Optimizing Evidence and Design Using the Patient’s Lens
Uncover how to work with patients to shape everything from protocols to data collection.
Patient perspectives: The balancing act of trial participation
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.
You asked, we answered: Is electronic ICF revision easier than paper?
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?
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.
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.
Use case: Implementing digital solutions to improve oncology trial experience & efficiency
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.
Report: Medable named #1 Leader in DCT for second year by Everest Group
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.
Technology Overload: Addressing Site Challenges of Digital Trials
Katie madden, Digital & Process Optimization at GSK, joins Medable’s Andrew MacKinnon and Annie Hesslewood to discuss the importance of implementing a change management strategy coupled with a unified digital trial platform that streamlines eConsent, eCOA, sensors, and integration workflows into a single end-to-end experience.
Strategies for implementing eConsent across the European regulatory landscape
Camila Matheny, EVP of DCT Offerings at Medable and Caroline Beaufour, PharmD, Ph.D., Innovation Lead, Clinical Development Support at Servier, dive into the intricacies of implementing electronic informed consent (eConsent) in clinical trials within the complex regulatory landscape of European countries.
DCT Digital Week: Creating the Digital Foundation for Scale in Clinical Development
Learn how sponsors and CROs can improve their clinical trial conduct by developing new strategies that create sustainable, repeatable, and effective clinical conduct.
Assessing the financial value of decentralized clinical trials
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
Development of a mobile health app (TOGETHERCare) to reduce cancer care partner burden: Product design study
Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.
How AI and ML can transform clinical trial conduct
There’s little doubt that 2023 will be remembered as the breakout year for generative artificial intelligence (AI) and machine learning (ML) within both tech and pharma. Much like the surge in digital and decentralized trials in 2020, AI and ML have sparked a paradigm shift in what is possible in the development of drugs and treatments.
With the FDA’s recent publications providing a future framework, sponsors and CROs everywhere are researching how best to bolster drug development. With all these advancements happening at an unprecedented pace, we’re providing an overview of the uses of AI and ML in clinical conduct below.
Back to basics: What are wearables and how are they powering diversity and efficiency
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.
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.