From eClinical data collection to telehealth to wearables and beyond, the clinical trials industry has seen a mass of technological advances over the past decade. Informed consent is critical to every clinical trial, but often a daunting process from the patient perspective.
The Benefits to Patients
In a paper-based consenting process, many forms are 15 to 20 pages long. That’s a lot of content to consume in a short period of time. Twenty pages could take close to an hour to process, and if you factor in patient questions and concerns you could easily be looking at a multi-hour process. Studies have found that patients prefer simpler and easier to read Informed Consent Forms that can provide them the necessary information to make a decision regarding participation in the trial.1
While required by regulators, the purpose of informed consent is so that patients are aware of the benefits and possible risks associated with treatment. Consent requires patient understanding, which can be improved by using electronic tools that enable rich media content, including videos. Comprehension requires that the patient be able to understand the information presented and have the time and opportunity to read, evaluate and consider the information presented.2
Researchers have studied the merits of an electronic informed consent process and found that patients prefer this method over paper for a number of reasons. Patients felt the electronic process was less stressful because it gives them a greater sense of control and allows them to proceed at their own pace. They liked the hierarchic and modular approach to providing information and felt that the use of video made information more understandable.3
Reducing patient burden has proven to increase retention by 70%. When many studies are failing to meet their recruitment goals, retention is critical. eConsent puts the patient in control of their consenting process. Empowering patients to make informed decisions increase patient motivation to remain in the study. In addition to patient empowerment, eConsent also allows for rich multi-media, proven to increase patient comprehension. 3
Regulatory Compliance
At Medrio, we offer flexible configuration making the switch from paper to eConsent easy to manage on the backend, while offering benefits to patients on the front end. Our solution enables you to instantly propagate the latest version of compliance documents across all sites. In addition to videos and graphics, Medrio eConsent gives you the option of using FAQ documentation and quizzes to ensure patient understanding. Our eConsent solution is safe and secure and meets or exceeds IRB guidelines for the consent process.
From ICH/GCP and 21 CFR to GDPR and HIPAA, we give you the tools to focus on the trial and the peace of mind that your data is compliant.
With decentralized clinical trials on the rise, now is the time to re-evaluate your consenting process.
References:
1. Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Dresden GM, Levitt MA Acad Emerg Med. 2001 Mar; 8(3):246-52.
2. Readability and Comprehensibility of Informed Consent Forms for Clinical Trials Dr Anvita Pandiya Perspect Clin Res. 2010 Jul-Sep; 1(3): 98–100.
3. The Use of Multimedia in the Informed Consent Process Holly B. Jimison, PhD, Paul P. Sher, MD, Yvonne LeVernois, RN, MS, MPA J Am Med Inform Assoc. 1998 May-Jun; 5(3): 245–256.
