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.

‍

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.”

‍

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.

‍

Medable CEO Michelle Longmire joins Beyond the Molecule Podcast to discuss how the industry can expand clinical trial access to all populations.

‍

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 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.

‍