Tips to strengthen clinical trials by improving the patient experience

From consumer products to clinical trials, anything that is designed without input from its intended recipients will likely feel disconnected from their needs. Conversely, systemically gathering their feedback and incorporating it into the design can increase their interest and trust.

Consequently, sponsor companies that take a patient-centred approach to study designs may find that it goes a long way toward raising general trust in the pharmaceutical industry. They may also find it easier to enrol, engage, and retain patients in clinical trials that adequately accommodate their real-life needs and preferences. Improved enrolment improves trials, ultimately benefitting patients by bringing better medicines to them faster.

The question is how to capture patient preferences and incorporate them into clinical trial designs without dramatically escalating costs and timelines. To “economically” weave the patient experience into the fabric of clinical trials, sponsors should consider two key factors:

1. Simplification. The more a study can simplify (a) the clinical trial process and (b) the language used to connect with patients, the easier and faster it may be to recruit and retain patients.
2. Optionality. Just as patients are not homogenous, clinical trials should not be homogenous either. A one-size protocol does not fit all patients – especially when sponsors try to reduce barriers and engage diverse patient populations. That means studies must be designed to provide convenient options for participants while maintaining overall integrity and quality.

Although adapting to these two factors does take some intentionality, it does not have to be overly burdensome. Strategies and tools exist to help sponsors streamline the process to build more patient-centric studies. There is no need to reinvent the wheel.

Look at the protocol with fresh eyes

Most patients know little about clinical trial protocols and processes. Even if they understand the clinical trial concept, it’s often difficult for them to determine whether they qualify for a particular study. For example, patients looking for a trial on the clinicaltrials.gov website might read the brief titles and summary descriptions and think, “I don’t know what this means.”

However, sponsors can remedy that situation using freely available tools such as TransCelerate’s Clinical Trial Registration Tool. This solution allows sponsors to copy and paste a protocol description into a built-in assessment tool that generates, in essence, a “readability score.” It flags when the language needs to be simplified by highlighting excessively technical terms, abbreviations, or other issues that might hinder patient comprehension. In other words, it enables sponsors to evaluate a description’s patient-friendliness quickly.

Likewise, sponsors can use sample questions and guides to simplify how they talk and interact with patients and caregivers. By better engaging them during protocol development, sponsors can improve their experience.

Asking the right questions of patients and caregivers may open the possibility of writing a protocol that includes clinical endpoints that matter to the patients. It might also underscore opportunities to reduce their protocol burdens and simplify their clinical trial experience. All these elements could contribute to patients finding value in trial participation, thus easing recruitment and retention.

Seek insightful feedback

Even with the best protocols in place, unforeseen execution challenges often arise. So, once studies are underway, it’s equally important to assess whether they are continuing to meet the needs of their participants.

After study enrolment, sponsors should consider using other complimentary tools to gather patient perspectives, such as the Study Participant Feedback Questionnaire (SPFQ). The SPFQ is a survey aimed at getting real-time patient feedback to identify potential participation barriers and measure patient satisfaction. It includes three different sets of questions that can be used at a study’s beginning, middle, and end.

Ideally, sponsors who use a questionnaire at the beginning and middle of a study will expand their chances to identify and mitigate any causes of dissatisfaction. By adjusting a study as it progresses, sponsors might improve patient engagement and retention.

Remember that convenience is king

Patient advocacy groups almost always say convenience is the key to an excellent clinical trial experience. Patients may be more inclined to enrol and stay in trials when sponsors prioritise their convenience when considering how to arrange the procedures. For sponsors, this means recognising how the disease being studied shapes patients’ lives.

For example, if a disease affects patients’ mobility, they may be less willing to participate in a trial that demands multiple in-clinic visits. They may be more willing to participate in a study that accommodates their mobility limitations by enabling home, virtual, or decentralised visits. Better yet: it allows them to choose the home, virtual, and decentralised options that best fit their needs.

Keep in mind that, while decentralised visits, home visits, virtual visits, remote monitoring, and other modernised study adaptations may be desirable for some patients, other patients may have reasons for wanting to go to a traditional study site. Some may be willing to attend on-site appointments, but need assistance with childcare or transportation to do so. Similarly, while some patients may be able to participate in a study during the week, others may need to participate on weekends.

All forms of engagement help, but what truly impacts patients is having options that let them seamlessly integrate study participation into their lives. Offering options can certainly add some complexity to a study’s design – especially for sponsors accustomed to creating and running trials in a single, uniform manner.

With the appropriate upfront planning and tools, patients can enjoy more options that simplify and improve their experience. That, in turn, will undoubtedly strengthen research results for everyone.