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JR: What are some of the problems with current methods of patient consent for clinical trials?
FA: Before they can participate in a clinical trial, patients must read and sign a lengthy paper document that contains need-to-know information about the trial. The document includes how the drug or device works, potential risks and details about how many times they’ll have to visit the doctor. This paper-based process is susceptible to clerical errors, such as signing the wrong form or writing the wrong date. Such errors are among the leading causes of FDA findings, and can lead to financial repercussions.
Less obvious, but equally challenging, is patient confusion about some of the information presented to them. For example, the medical terms and procedures are sometimes hard to understand when written. This can lead to the patient forming partial misunderstanding and assumptions which can weaken the line of communication between patients and site staff and damage a patient’s trust in the clinical trial process.
Electronic informed consent (eIC) can eliminate typical clerical errors and introduce operational efficiencies. When properly designed, eIC can improve patient comprehension and potentially decrease protocol violations as a result of patient misunderstanding of trial detail, that can result when patients do not fully understand the details of the trial.
JR: What are some of the benefits of improving the consenting process?
FA: By mitigating clerical errors, a sponsor can minimise delays due to clinical trial inefficiency.
Enhanced patient consenting can also support higher patient retention because when patients are empowered with information they fully comprehend, they are more likely to ask their doctors relevant questions at the time of consent, instead of entering a trial blindly and opting out before completion. At ICON, we call this truly informed consent.
JR: ICON recently launched Firecrest eConsent. Can you tell us more about this solution?
FA: Firecrest eConsent is a component of ICON's new Informatics Hub, which that was designed to enhance patient engagement during drug and medical device development and is based on research data and findings. Improving the informed consent process is a critical component of improving overall engagement.
Firecrest eConsent simplifies the patient consent process and provides increased transparency to study staff. It uses visually compelling multimedia to thoroughly explain the trial. The content is developed using evidence-based research that ICON is currently sponsoring at Carnegie Mellon University. The platform works on several types of devices, from US signature pads to smartphones. It automatically populates the date, prevents investigators from saving forms without signatures and contains a unique mechanism to validate signatures. These features make the administration of patient enrolment easier for investigators and reduce the risk of protocol violations and importantly better comprehension instils trust in the patient.
JR: How does Firecrest eConsent address FDA recommendations and improve the consenting process?
FA: In its recent draft guidance on electronic informed consent, the FDA clarified existing policy in order to help sponsors improve the informed consent process.
One key takeaway was that the FDA allows electronic signatures, provided the sponsor can validate that they are written by the patient. Firecrest eConsent uses a new proprietary method to capture, confirm, encrypt and store biometrics for each patient's signature. Electronic signatures simplify the process, cut down on paper and minimise the chance of error.
As part of that same draft guidance, the FDA recommended a more patient-centric approach to the presentation of clinical trial information. This can be achieved in many ways, for example, by tailoring the educational portion of the consenting process to the intended patient audience in order to increase comprehension and retention.
Firecrest eConsent employs videos and visual aids to assist in the explanation of complex scientific concepts and medical terms found in trial protocols. Patients can access these materials via portals or through other online channels provided by the sponsor, giving them more time to independently review and prepare questions for the physician before consenting to participate in the trial. While this notion of “ample time” was not explicitly addressed in the most recent draft guidance, it is required in the ICH GCP guidelines and should thus be a major focus of any electronic consent platform.
JR: ICON worked with Carnegie Mellon University in the development of its eConsent platform. Can you tell us more about this?
FA: The educational techniques used in Firecrest eConsent were developed based on ICON-sponsored research by Carnegie Mellon University. Professor Baruch Fischhoff, a world leader in behavioural research, and his team have systematically tested the content of our videos for optimal patient comprehension and information retention. For example, we’ve learned that subtleties such as narrator gender and tone can significantly affect how patients understand information about the trial. Professor Fischhoff’s research is continuing this year and will yield important insights to support more patient centric trials.