Knowledge Center

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.

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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. 

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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.

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A top 10 pharmaceutical company looked to Medable to streamline participant burden and enhance site and team experience in oncology trials, while establishing a scalable template for future trials in oncology and other areas.

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For the second consecutive year, Medable has been named Leader decentralized clinical trial products per the Everest Group’s PEAK Matrix^® assessment, which evaluates DCT products from 24 companies based on vision, capability and market impact.

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Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted

Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.

Mobile health technology, like medical-grade wearabledevices, can transform patient monitoring by enabling the collection of newtypes of data and better accuracy of patient responses. This tech can increaseaccessibility of trials for patients and even increase diversity and reducepatient burden by removing geographical and travel barriers.

As a result of these myriad benefits, we’ve seen theincreasing inclusion and acceptance of wearable devices throughout clinicaltrials. Here, we’ll dive into the specifics of these helpful tools and theirimpact on the future of medicine.

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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. 

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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.

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