Guest Column | September 20, 2018

Beyond Informed Consent — How To Better Engage Millennials (And Others) In Clinical Trials

By Mary K.D. D'Rozario and Nazneen Qureshi

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Millennials aren’t kids any more — as the oldest members of the generation enter their 40s, they are a large portion of clinical trial patients and study coordinators. In addition to their expectations for context and purpose in everything they do, they’ve grown up with a new level of information sophistication. The companies developing new healthcare products for them have implemented a lot of the pieces of the puzzle of how to serve them better; unfortunately, disconnects in how those pieces link together to track the entire patient journey reduce the effectiveness of those efforts.

The informed consent form is the primary source of information the patient receives about the clinical research journey. It tightly focuses on content surrounding the visit schedule and associated legalities. While these are important pieces, patients are most intrigued by the medication and the effect of it on their condition. Patients want information on the mechanism and scientific background of the medication, an educational piece that is empowering to the patient.

Patients do not frame their experiences of the study based on study visits, but rather the impact of the study on their lives. As they envision what their patient journey will be like, they are best reached by content that frames the experience from their perspective. Just as when a person purchases a car, they don’t want to hear from the car company, they want to hear about the experience of other drivers.

Important parts of that shared experience occur outside the bounds shaped by the informed consent form and informed consent process.  These parts occur before the patient and the study come together and after the patient leaves. As disheartening as the results of this disconnect are — reduced engagement, reduced retention, patients that don’t finish studies, some unknown effect on the success of the marketed product — the exciting thing is that many sponsors now have the elements available to finally complete this loop. The industry is ready to communicate the shared patient experience in a continuous flow from discovery through to marketing.

Engagement Is Critical To Success

Sponsors are more engaged with patients than they have ever been. Patients now attend healthcare specialist and industry conferences on their own or through programs such as Patients Included. Representatives from companies go to patient conferences. Patients are invited to focus groups to provide feedback on the protocol. Despite all this effort to engage the patient, when the study coordinator and the patient sit down for the actual consent process, study coordinators often don’t have that information to share. This lack of communication impacts the patient decision to participate.

The study coordinator wouldn’t know that the sponsor company has sent a representative to a national meeting for patients with the condition, a meeting of patient influencers who may have been advocates for decades. Nor are they aware that a patient focus group has specifically reviewed this protocol and made recommendations that were incorporated into the final study plan.

All these activities are carried out because it has become clear that patient engagement is important to study success, but the excitement of that engagement isn’t transmitted to the study coordinator and on to the patient.  The study coordinator isn’t in a position to speak to study considerations and tell the patient that people just like them were involved in developing this study.

As patients decide whether to participate in a study, they have access to more information and misinformation than ever before. The study justification may still be something that scientists and statisticians write for other scientists and statisticians, but it is becoming much more important at the site level. At Investigators provide training to study coordinators based on the investigator’s brochure, but they often know they have not been given all the relevant information.

The effort put into patient engagement means that companies know what questions to expect from patients. The site staff need to have that training at investigator meetings and site initiation visits. This information directly impacts the ability of site staff to consent and retain patients.

Sponsor company patient engagement efforts also surface what scientific misinformation needs to be countered. It generally isn’t a good idea to confront scientific misinformation directly; however, companies can prepare educational materials that counter this misinformation.  The patient is already empowered by the information they are able to obtain from their community. Completing the circle requires empowering the study coordinator to make the connection between the science and the patient’s questions. Sponsor companies can affect this by sharing effective communication tools backed by legitimate science.

This brings in another piece of the puzzle: the marketing team. Many sponsors have professionals in place who understand the patient community and how to successfully communicate with them. After the product completes the clinical phase, they are poised to launch some of the best advertising of any industry. Why aren’t these teams brought in earlier?

Not only can they develop effective communication materials, they can establish a relationship that bridges the divide between clinical research engagement and product availability for the patient and their care providers once the research phase has ended. This team is aware of the most effective communication channels for specific therapeutic areas and conditions and where people go to find support.

Don’t Forget About Retention

Once the patient has chosen to participate in a study, “retention” becomes the buzz word. But this focus is disconnected from the patient journey thus far. Engagement drives retention. If the patient is engaged in a way that is meaningful to them, retention will take care of itself. Filling out retention logs isn’t retention; the patient feeling that the study is an important experience for them is retention. Yet investigator meetings almost always have a session on how to fill out the retention log and rarely have a session on engagement.

Patient-centricity, which is shaping the approach of both sponsor companies and sites, has not yet reached the investigator meeting. It also has not yet reached the site study budget. One solution is to negotiate to have advertising money moved to items that directly impact the patient experience. If the site can get the patient experience right, everything else follows.

That patient experience follows through to a study exit process that completes the cycle of engagement and ensures the continuity of the relationship with the patient. Results sharing is an important part of the exit process. Currently, if a patient is on a blinded study and happened to receive placebo, they are frequently left to walk away from a study thinking they may have had the product experience. And with the power of social media, how many people are they going to share that experience with? It is in everyone’s interest to empower patients as much as possible with a study debriefing experience.

Exit interviews are also important to get feedback on how to improve the patient experience. The product is going to get the most intensive exit interview of all time in the regulatory agency approval process, but the patient often walks out the door without being asked a single question. Making this a real priority includes outsourcing these interviews to another entity; sometimes the staff from another clinical site can be called in, to get unbiased feedback.

Frustrations with patient engagement are an old story in clinical research, but true progress is here. Sponsor companies have put in the effort needed for true patient engagement and have the pieces in place. What remains is to appropriately link these pieces to the site to make the patient journey complete.

About The Authors:

Mary K.D. D'Rozario is the president of Clinical Research Performance, Inc., providing content development and social media management to companies in the life science space. She previously worked in clinical operations at several CROs. D’Rozario has a master’s degree in clinical research and an MBA, and holds certifications from ACRP, RAPS, and SoCRA.



Nazneen Qureshi is the manager of patient engagement at LMC|Manna Research. In this role, she manages study start-up activities, focusing on recruitment and retention strategies. Her objective is to increase the understanding of patient perceptions to improve clinical research processes such as study design, experience, and motivation to participate. Qureshi is the recipient of the SCRS 2017 Site Patient Recruitment Innovation Achievement Award.  She holds an HBSc in neuroscience and psychology from the University of Toronto and is completing her MBA at Lazaridis School of Business & Economics.