Quality by Design: Better data using participant insights
Quality is not an afterthought within clinical trials. Instead, it is a required and integral part of the entire process beginning at the start of protocol design. While clinical trials will always encounter challenges in driving quality experiences and data, there exists one approach that’s backed by regulatory agencies and proven to lead to better outcomes.
This is a “quality by design” strategy that’s informed and driven by all stakeholders, including those most affected by your trial’s protocols - your participants, and sites.
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.
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: Surveys reveal what works best for patients
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.
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
Patient perspectives: A year of pharma webinars showcase what’s working and what needs work
Learn what industry topics, trends, and focuses are being well received by patients and caregivers with this blog.
How to bring patients into the product journey
Technology today has given patients unparalleled access to information and influence over their health care. As a result, many clinical trial sponsors now recognize the importance of taking a “patient centric” approach to clinical trials. That means designing a treatment, clinical trial, or other health solution centered around the patient, and includes getting feedback from patients, caregivers, families, and advocacy groups every step of the way.
In other words, it means treating patients as informed stakeholders whose participation is key to a successful trial and product following marketing authorization. Engaging patients and truly bringing them into the product journey has the power to transform the future of research and medicine. Read on to understand what patients expect from clinical trials today, and how to engage them throughout the product journey.
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
Informed Consent Forms (ICFs) for Clinical Trials: Write with plain language please
Informed consent is a critical element of any clinical trial, as it starts the process that leads to a patient's participation in a trial. An informed consent form (ICF) is written by sponsors and delivered to patients to provide them with all the information they need about the study to make an informed decision around their participation. Traditionally done with paper-and-pen, an effective ICF is clear, concise, and straightforward, while covering all of the required elements defined by regulatory bodies, such as Good Clinical Practice (GCP) as defined in ICH E6(R2). Unfortunately, many ICFs are not well-written, use overly scientific language, and are overly complex, which can confuse and potentially alienate a potential participant. This blog examines ways to improve this important communication process using clear language and the latest technology.