Blog posts
Building a “gold standard” clinical trial experience in Japan
When talking to customers conducting their first multi-country trial, we sometimes liken clinical trials to spider webs. Just as a garden spider’s web differs from a black widow’s, clinical trials follow unique patterns in every region. Each country comes with its own set of rules, ethical standards, approval processes, and data privacy laws. Cultural factors also play a crucial role in how patients are recruited and understand Clinical trials, requiring sensitive communication and a deep respect for participants’ needs.
In Japan, these regulatory and cultural intricacies form a complex ‘web,’ with anchor points and structural requirements that, when understood and implemented correctly, create a framework for success. However, conducting Clinical trials in Japan has historically posed challenges for Sponsors and Contract Research Organizations (CROs). When we first entered the region, one Sponsor consistently cited issues with eCOA solutions and site and patient support, not fully adapting to Japan’s unique requirements. This feedback, combined with our own experiences on the ground, revealed a clear need for improvement.
Today, we can proudly say that the solutions we put in place have transformed Japan’s Clinical trial landscape, and what was once a challenge has now become the “gold standard” for supporting Clinical trials in the region.
Using clear language and the latest technology in informed consent forms (ICFs) for clinical trials
Explore ways to improve the consenting communication process using clear language and the latest technology.
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.
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.”
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 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.
Designing patient-friendly 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.
Clinician Reported Outcomes (CROs): A universal approach
Get the basics on ClinROs, why they are important, the industry governance around them, and how their electronic versions can benefit clinical trials.
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.
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.
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.