Blog posts

When we think about clinical trials, our minds often gravitate toward the scientific intricacies of these studies - the testing of new treatments, data analysis, and the quest for medical breakthroughs. However, it's essential to remember that behind every clinical trial, there's a patient, and often a caregiver, whose life is deeply impacted by this journey. 

So, let’s consider this: the concept of "Participation-Life Balance" and how technology can enhance the design and workflow of clinical trials while acknowledging the holistic needs of patients and caregivers to work towards achieving this. 

‍

One of the most common questions we’re asked about digital informed consent/eConsent is: What does the ICF amendment or revision process look like within a digital platform and is this harder or easier than traditional paper based approaches?

‍

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 ^[1]  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% [2] 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 [3] 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.

‍

When technology enters a regulated environment, early adopters often cite regulatory uncertainty as a hurdle. In fact, a 2021 Clinical Trials Transformation Initiative (CTTI) survey showed that regulatory uncertainty and lack of harmonization were the top reasons that hindered adoption of elements of decentralized clinical trials (DCTs). 

During the COVID-19 pandemic, the increased adoption of decentralized methodologies was guided by temporary guidances put out by many regulators such as FDA’s March 2020 “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency” and the corresponding EMA guidance, which explicitly mentioned it would expire at the end of the designated Public Health Emergency. 

‍

Since 2018, Medable has employed a network of patients and caregivers whose job is to help improve the clinical trial experience for participants, sites, and coordinators. Their work is designed to help facilitate equitable, inclusive, and diverse clinical trials. They are called the Patient Caregiver Network (PCN).

Medable’s PCN is comprised of over 80+ members representing various indications who have each participated in, or assisted with clinical conduct. 

With the landscape of pharma shifting, Medable recently surveyed its network to identify what’s working, and what isn’t, in the world of digital evidence generation. We’ve collected their responses and are summarizing their sentiments below in order to help further clinical research and to help bring effective therapies to patients faster.

‍

‍

Implementing digital  informed consent (or eConsent) in clinical trials can be challenging and complex, but it doesn’t have to be!  One of the main reasons for this difficulty is the traditional mindset and habits of conducting clinical trials. Clinical trials have long relied on paper-based informed consent process, and making the switch to a digital solution requires a significant shift in mindset and approach. Additionally, different stakeholders, such as study sponsors, ethics committees, regulators, sites and patients, may have different expectations, perceptions and requirements for eConsent implementation, adding to the complexity of the process. Therefore, careful planning, communication, and a thoughtful execution are essential for the success of an eConsent implementation and adoption in studies.

‍

Over the last four days, the DIA 2023 conference has Illuminated downtown Boston as thousands of “industry, regulatory, government, academics, and patients” come together to  “problem-solve, and discuss global and local challenges facing the life sciences community.”

Much like JP Morgan week and SCOPE before it, what happens at DIA often makes waves across our industry, helping set the tone for our future.

Thus, we’re providing some of the biggest and brightest takeaways from this week’s conference below. 

‍

Obtaining approval of an electronic informed consent doesn’t have to be a complex and time-consuming process. While the review process involves multiple stakeholders,  including sites, sponsors, Ethics Committees (ECs), Institutional Review Boards (IRBs), and Health Authorities (HAs).  Researchers and study teams are constantly looking for ways to streamline their processes and improve efficiency. 

While the paper consent review process has remained the same, we have seenmany layers of improvements and efficiencies around electronic informed consent forms (eICFs). eICFs have emerged as a solution to help participant understanding and engagement, trials accessibility, and improve data quality. 

However many researchers still are hesitant to adopt due to concerns about the submission process, timelines, and regulatory compliance. In this blog, we will discuss how to overcome these obstacles and streamline the ethics review process by adopting eICFs.

‍

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).

‍

‍

Along with some of the best companies in the world, Medable is proud to join CancerX as a founding member. This alliance is co-hosted by the Moffitt Cancer Center and the Digital Medicine Society (DiMe), alongside the Office for the National Coordinator for Health Information Technology (ONC) and Office of the Assistant Secretary for Health (OASH). 

At the beginning of April 2023, the FDA published a draft of the fourth in a series of Guidance Documents entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints For Regulatory Decision-Making”.  Once finalized these four documents will be combined and will replace the 2009 Guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”.  Part 3, which was released in draft in June 2022, provides advice around the development and validation of new COA (including the modification of existing COA).

‍