How can patient-centricity ensure your planned study is feasible? The answer is simple: patient-centric studies are more feasible because they are attractive, convenient, engaging, and understanding of patient needs.
Ultimately, the patient-centric approach addresses many of the challenges related to patient recruitment and retention, which are both significant contributors to the failure of clinical trials. Attractiveness and convenience aid recruitment, while engagement and empathy aid retention.
Patient-centric trials are attractive
A patient-centric approach enables researchers to design the trial in a way that doesn’t simply encourage participation but makes participation an attractive option. Patients have certain expectations when they sign up for a clinical trial and are more likely to participate if the study addresses their needs in some way.1 You may believe in the effectiveness of a treatment, but if the measured outcomes don’t capture what is important to patients, the trial will lack personal meaning for participants. For example, patients may want specific symptoms or adverse effects to be improved by the new treatment, and yet these may not be the focus of the study design. Integrating patient-relevant outcomes into the design, along with the outcomes of importance to researchers and pharma, makes the trial of reciprocal benefit.
In our recent ‘Innovation in Patient Recruitment’ survey,“protocol complexity” was ranked as the biggest challenge to patient recruitment for clinical trials.2 Complex study protocols are not attractive to patients. All patient communications and any information provided must consider the health literacy of the target patient population and there should be established literacy guidelines that are used by all stakeholders for shaping communications with participants. For example, presenting certain information in a visual format or a format that tells a story will help many participants who struggle with literacy to understand the information being communicated.
Informed consent forms can make a trial seem an unattractive option. In particular, they discourage participation if they are lengthy and complicated. Any complex information must be broken down into a concise and understandable format for potential participants. Patients and family members need a clear explanation of trial procedures and any expectations of them before they give informed consent. Without a good understanding of how participation will benefit them, many potential participants are likely to opt out – if not at the beginning, later in the trial once they realize they aren’t gaining anything from their participation.
Patient-centric trials are convenient
Reducing or eliminating the need for patients to attend a physical study site can go a long way towards improving recruitment and retention. The use of digital technologies can enhance the practicality of a study by enabling patients to balance participation with their daily lives. Technology can also reduce the geographical and financial barriers that may hinder participation for those patients who live far from the nearest study site.
If the patient is regularly required to attend site visits, such as when medical tests or scans are necessary, participant burden can be reduced by taking other study activities to the patient. Digital gadgets, such as wearables and sensors, can be used to collect patient information virtually rather than at the clinic. Tele-health arrangements can also be employed for certain interactions.
Patient-centric trials are engaging
Continuous engagement is essential for ensuring that the study team can address patient needs and concerns as they arise, from recruitment until the end of the trial. Clinical outcome assessments (COAs) can be used to measure how a patient functions or feels after undergoing a certain treatment or intervention. This can be in the form of patient-reported outcomes that assess symptoms, treatment satisfaction, impact of illness on activities of daily living, and quality of life, among other outcomes. It is important to use assessment tools that have been developed and validated with input from patients in order to establish “content validity” and ensure the measure is patient-centric.
It is also important to communicate with patients in a way that is both familiar and preferable. With the widespread use of smartphones, text messaging, and apps, there are multiple ways in which patients may prefer to be contacted. Mobile phones can be used to send reminders about upcoming visits, and to provide encouragement for patients to continue participating in the trial. Engagement can be further enhanced through the provision of online study platforms, where participants can ask researchers questions, share their participation experiences, or simply interact with other participants. Such engagement is an opportunity to meet both patient needs and study needs as any problems can be identified and addressed in a timely manner.
Patient-centric trials understand patients
In our survey, “understanding the patient’s perspective” was ranked as the third most important challenge when recruiting for clinical trials.3 To ensure feasibility of a clinical study, researchers must make efforts to understand what patients think and feel about the trial design and the requirements of their participation.
It is important to look beyond protocol eligibility criteria and seek to understand the everyday lives of patients so that you can identify factors that might impact their continued participation in the study.4 This will help with the development of more focused participant personas, which will contribute towards the overall success of the trial.
A comprehensive patient profile, which can only be fully achieved through patient-centric strategies, will enable researchers to understand factors such as:
- How the demographics of the target population may impact participation in the trial. For example, elderly people may have difficulty travelling to a study site, but may also find technology-based, site-less trials daunting.
- How the daily impact of a disease may influence participation in the trial. Patients who are used to routine or frequent doctors’ appointments and hospitalizations are likely to be more comfortable with trial procedures that require site visits and interventions. Conversely, patients who have experienced very few medical interventions may feel overwhelmed by such procedures.
- How socioeconomic status and the potential cost of participation might impact a patient’s decision to take part or remain in a study. An understanding of such factors will ensure participant concerns around time off work or reimbursement can be addressed accordingly.
One of the best ways to gain a deep understanding of the target patient group, and to ensure your study is feasible, is to collect extensive feedback from patients, caregivers, and healthcare professionals.5 Patient feedback surveys, can provide the information you need to accurately assess patient availability, eligibility, and needs. These surveys are a pro-active tool that will help prevent bottlenecks as a study progresses.
It is important not to underestimate the role of caregivers in helping achieve a patient-centric study design. Caregivers can provide a practical view of how the study design will influence the ability of participants to join and remain in the trial. Indeed, they are likely to offer perspectives that were not considered during the initial study design. Nurses often develop a special relationship with patients and caregivers that provides them with much deeper insights into the attitudes, concerns and behaviors of certain populations. Nurse specialists with plenty of experience in working at high-performing investigative sites can provide their thoughts on how a study design might be burdensome to patients. They also understand how the burden of a study is different from traditional clinical care and can suggest possible changes to make the process easier for patients.
Running a mock trial visit can prove invaluable for uncovering potential issues before the study protocol is finalized. This involves working with patients, site staff, and the study team based on how the actual study will be conducted. Feedback gleaned from the mock trial can prevent costly protocol amendments later, while also ensuring a positive patient experience during the real study.
With patient-centricity, everyone is a winner
Patient-centricity is a powerful tool for enhancing the feasibility of a clinical trial. A patient-centric approach ensures a study is attractive, convenient, engaging, and empathic of patient needs – at recruitment and throughout the duration of the study. The benefits to be reaped from a patient-centric approach are reciprocal, offering a win-win situation for everyone involved in making the study a success – with patients being the key players in that success.
To learn how Clariness can help you improve your study planning and help you achieve your clinical aims on time, download our Study Optimization Checklist here: https://www.clariness.com/check01/
- Round, R. and Williams, K. (2018). ‘Achieving patient-centricity in clinical trials: uncovering the mystery.’ Clinical Researcher, 32 (9). Retrieved from: https://www.acrpnet.org/2018/11/13/achieving-patient-centricity-in-clinical-trials-uncovering-the-mystery/ [Accessed 11 January 2019].
- Clariness (2018). ‘Innovation in Patient Recruitment Survey.’ Clariness. Retrieved from: https://www.clariness.com/2018/06/19/innovation-in-patient-recruitment-survey-final-push/ [Accessed 11 January 2018].
- Clariness (2018). Ibid.
- Round, R. (2018). ‘Five Steps to Making Your Clinical Trials Patient-Centric.’ Applied Clinical Trials. Retrieved from: http://www.appliedclinicaltrialsonline.com/five-steps-making-your-clinical-trials-patient-centric [Accessed 11 January 2019].
- Round, R. (2018). Ibid.