Are Patient Surveys The Missing Link To Successful Recruitment & Retention?
By Ed Miseta, Chief Editor, Clinical Leader
While patient recruitment and retention have been an issue in the delay and expense of clinical trials for decades, patient centricity has at least temporarily moved to the forefront in the clinical space. Although often discussed as two separate issues, there is no question the two are intertwined. Integrating the patient voice in the protocol design process will certainly lead to better recruitment outcomes and patients who are more willing and able to adhere with a study for its duration.
Still, for many companies, figuring out how to get that patient voice involved in the planning process is a major challenge. There are legal and regulatory concerns around actually bringing patients to the table, and advocacy groups may not always be able to deliver the feedback and information you desire. Additionally, obtaining feedback from patients after the trial has concluded is often times completely non-existent.
Jill Eichele knew this was a problem when she and co-founder Charlie Speno launched Patient Perspectives LLC., an evidenced-based research company dedicated to providing actionable insights from the patient. Their goal in founding the company was to find a better way of incorporating patient feedback into the trial design process at sponsor companies and CROs. Eichele had spent a total of eighteen years working in patient engagement, including serving as director of the Global Patient Recruitment and Strategy group at PAREXEL. But more importantly, 10 of those years were spent serving as a director at market research group Harris Interactive, better known for the Harris Poll, where she developed focused research solutions across all phases of clinical research. During that time, she was also instrumental in developing the first online direct-to-patient recruitment campaign.
“If I learned anything from my experiences in recruitment and retention, it’s that sponsors and CROs spend a lot of time talking about centricity and patient involvement, but still have a long way to go,” says Eichele. “We started Patient Perspectives to help industry get the feedback they need, which I believe will help them move the needle in terms of recruitment, retention, and satisfaction issues.”
Determine Concerns Before Writing Protocols
Patient Perspectives uses qualitative and quantitative market research methods to gather insights from patients, caregivers, site staff, and investigators. The purpose is to integrate that feedback into the protocol design process and help clinical researchers identify and avoid many of the pitfalls they often encounter. Respondents (patients) are identified through panels of people who have opted to receive survey invitations online. In some countries respondents are first recruited by phone and then instructed to go to a URL to complete the survey. The panels are segmented so as to identify the demographics of the audience. This allows companies to target individuals by condition, age, race, sex, location, and other pertinent factors. Eichele will also perform outreach to other potential candidates via social media as necessary.
According to Eichele, the industry has gotten to the point where the clinical trial processes have been commoditized. Clinical trials no longer seem to be about the patient, but instead dollars and timelines. While she acknowledges those factors are important, the patients are repeatedly overlooked. As a result, she opted to leave the corporate world and pursue a solution.
“The key to making a trial patient-centric is focusing on knowledge, attitudes, behaviors, and motivations” says Eichele. “We ask patients hypotheticals, such as how willing they would be to participate in a trial under certain conditions or with various requirements. We take those results back to the sponsor and inform them of which aspects of their protocol they might want to reconsider, or how they might want to better educate their sites to handle the impending hurdles.”
Surveys can range from the very simple to the much more complex, although Eichele notes the more complex surveys provide more in-depth information and are more valuable to sponsors in their development efforts. The surveys are generally broken down into sections or chapters depending on the needs of the client. The first chapter evaluates screen failure rates by assessing inclusion and exclusion criteria such as age, diagnosis, concomitant medications, comorbid conditions etc. This line of questioning allows clients to validate their predicted screen failure rates and/or exclusion criterion that disqualify the respondents.
The next chapter attempts to determine what interviewees know about clinical trials, if they have ever participated in one, and under what circumstances they might be willing to participate. In the third chapter respondents are provided with hypothetical situations and asked how likely they would be to participate under certain conditions (the number of visits, the number of weeks, the average time in clinic, medical procedures, etc.). An assessment of their willingness to participate is then produced based on the requirements of the trial.
You Want Me To Do What?
“As clinicians dealing with issues that come up every day, we can tend to forget or not focus on those things that might be very important to patients,” says Eichele. “It can also become easy for us to gloss over the details when speaking to potential subjects. If we can stop and listen to them, we will find that they are often telling us what is important to them. We just have to be willing to listen. My favorite recent quote is “…Your cancer is not my cancer. Hear my voice.””
Eichele gives an example of the importance of listening to concerns of the patient. In one survey, women were presented with the need to take regular pregnancy tests. While most respondents did not have a problem with the requirement, a significant number did note they would not be willing to participate in the trial for that reason. Upon closer inspection, she noted these were women either suffering with infertility issues or otherwise unable to become pregnant. “I have a history of infertility and you’re going to ask me to take a pregnancy test?” asked one respondent. Until further explained, these women did not understand the need to undergo pregnancy tests.
Perspective patients also pay attention to, and have thoughts on, the media used to present trial opportunities to them. For that reason, Patient Perspectives also performs media concept testing. In this case, survey questions focus on media messaging, taglines, images, and communication methods that resonate with the patient population. “We fielded an asthma study where 50% of the respondents hated the media concept while the other 50% approved. “The sponsor ultimately ended up contracting their vendor for two different media concepts to try and garner the most interest from the patient population.”
Surveys can also be used to test informed consent language comprehension. Since this feedback takes more time to complete, it is generally performed via a separate survey. In conducting this research, Patient Perspectives will have individuals read part of an informed consent agreement and then test them on what they read. The results can provide sponsors with a wealth of information about what is and is not understood.
When Was The Last Time You Thanked A Patient?
Finally, Eichele is performing surveys of patients and sites post-study. “When was the last time someone from a sponsor company thanked a patient for participating in a study even if via a third party?” she asks. “When was the last time we asked them what they liked and didn’t like about a trial or a clinical site? Quite frankly, no one is going back to patients when they have completed a study, or dropped out of one, to thank them and get their participation insights. We believe obtaining satisfaction information from patients and site staff is just one small step in giving back to those people that allowed the trial to take place. There is not enough emphasis on obtaining feedback and improving the next patient experience.”
Performing post-study surveys are valuable to sponsors and CROs as well. The feedback received can be contributory in designing future studies by identifying the best performing sites in the eyes of the patients, the best site conditions, and the preferred treatment requirements that lead to increased adherence. Identifying the performers is information that can be valuable when planning future studies.
Despite the obvious benefits that can be accrued from patient surveys, they are not always an easy sell. The most common objection Eichele encounters is companies that are unwilling to invest. Even when companies commit to the surveys, they are oftentimes unsure of what to do with all of the information they receive. It’s a new territory for most. Still, Eichele notes the concept is gaining traction due primarily to the increased focus by many companies to commit to being patient-centric.
“Without this information, a sponsor could produce a protocol that is simply unacceptable to patients and/or singling out a patient profile that just does not exist,” she states. “This will hinder recruitment or cause a large number of patients to drop out of a trial. The cost of that will be far greater to a sponsor than investing in a pre-trial survey to identify potential barriers. Having to rescue a study by adding additional time or sites could cost a company millions.”
Going forward, Eichele believes her company will find success by sharing the evidence she has gathered with sponsors and CROs. That evidence shows surveys affirm what leads to improved recruitment, retention, and participant satisfaction, and she has case studies to further make her point.
“For one of the first surveys we fielded for a client, we received over 3,000 responses within one week. After taking these patients through the inclusion and exclusion criteria, we were left with only one that would have passed the screener. As a result, our client ended up aborting the protocol. That is just one example of the benefit these patient surveys can provide.”