Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSClinical trials are an invaluable part of bringing breakthrough treatments to market. However, they are complex, often rife with unknowns and require patients to consent to a myriad of steps and actions that are essential for conducting research. Regulatory bodies around the world (including health authorities and institutional review boards) are appropriately strict about informed consent. This does not equate to simply getting a participant’s signature on a consent form, but truly delivering an understanding of the protocol, its potential benefits, and risks. At its core, informed consent is a process in which participants must:
Despite its numerous proven benefits, sponsors have been hesitant to adopt electronic consent (eConsent) platforms beyond the pandemic. Modern technology adoption and behavior change can be challenging, but the benefits eConsent provides to all stakeholders far outweigh the adoption hurdles.
Here is how an eConsent solution simplifies the trial experience for both site staff and patients.
Most consent products present patients with a high volume of complex paperwork to read, digest and comprehend. By offering vital information in alternative forms such as multimedia and digital glossaries, the patients’ understanding and thereby consent process can be simplified. This digital approach improves participant discussions and the overall quality of the informed consent process. It is beneficial for stakeholders and critical to use in complex consent situations.
In a clinical trial, everything begins with consenting the participant; the first and most important interaction between the clinician and patient. Whether participants enroll in person or online, they are immediately required to complete and sign consent forms.
A well-built eConsent platform can simplify this process by facilitating informed consent for patients both onsite at the physician’s office or remotely from any other location. It keeps participants interested and engaged by offering study details through audio, video, interactive glossaries and more. The goal is to empower participants with digestible, relevant information and enable sites to resolve participants’ specific queries leading to more productive use of their one-on-one time.
With an eConsent platform that offers rich multimedia formats, patients can consume information in the form of explainer videos, audio narration and visuals – from graphics to cartoons and images. This helps translate complex medical jargon into relatable, understandable information that appeals to a variety of learning styles.
Audio and video information is especially beneficial for hearing-impaired patients, while visually challenged patients can be supported with audio narration and adjustable font sizes. Similarly cartoon videos and images are particularly engaging while informing and educating pediatric patients. Interactive glossaries allow patients to quickly access complex medical term definitions.
Once the patient has reviewed all the relevant information, knowledge checks in the form of quizzes ensure that the patient fully understands the scope and implications of the study.
Once patients have reviewed all the information electronically and received the answers to their questions, they can sign the consent form digitally. This form is presented in a tiered format and contains handy features such as call-out boxes for information, command boxes, pictures, and diagrams. For site staff, digital consent is quick and efficient as it eliminates paper, improves patient education and communication, and facilitates document versioning control and oversight.
Furthermore, if patients need to re-consent to any protocol amendments during the study, site staff can promptly and clearly communicate the changes, explain what it means to the patient and secure their signature electronically. All this can be done with participants remotely without creating new in-person appointments to discuss and sign with wet ink. It provides site staff with additional time to focus on unique participant questions and makes the whole experience seamless for all parties across the board.
eConsent delivers a highly simplified trial experience for both site staff and patients – while also generating a return on investment for sponsors. As we see better outcomes in patient engagement and compliance, it is time for the medical industry to embrace more efficient consent procedures altogether.
Stay tuned for part two of this blog series, where I will detail how eConsent delivers returns on sponsors’ investment with this versatile technology.
Interested to learn more on how eConsent benefits sponsors? Visit IQVIA.com/eConsent.
Combine data science, technology, and analytics driven by artificial intelligence to support new efficiencies and business insights -- without additional capital investment.
Ease the burden on your sites and make it easier and more appealing for patients to enroll and remain engaged.
Technology informed by unparalleled Decentralized Trials (DCT) operational experience and delivered at global scale.
Deliver eConsent to sites and study participants around the globe with confidence
