Introduction
Customer feedback surveys are nothing new. For the last few decades, companies across many industries have used them as tools for improving both their products and their perception among customers. With the advent of online survey platforms and near universal connectivity, feedback surveys proliferated.
Pharma has been slow to the party, particularly in clinical development, but in recent years there’s been a gradual but recognizable culture shift within the industry. There’s a growing recognition that the trial participant - the customer - has a lot to say, and that it’s valuable. That trend has belatedly but finally caught on with the clinical trial side of the industry, as sponsors look to draw on the voice and experience of the patient to improve the drug development process and design more cost-effective studies.
There is a unique challenge to collecting actionable feedback from clinical trial participants. Sponsors rely on the sites as their intermediaries and they must get buy-in from the study sites which support the trial. Sites have overburdened staff who may not see the value of the feedback - or, worse, may think the feedback will be used against them by the sponsor. To get the most from this kind of patient engagement initiative, then, it’s important to understand the site’s concerns, to simplify the process to ease any perceived burdens, and to understand and communicate the real value of the data being collected.
The Site Perspective
The growing length and complexity of clinical trials - more procedures, more paperwork - has greatly increased the demands on site personnel. More complex regulatory requirements and stricter regulatory oversight has added to the burden as well, as new processes are added and ongoing compliance training is implemented. The ICH E6(R2) update alone, published in November 2016, adds significant recordkeeping, documentation and other administrative burdens to the site, and these burdens are only magnified by the increasing length of the studies the sites support.
Within this context, it’s clear that any incremental burden will be met with some measure of resistance. Compounding the challenge is the fact that the patient isn’t obligated to complete a feedback survey, and an “optional” study requirement may not be viewed as a requirement at all by the site.
The site may also have another reason for resisting: any good patient feedback survey will certainly include questions that relate to the site experience. The reality is that many patients in a clinical trial don’t know the name of the sponsor; often they don’t know the name of the study itself. The site is truly the “face” of the clinical trial for the patient, and it’s the site staff who are tasked with not only engaging with patients during study visits, but disseminating and explaining consent documents, communicating the details of procedures and compliance requirements, and - maybe most significantly, as the patient’s trusted authority - conveying the importance of everything being asked of the patient throughout the study. A well-designed feedback instrument, then, would necessarily include questions about interactions with the site staff, timeliness of appointments, and the clarity and helpfulness of communication throughout the trial, all of which are major factors not only in the patient’s level of overall satisfaction with the study, but in the patient’s willingness to participate in future studies.
The value of this data for the sponsor is obvious. It provides a measurable assessment of the patient experience, and can serve as a tool to help improve retention rates, drive down study costs, and design better and more patient-friendly programs. Patients benefit from better-designed trials that fit their needs, along with the lower drug costs that may follow.
There is a real and obvious value to the study sites as well, in the sense that the feedback can help them target opportunities to improve the care they provide to their patients and opportunities to improve communication and overall patient support. But perceptions about how the feedback will be used, and by whom, make the issue less clear-cut.
When we asked site administrators in 2015 about the prospect of collecting survey feedback from their study patients, most had a positive opinion. Few had implemented a trial participant experience survey at their own site, but the majority agreed that it was a necessary and valuable tool for improving site/patient relationships, helping with retention and compliance, and nurturing a patient-centric philosophy at their practices.
Yet, in a pharmaceutical company site survey we fielded two years later, following a patient feedback survey initiative for a sponsor which gave sites the option of participating, feedback from the sites showed that a number of them resisted simply because they saw no utility in the patient perspective. Two examples of the comments we received: “I don't think the study subject should be treated as a VIP,” and “If you want to know what patients think, just ask me!”1 Unsurprisingly, these sites chose not to offer the survey to their clinical trial participants because of their views.
Not all sites took such a dim view of the potential value of the patient’s insights and concerns. But site administrators may reasonably ask questions about how the sponsor will interpret the data collected during these surveys. Will a site be “ranked” among other sites, and possibly even be dropped in future studies because of its patient-graded performance? If the survey is optional, isn’t it more likely that only the dissatisfied patients will choose to take it? Will one or two bad responses hurt a site if only a handful of patients are enrolled in a study? Will a site be downgraded for reasons that may be completely out of its control?
Of course, patient feedback about the site can be a tool for evaluating a site’s effectiveness at conducting the study on behalf of a sponsor. Sponsors want to know why patients may be more satisfied at one site than another, or why a site is well-suited for studies in one therapeutic area but not another. Improving the level of care for all patients, and matching the right sites to the right studies, is a legitimate and important goal.
Trial participant experience surveys, obviously, are not solely about the site experience. They are also, and more accurately, tools for understanding the drivers of patient satisfaction and for addressing issues that have long been problematic to patient recruitment and retention. By utilizing trial participant surveys, sponsors are able to better understand the patient perspective regarding on-going study visits and procedures, completing assessments, the informed consent process, transportation and travel burdens, study tools and technology, and how all of these support or inhibit trial design and execution.
A good strategy for implementing a patient experience survey, then, will simplify the process of delivering surveys for the site, and also allay concerns the site may have about the use of the data, while ensuring a robust set of responses that will allow for informed and well-supported decisions about study design and implementation.
Simplifying Implementation
In order for any new, disruptive advancement in clinical trial operations to occur, those responsible for adoption have to simplify implementation and create the perception of minimal burden on key stakeholders. For the trial experience survey, specifically, a tool still at the early stages of use throughout the industry, it is important to recognize that most sites have never provided an anonymous study satisfaction questionnaire, and don’t yet have the processes in place to support its implementation among their patient populations and within their clinics.
While training initiatives and clear and concise communications are important aspects of successful utilization, there are other, more technology-based and study planning tactics that will ensure success, including:
- Ensuring access across all of a patient’s devices (smartphones, tablets and laptops)
- Integrating into existing study technologies, such as ePRO devices and patient engagement portals
- Leveraging text messaging capabilities to notify patients, get faster on-site opt-in from the patient, and deliver survey links with minimal impact on the site
- Providing exposure of survey links on all patient materials (patient study guides, visit reminders, informed consent forms, patient retention materials, etc.)
- Including survey tasks within CRO and site contracts
- Including survey assignments within protocols and visit schedules Conclusion
The culture shift within pharma to embrace the value and even the necessity of hearing the patient voice is in the early stages even now. Sponsors still remain focused primarily on the front end of the development cycle, incorporating insights into protocol design before a study is even launched. Few sponsors have a reliable way to measure, in hindsight, how a supposedly patient-centric study actually performed. Feedback from the participants who either complete or drop out of a study illuminates the unanticipated hurdles to participation that weren’t identified during the study design process, making it an invaluable tool for the industry as it moves forward.
In order for that to happen, sponsors need to recognize the sites as partners, and be cognizant of both the unique burdens they face and their role as the trusted face of the study. Sponsors need to share not only the context of what they’re trying to do, but the philosophy that drives it, and the understanding that the patient experience is entwined with the site experience. Doing so, addressing those burdens and building a holistic approach with the site as an active partner, will do more than improve survey response rates. It will communicate the message that the sponsor and the site are working together to advance the level of care, to optimize the patient experience in every sense, and to benefit all by leading to better trials, a better site experience, and happier patients.
References
- Cambridge Healthcare Institute, SCOPE Conference. “Implementing a global patient satisfaction survey: A Case Study.” Hartog, Steel. January 26, 2017.
Ms. Steel is the CEO of HealthiVibe. With over 25 years of experience working in the life sciences industry, leading clinical development and post-marketing programs, she founded HealthiVibe out of a passion for patient engagement and a commitment to improving clinical and commercial development programs. Ms. Steel previously worked at UBC, Sanofi and PAREXEL. She received her Masters in Health Communications from Boston University and her BA from George Washington University.