Optimizing Evidence and Design Using the Patient’s Lens
Uncover how to work with patients to shape everything from protocols to data collection.
You asked, we answered: How to Create Your own Multimedia Library for Informed Consent
An often quoted analogy for recruitment into clinical trials is that of the ‘leaky pipe’. In this analogy potential participants drop out of the recruitment funnel at every stage in the process from identification, pre-screening, consenting, screening, randomisation and trial completion.
Research in 2020  showed that of 100 participants identified for pre-screening, only 8 will be randomized, and only 7 will complete the trial. Given that a recent review with the Medable Patient Champion Network (PCN) highlighted that the paper consent process was often considered as ‘intimidating’, the fact that up to 80%  of potential participants are lost during the consent process is not surprising. Metrics such as these highlight the importance of being able to provide a potential participant with the details of a clinical trial in a manner that both engages and educates them. This helps ensure that their very first experience with the trial, and at times the research facility, sets the tone for a positive trial experience.
Once enrolled into a clinical trial, the process of educating a participant and ensuring the consent form is understood, has a direct impact on their retention. Research from CISCRP  showed that 35% of participants that dropped out early from a clinical trial found the consent form difficult to understand, compared to only 16% of participants that completed their clinical trial.
Patient perspectives: Oncology preferences from patients and caregivers on trial technology
This summary looks at DCT patient and caregiver preferences regarding eConsent, telehealth, wearables, and other digital technologies in the area of oncology. There are differences noted between age, gender, and specific types of cancers.
During the pandemic, there was a surge in telehealth visits in medical oncology. Some of the telehealth benefits include convenience, the immediacy of results, news processing, family comfort, and privacy during the receipt of bad news. Although patient preference is individual in nature, there are some common themes. Telehealth has also increased access to medical care and clinical trials (Granberg, et al 2021).
A randomized study for patients undergoing radical prostatectomy showed that those who do accept telehealth visits report a positive view of telehealth. Another study shows that 92% of patients who had telehealth visits were satisfied with the visit. A survey reported that 32% of thyroid cancer patients reported video-based healthcare. Another advantage of telehealth noted by patients is the convenience, especially for short visits with a long commute. The COVID-19 pandemic has had a large positive influence on video visits. These studies noted that only included patients who spoke English and accepted video visits (Granberg, et al 2021).
The Definitive Guide to Digital Evidence Generation
According to Grandview Research, the hybrid and decentralized clinical trial (DCT) market will be worth more than 12 billion dollars by 2030. Sparked by the COVID-19 pandemic of 2020, the rapid ascent of patient-centered technology and the digital and decentralized trials they’ve spawned has forever changed the landscape of clinical conduct. Sponsors are increasingly turning to DCT platforms in alignment with the rise of Life Science and Software-as-a-Service (SaaS) solutions. For those who haven't made the jump yet, there are many questions, including "What is a decentralized clinical trial?" Find out with this in-depth guide to decentralized clinical trials. Uncover how they work, their benefits, and how they transform clinical development.
Patient perspectives: Nine updated technology tips for deploying eConsent from Medable’s PCN
Since 2018, Medable has grown a network of patients, caregivers, and care partners whose job is to help improve the clinical trial experience for participants.
Known as the Patient Caregiver Network (PCN), they regularly update their best practices, including recently refreshing their technological best practices around deploying eConsent.
We’re sharing them below to help continually promote the participant's voice and to help foster more equitable, inclusive, and diverse clinical trials
Back to Basics: What is clinical trial recruitment?
Patient recruitment is one of the most critical elements of a clinical trial. Without sufficient participation, studies will lack the power to demonstrate the statistical significance and efficacy of new treatments. Ultimately, poor patient enrollment will delay or prevent new therapies from reaching the market. Not only do such delays cost millions of dollars, but they also deprive patients of effective, potentially life-changing treatments.
Back to basics: What is patient screening?
Patient screening, a vital step in the clinical trial recruitment process, is when interested participants are assessed for their eligibility for a given trial using select inclusion/exclusion criteria. These criteria help characterize the target patient profile to ensure patient safety, better efficacy, and optimized signal detection.
Traditionally, patient screening was done in person at a clinical trial site. Due to the current digital revolution in healthcare, which has recently accelerated in response to global health events, the ability to use cloud-based software and digital qualification steps to optimize patient screening and enrollment brings innovation, convenience, and sophistication to this process.
Back to basics: What is electronic informed consent (eConsent)
While informed consent form (ICF) signatures traditionally have been collected on paper at a physical site, today’s digital approach — electronic consent (eConsent) — offers more than high-tech signature collection. It provides an upgrade to patient education and communication as well, empowering participants in new ways. Moreover, eConsent can democratize clinical trial access, allowing researchers to recruit broader and more diverse participant groups through entirely remote consenting processes. This broader and less burdensome access also can increase the speed of recruitment and reduce drop-out rates.
Back to basics: What are electronic clinical outcome assessments (COAs/eCOAs)?
COAs (called eCOAs when captured electronically) are essential to understanding whether a drug is reducing symptoms, improving patients’ quality of life, and improving patients’ ability to perform activities they care about. COAs enable a well-rounded understanding of how a drug is working, its side effects, its impact on patients’ lives, and more. Perhaps most notably, PROs/ePROs allow for the patient’s voice to be heard. Capturing the patient’s voice is particularly important because the clinician may not always see or express the patient’s experience in the same way.
Quality by design: How eCOA improves oversight and participant data quality
eCOA has the power to ease clinical research for all stakeholders. When developing and refining our eCOA offering, we consulted with our own Participant & Caregiver Network (PCN) to provide feedback on design. This allowed us to build our eCOA and the wider platform it fits within in a way that fosters better oversight, and better clinical trial data.
Why the future looks bright for eCOA in clinical trials
See why the electronic clinical outcome (eCOA) market is poised to continue its rapid growth and why Medable customers have chosen eCOA as a future foundation for their next era of clinical conduct.
What does the new European Medicine Regulatory Network recommendation paper on decentralized elements in clinical trials tell us?
Learn what impacts the new European Medicine Regulatory Network recommendations paper means to your clinical trial operations.
New EU Regulatory Recommendations for Decentralized Trials Keep Focus on Patients and Sites
As clinical trials rapidly modernize, government regulators work to evolve even as the same core principles apply. Still, decentralized clinical trials are – simply – clinical trials, as all research today is decentralized in some way, yet we lack global harmonization of regulations.