Considering The Patient Experience Is Critical To Creating A Successful ICF

By Devra Densmore, MPA, founder & principal consultant, Elevate Advocacy

An informed consent form (ICF) is one of the most important documents a sponsor can produce for their clinical studies. For many study participants, it is their introduction to clinical research and the first information they have about the study. For every study participant, it is also the road map for what they can expect when enrolling in a study, and it serves as the gate between the participant and the study itself. Whether that gate is opened is often determined by whether the participant understands and feels comfortable with what is contained in the ICF.

If an ICF is not written with the study participant in mind — so that it truly facilitates an informed consent — it may increase the likelihood of a person declining to enroll in the study or influence their potential dropout. This risk becomes greater proportional to the amount of distrust a person and their advisors (i.e., family, friends, other healthcare providers) have of clinical research or the healthcare system. Therefore, it is critically important for study participants, particularly those who are unfamiliar with clinical research and who may also be historically underrepresented in clinical research, to have a clear understanding of

• what will be expected of them,
• what will be done with and to them,
• their rights, and
• the study sponsor’s and site staff’s responsibilities.

Despite how important the ICF is and the need to “get it right,” many sponsors do not seek advocate or patient input before finalizing and submitting an ICF to an IRB. Often, it is only key opinion leaders’ (KOLs) insights and feedback that influence key study documents; while KOLs have expertise on the potential scientific and clinical benefit of a study drug or device, the patient is the expert in their perceptions, fears, motivations, and needs to ensure physical and psychological safety and long-term engagement. If those personal factors that could impact study entry and participation are not clearly addressed in the ICF, a trial participant may not fully understand what is required and feel confused or coerced.  

Therefore, every study sponsor or CRO should have advocates, patients, or care partners review an ICF as early as possible to begin adjusting the language, even that which is templated, and to identify areas of optimization or aspects of the study where a risk mitigation strategy may be needed. Additionally, it is recommended that a sponsor have:

• multiple reviewers (at least three per round of review),
• one reviewer who is trial naïve,
• one reviewer who is trial savvy (either as a trial participant or in designing a trial), and
• diversity among reviewers based on backgrounds and geographies. (This is particularly important with global studies.)

It is also important to optimize how reviewers are engaged and empowered to provide feedback. To ensure security around information-sharing, while facilitating independent communication, sponsors may wish to consider partnering with companies to build global, secure platforms that are fit for purpose and offer multiple unique features and capabilities. For sponsors who may not have the budget for a bespoke platform, there are online options that are also secure but have fewer capabilities and require more manual data collection and collation. Limited resources should not result in limited patient engagement, as there are many ways to ensure ICF review can happen regardless of the size of a budget.

Once a platform has been identified, it will be necessary to create an environment in which reviewers have the tools needed to provide valuable feedback and insights. It may behoove a sponsor to consider independent, asynchronous review of the ICF so that each reviewer can review at their own pace and without distraction or bias. Instructions should be clear, accessible, and available for future reference and include a contact person for the reviewer to ask questions or report technology issues. Then, allowing enough time for reviewers to carefully go over the ICF is essential. Many ICFs can range from 10 to 30 pages of dense text. Allowing reviewers at least one week to review the document and provide comments mitigates stress and the pressure to rush through the process. Lastly, sponsors should provide an honorarium to each of the reviewers for their time and feedback. Underestimating the time needed to review a document is common, so sponsors should consider 30 minutes per page of review to determine fair market value.

Should companies wish to leverage templates or guides created by other trial sponsors, resources like The Universal Patient Language, led by Bristol-Myers Squibb, are available and open source. Through examples and downloadable tools, rules, and style guides, UPL provides patient-created recommendations any sponsor can incorporate into their patient-facing materials, including ICFs.

It can be easy to forget that, in clinical research, a person who enters a trial is approaching the experience without the years of planning program teams have or the months of protocol reviews and training sites undergo. Study participants do not have the same deep level of understanding or sense of ownership the sponsor has around the science and potential of the drug or device. Within a matter of hours, days, or weeks, participants are deciding whether to entrust their bodies to a study and often a new group of healthcare providers. Their decision is often a leap of faith that can be very scary. It is with this lens that Elevate Advocacy asks clinical development teams to consider the intelligibility of their ICFs and seek insight and feedback from patients and advocates to ensure the study has a form that facilitates real informed consent.

About The Author:

Devra Densmore is the founder and principal consultant at Elevate Advocacy. Elevate Advocacy partners with drug and device sponsors to de-risk programs by effectively engaging with advocates, patients, and care partners. With decades of experience engaging diverse communities around health education and clinical research, Elevate is a leading advisor in strategic patient advocacy and engagement.