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Blog posts
You asked, we answered: How long to plan for your first eConsent implementation
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.
Let’s make clinician reported outcomes a universal language
Get the basics on ClinROs, why they are important, the industry governance around them, and how their electronic versions can benefit clinical trials.
Interview: Biomarker/Endpoint guidance and why they advance science
Colin Miller is Co-Founder and CEO at The Bracken Group, a life science consultancy providing high-level expert support in imaging, regulatory, due-diligence, and more. A scientist by education, Colin has written more than 70 peer-reviewed scientific and medical publications, published 3 books, and holds 3 patents.
How to design patient-friendly and inclusive ePRO instruments
This blog explores why patient-centric ePRO instrument design is critical to driving study success, provides tips on how to make instruments more patient-centric, and offers resources for additional ePRO design guidance.
Meet patients where they are with consent information
The cornerstone of access to any clinical research project is the informed consent process–the decision of a participant to join a study based upon full and complete sharing of information about what the study will require, the risks of participation, and the voluntary nature of that participation.
This isn’t simply the participant’s signature on a paper or electronic form. According to governmental organizations like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), that signature is only part of the process. Of perhaps even greater importance is the provision of information to the patient accompanied by a discussion of the study and a chance to have questions answered, so that the decision can truly be considered “informed.”
How to write clear and compelling patient recruitment material to drive enrollment and boost diversity
Clinical trials are essential for the development of new medical treatments and devices. However, enrolling patients in clinical trials is one of the most challenging aspects of conducting these studies. This is especially true when it comes to recruiting a diverse and representative patient population.
Improving diversity in clinical trials: An industry leader talks progress and surprises
We sat down with Rosamund Round, VP, Patient Innovation Center and Decentralized Trials at Parexel, about the challenge of improving diversity in clinical trials and what Parexel is doing to meet it.
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.
Podcast: How do you ensure clinical trial access for all?
Medable CEO Michelle Longmire joins Beyond the Molecule Podcast to discuss how the industry can expand clinical trial access to all populations.
Where does patient recruitment end and patient engagement begin?
It’s widely understood that patient recruitment is one of the most critical and yet most challenging aspects to a successful clinical trial. In fact, many trials fail to reach recruitment goals, with far-ranging implications for investigators, sponsors, study participants, and the population affected by the disease or condition under study.
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.