment for a more cost-effective and efficient clinical study.
Embracing trial digitisation and building understanding with eConsent
A relatively recent development has been the pharma industry truly embracing digitisation, driven initially out of necessity amid the Covid-19 pandemic. However, there remains untapped potential in the integration of digital solutions for enhanced patient recruitment. Leveraging technology and data – such as electronic health records and patient databases – can help identify eligible patients much more efficiently.
However, strategies for retaining these patients must begin during the first steps of the onboarding process. To avoid confusion and potential dropouts, participants need to be fully informed of the procedures, risks, and requirements that the trial will involve.
eConsent is an essential component of modern clinical trial software, allowing patients to read and sign informed consent documents online. Not only does this reduce paperwork and admin for the trial site, improving efficiency, but eConsent also simplifies the consent process to improve patient engagement. Ensuring patients are fully aware of the risks and requirements of the trial through eConsent reduces misunderstandings and confusion later in the trial timeline.
Enabling the adoption of eConsent in clinical trials
Despite the many benefits of eConsent, there remain obstacles to the wider adoption of this transformative digital solution. A poll conducted by Viedoc in February 2024 found that regulatory requirements were the biggest anticipated barrier to eConsent, cited by 69% of respondents, followed by issues with technology (15%), and site resistance (15%).
For digital integration to be successful, sponsors and CROs must partner with expert tech providers whose software is not only reliable and easy to use, but also meets regulatory requirements. eConsent facilitates the conducting of remote trials, enabling patients who might previously have been unable to participate due to distance from the trial site or other factors such as mobility issues and the demands of their jobs.
However, if the software is not intuitive, this can cause further frustration among participants, especially if the consent process is undertaken remotely. Patients need tech that supports them, as well as the means for effective communication with the trial site should any issues arise.
Solutions such as Viedoc’s Connect feature provide a fully integrated telemedicine solution for eConsent. Secure video calls facilitate the eConsent process, run pre-screening and recruitment activities, and conduct follow-up meetings when on-site visits are not possible.
These interactive meetings can boost patient confidence going into the trial to maximise participant retention rates. Alongside this, supporting software such as Viedoc Me helps patients submit electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA) through simple, intuitive software. Together, these features ensure that patients remain engaged and informed throughout the trial process, minimising dropouts and delays.
Adopting a patient-centric approach to improve retention rates
Alongside investing in the right tech, sites can also improve patient retention by establishing a dedicated study coordinator responsible for patient management. A study coordinator can serve as a dedicated point of contact for patients, providing a friendly face to address any concerns. Coordinators can also send reminders and messages to participants so that appointments and data input aren’t neglected.
Small gestures that can help reduce the trial burden on participants include offering travel reimbursement and meal vouchers for any journeys to the site. For patients being monitored remotely, it is essential that the sites establish a regular catch-up time so that participants can raise any concerns and feel that they are being looked after during the trial process.
Technological tools that work together – such as the components of the Viedoc eClinical suite – can make engagement with participants easier, supporting retention for the complete duration of a clinical trial and beyond.
To learn more about how Viedoc’s software can help manage your clinical trial needs, click the link below.
