Author: Amanda Howley, Director, Services Delivery
Snapshot:
- Enhanced Patient Understanding: The FDA draft guidance emphasizes the importance of clear, concise communication in informed consent, suggesting tools like summary sections, multimedia formats, and glossaries.
- Supporting eConsent Compliance: Suvoda eConsent aligns with the FDA’s recommendations by incorporating tools that improve patient comprehension, such as videos, cross-linked glossaries, and discussion threads.
- Organizing Information: The guidance suggests organizing consent information to cater to diverse patient needs, enhancing understanding and informed decision-making.
Informed consent serves as a fundamental pillar of ethical clinical trials, ensuring that prospective participants possess a comprehensive understanding of their involvement.
As clinical trials evolve, so too must the informed consent process. The integration of eClinical technologies into this process stands to improve patient comprehension, driving the need for regulatory updates that reflect these advancements. As a result, Contract Research Organizations (CROs) and sponsors must continually adapt their processes to remain compliant while prioritizing patient comprehension.
In March 2024, the FDA published a draft guidance, aiming to enhance the informed consent process by highlighting the criticality of patient understanding. The key takeaway from this guidance is the need for informed consent processes and emerging technologies to focus on ensuring that patients truly comprehend the information presented.
In a previous blog post, I explored how consent management tools can facilitate this understanding, creating a win-win scenario for patients, sites, and sponsors alike. This blog delves deeper into the FDA’s draft guidance and highlights how Suvoda eConsent aligns with the recommended essential components for patient consent forms to promote better patient comprehension.
Key takeaways from the FDA guidance
The draft FDA guidance suggested several strategies for effectively communicating consent information, whether in written, oral, or electronic formats. It discussed the need for clear and concise presentation through different features in the forms, such as the incorporation of a summary section.
The draft guidance recommends the following elements:
1) Summary section
One of the specified requirements in the guidance is the presentation of summaries. A patient consent form should begin with a concise presentation of key information, along with an introductory statement to frame the key information.
Aside from key study information such as study duration and requirements, the guidance also recommended that researchers highlight information regarding the most common and serious risks and discomforts to encourage informed decision-making.
By providing a clear introductory framework, consent forms can help break down complex information into digestible formats, aiding patients in grasping the critical aspects of a study without feeling overwhelmed.
2) Video & alternative media
The draft guidance also suggested incorporating alternative media, such as illustrations and videos in consent forms. Suvoda eConsent, for example, allows for a mix of media formats to be included to increase accessibility and patient comprehension.
These formats can highlight the most significant information right at the beginning of the document. For specific studies and varied participant demographics – considering participant age and reading level, for example – trial teams can include additional content or design elements to cater to their needs.
Additionally, essential study information can be reiterated to foster clarity. For instance, a consent form might restate medication side effects both as a bulleted list on the summary page and as an infographic in subsequent sections.
This method of repeating information, especially through diverse media formats, accommodates various learning styles, since visual storytelling aids in reinforcing critical messages.
3) Cross-linked glossary
Participants may find scientific and medical terminology daunting. Consent forms that include a cross-linked glossary, directing prospective participants to the relevant sections, can aid in comprehension.
For instance, Suvoda can add hyperlinks to provide detailed information on study risks directly from the key information page in Suvoda’s eConsent forms.
The draft guidance also suggests that trial teams arrange the consent form in a tiered format: key information should appear first, followed by supplemental data, and finally optional glossary terms. Related terminologies can cluster together in bubbles or defined borders to facilitate easy comprehension.
A well-organized glossary supports informed decision-making by granting participants easy access to supplementary information, allowing them to explore terms relevant to their healthcare journey at their own pace.
4) Discussion threads or questions from participants
In consent forms, participants are encouraged to communicate with their healthcare team if they have questions regarding the informed consent document. In line with this, electronic consent solutions should incorporate a discussion section that fosters communication between participants and study sites. This feature is available as part of Suvoda’s eConsent solution, facilitating discussions to clear up any possible questions patients may have.
A discussion thread is meant to enable participants to jot down notes and facilitate conversations with the trial team, clarifying any information they wish to explore further. This improved accessibility can significantly enhance participants' understanding of the information provided.
Organizing consent information to improve participant comprehension
Beyond the recommended elements in a consent form, the draft FDA guidance also emphasizes the critical role of information organization in enhancing comprehension. The way trial teams structure information can directly influence patients' understanding.
Before crafting the consent form, trial teams can conduct a needs assessment of the target population to determine the optimal flow and presentation method for the information, considering factors such as age, literacy levels, diagnosis, and cognitive abilities.
Organizing and presenting consent information in a patient-centered manner is the next step. The integration of plain language alongside visual aids—like diagrams and images— helps to improve patient comprehension.
Overall, informed consent information should strive to convey more than isolated facts; it should communicate the reasons why patients might choose to engage in or opt out of participation. A carefully organized consent form, tailored to diverse participant needs, is fundamental to better comprehension.
Transforming clinical trials: the future of informed consent
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