How well do clinical trial participants understand informed consent?

Lisa Moss Calderwood, MA

Senior Medical Writer

Artcraft Health Clinical Trials

The Nuremberg Code was one of the first formal decrees for the use of informed consent for participants in clinical research. Emerging in 1947 as a form of protection for human subjects in research, the establishment of informed consent was an internationally shared ethical response to the inhumane “research” conducted by Nazi scientists. Since then, informed consent ensures that participants in clinical trials are ethically treated and informed of any risks or benefits prior to joining a research study. Volunteering is a key tenet of informed consent, as are the concepts of disclosure, understanding, competence, and consent. 

Given its historically important relevance, and that there are over 160,000 active clinical trials worldwide, it’s important to ask how well do patients really understand informed consent? For that matter, how well do they understand potential risk or the difference between research and therapeutic treatment (all of which should be explained during informed consent)?

CenterWatch, which maintains a database of global research studies, published a brochure for potential clinical trial volunteers that explains the informed consent process. It includes results of a 2009 CenterWatch survey in which 672 volunteers were asked how well they understood the possible risks before and during the trial. The responses from 28% of the volunteers indicated that they did not understand that they could encounter additional risks or discomfort during the trial. That lack of understanding can lead to anxiety, distrust of clinical research, or early withdrawal by participants from studies. 

What’s missing here? Education. At Artcraft Health Clinical Trials (AHCT), we understand informed consent is ideally an ongoing, dynamic process during a clinical trial. It doesn’t end when a patient signs a form before joining a research study, although making certain a prospective volunteer clearly understands what to expect before enrolling is paramount. 

Crafting clear, actionable, relevant, and engaging educational solutions that promote active awareness of study goals can go a long way in helping study participants understand what to expect before and during a trial. In other words, education should be a part of every clinical trial’s recruitment and retention plan. AHCT works closely with an array of clinical trial sponsors to provide learning strategies that support patient-directed adherence and knowledge. Our goal is to help site staff continually engage with the patients they enroll. That way, study teams can be confident that their patients fully understand informed consent and all the relevant aspects of their role in the research process. And that can make all the difference in the trial’s successful outcome.  

Learn more:

·         CenterWatch. Understanding the informed consent process. http://www.centerwatch.com/pdfs/informed-consent-brochure.pdf. Accessed March 31, 2014.

·         Knifed E, Lipsman N, Mason W, Bernstein . Patients’ perception of the informed consent process for neurooncology clinical trials. Neuro Oncol. 2008;10(3):348-354. http://neuro-oncology.oxfordjournals.org/content/10/3/348.full. Accessed March 27, 2014.

Artcraft Health Clinical Trials has expertise in creating patient recruitment campaigns, as well as retention and patient education strategies. Contact Brian Schaechter, Director, Business Development, Clinical Trial Markets.

Phone: 908-483-4241       e-mail: bschaechter@artcrafthealthCT.com

Outsourced Clinical Development

Tom Savonick

Since its beginning in the 1970s, outsourced clinical development has moved from one-stop shopping to an approach offering a greater range of options.

The industry began with the contract research organization (CRO). By the 1990s, full-service CROs provided sponsors with all services and expertise needed to move a new drug or device from conception to marketing approval, without the sponsor having to maintain a staff for those services. One shortcoming of a CRO is that it may not provide a consistent level of service across every function that it performs. 

Another model of outsourced clinical development, the functional service provider (FSP) model, addresses that shortcoming. The FSP model supports selection of individual services rather than the “one-stop shopping” provided by a CRO. This enables sponsors to select the a service provider from each discipline rather than focusing on one provider to perform all services. 

The latest trend in outsourced clinical development is the niche service provider, which provides a high level of expertise for a specialized service. Artcraft Health Clinical Trials (AHCT) provides sponsors with an array of high-expertise services in 7 key areas:

•    Recruitment

•    Eligibility

•     Retention

•     Consent

•     Compliance

•      Education

•     Communication

AHCT’s customized services provide clinical trial sites with tools and solutions to help them meet recruitment timelines, enroll qualified participants, educate them about the study and the importance of compliance to protocol, and retain them throughout the study duration.

Low compliance and high dropout rates are 2 of the most daunting challenges facing sponsors. Recent studies have shown that participants’ compliance and retention are strongly affected by how well they understood the study when they opted to enroll. A poor understanding of the study can lead to poor compliance and even dropout. AHCT ensures that participants thoroughly understand their role in the study through customized informed consent documents and study guides that lower the literacy level by:

•         Replacing legal and medical jargon

•         Using plain language

•         Including phonetic pronunciation guides

•         Adding pictures, icons, and other visual elements

•         Using plenty of white space

•         Providing participants with clear, ease-to-follow schedules and calendars

These steps ensure that participants thoroughly understand the study and what is expected of them. By eliminating the surprises faced by participants, sponsors can ensure maximal compliance and minimal dropout rates. Like all niche service providers, AHCT can employ its services regardless of how you choose to source your study.