Medable perspective: Three points on FDA eCOA guidance
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).
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
Podcast: Michelle Longmire and David Fajgenbaum of EveryCure join the PharmaExec podcast
Medable CEO Michelle Longmire and Dr. David Fajgenbaum, co-founder of EveryCure, join Pharmaceutical Executive podcast to talk about their partnership adn navigating the regulatory landscape.
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.
Case study: Optimizing choice, flexibility and outcomes with Patient-First Data Collection for Oncology
Medable worked with a top 5 pharma company to increase the safety of patients as anti-cancer treatments may cause pulmonary toxicity, ranging from asymptomatic radiological changes to respiratory failure, and is considered a common side effect.
eCOA Digital Week: An honest assessment of eCOAs from a site perspective
Joe Dustin, VP/GM of eCOA and Annie Hesslewood, Site & Patient adoption lead at Medable host an open discussion with a panel of sites and CRAs to provide a candid assessment of how upcoming changes in the eCOA landscape can reduce burden on participants and sites to maximize the chance of success in clinical trials.
Leverage novel options in oncology clinical trial design to reduce burden for patients and sites
Flo Mowlem, Senior Director, eCOA Science & Solutions shares insights on how electronic solutions, with a focus on patient-reported outcome (ePROs) can reduce burden on participants and sites to maximize the chance of success in oncology clinical trials.
How to supercharge real world evidence generation in Phase IV trials
Experts from Medable, Syneos, and Pluto Health discuss how they have partnered to deploy patient-first digital trial solutions that leverage RWD, transforming it into actionable RWE insights for a sponsor client.
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.
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 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.