Trends, insights, and news from SCOPE 2024
With over 3,300 attendees across 850 companies, the 16th annual Summit for Clinical Operations Executives (SCOPE) was a huge success. As previous years have shown, what’s big at SCOPE tends to be big for our industry. Thus, we’re summarizing some key takeaways from this year’s conference to understand where the industry may be headed next.
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.
ePROs: Transforming oncology trial research
Over the last decade the number of oncology trials has skyrocketed, almost doubling the number of all other therapeutic areas combined, according to the WIRB-Copernicus Group¹. Known for their complex design, oncology trials often present various participant, site, and sponsor hurdles.
Sponsors and CROs looking to tackle these challenges andreduce the burden on participants and sites should explore the potential of digital solutions, particularly electronic informed consent (eConsent) and electronic patient reported outcomes (ePRO). Both tools offer expanded views of the participant journey while offering feedback that enables sponsors and CROs to enhance and refine their trials for all stakeholders.
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.
Back to Basics: What is a decentralized clinical trial?
In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary.
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.
What it really takes to adopt eConsent across large pharma
Learn about the benefits of adopting consent management technology and best practices around developing change management and training programs to help sponsors, CROs and sites get the most out of eConsent.
Digital vs digitized: Common myths about eConsent for clinical trials
Alex Burrington, CTI Principal of Vertex, and Andrew Mckinnon, VP, GM of eConsent discuss common myths around eConsent, how to improve comprehension with patient-centric consent, and how to use a digital consent management tool to improve trial compliance, quality, and oversight.
White paper: Why eConsent primes patients and studies for success
Read this white paper to learn how eConsent's flexibility helps you educate and retain patients worldwide, regardless of signature requirements, and how to implement it across your organization.
Using clear language and the latest technology in informed consent forms (ICFs) for clinical trials
Explore ways to improve the consenting communication process using clear language and the latest technology.
White paper: The foundations of decentralized clinical trials
Understand the benefits of web-enabled research tools and how they work.
Improve trial enrollment using patient perspectives and technology
In this webinar, Nisha Trivedi, Patient Advocate, and Jena Daniels, VP of Patient Success showcase how adding technology in clinical trials enables greater diversity and an increase in study enrollment upfront and maintains patient engagement over the course of the study.
- Establishing internal relationships with end-users (patients, caregivers, and sites) will increase technology adoption
- Using technology to increase participant access, engagement, retention, and education
- Navigating uncertainties in technology and approach while balancing the needs of participants providing them with a positive and differentiated experience
- Ensuring patients, caregivers, and sites are engaged in the study design and implementation process