In today’s exceptionally crowded clinical trial environment of inflammatory bowel disease (IBD), patient-centric practices can help your study of Crohn’s disease (CD) or ulcerative colitis (UC) stand out to both patients and sites. Learn about your options to increase your trial’s patient centricity, encourage recruitment and promote ongoing patient retention.
Incorporating the Voice of the Patient (VoP)
Collecting and applying the VoP to align and integrate the patient into a study has become an increasingly important factor during study planning. Through Labcorp, the diagnostic business and the parent company of Covance, we have surveyed patients to learn about their willingness to participate in a study. Here are a few critical factors we found:
- Providing access to study drug after the study completes is a key driver for patient participation.
Seventy-two percent (72%) of UC patients and 66% of CD patients were more willing to participate in the study if the study drug was available after study completion.
- Patients’ time is important to consider for additional clinical visits.
When considering additional clinical visits per month, over and above standard of care, 94% and 84% of IBD patients are very or somewhat accepting of one or two additional visits per month, respectively. However, the acceptance rate falls to 55% with three additional visits per month. Similarly, when considering the number of additional hours beyond a regular clinic visit, 93% and 63% of IBD patients are very or somewhat accepting of one or two additional hours per clinic visit, respectively, but this drops to 36% with three additional hours per clinic visit.
- Travel distance to a study site matters.
A distance of 25 miles or less is considered the optimal distance a patient is willing to travel to an investigational site. Assessing the radius of a potential site’s referral network during site qualification is, therefore, an important factor.
The role of Patient Reported Outcomes (PROs)
Sponsors should consider measuring outcomes within their studies that are important to patients – a topic neatly discussed by Bojic et al1 and Dür et al2. A plethora of PROs are utilized in IBD studies, often with little consistency. Obtaining patient feedback and working with patient advocacy groups during protocol development can identify those PROs that appeal the most to patients and that will ultimately optimize product labeling.
However, when deciding which PROs to include or exclude, sponsors must ensure compliance with relevant regulatory guidelines3,4,5 and ensure that the PROs are translated and validated accordingly.
Incorporating virtual/hybrid study design elements in IBD studies
With the requirement for colonoscopies and biopsies, it is unlikely that IBD studies will ever become fully virtual, but a hybrid approach may be a possibility. Figure A provides an analysis of a typical Schedule of Events (SoE) for a UC study, indicating which aspects of the protocol can be achieved on a virtual basis, including the following:
- Blood sample collection – Provision of global solutions for local sample collections to reduce travel to investigator sites. Options include home health visits, partnerships with local retail pharmacies and convenient patient service centers (PSCs)
- Adverse event collection
- Vitals collection – Mobile apps and connected device/wearable sensor solutions to streamline data collection
- Televisit/Telemedicine – “Face-to-face” physician/patient consultation with study-specific, secure apps on smartphones, tablets or computers.
- Electronic PROs (ePRO)
Figure A: Analysis of Example UC SoE Conducive to Virtual Completion
Achieving higher compliance with informed patients
Standard patient consent processes are not particularly patient-friendly. Being provided with a document typically about 20 pages long is daunting for even the most literate of patients.
Electronic consent (eConsent) offers a significantly more patient-focused approach to the consent process. It offers patients access to study portals, digital media explanations and links to relevant information, which ultimately allows them to make a more informed decision, often in the comfort of their own home. A more informed patient is often a more compliant patient.
Providing patient communication and education
Beyond being simple, inexpensive and courteous, patient communication represents an essential element of patient-centric trials. As an industry, we should provide the patient with study updates throughout the study, obtain feedback regarding the trial experience to enable the application of lessons learned in future studies and even share a summary of the study results (in layman’s terms) in addition to informing the physician of which treatment the patient received (in a blinded trial).
Study-specific applications can support informing and communicating with the patient. For example, an app can include a Study Guide that outlines what will be done at each clinic visit, dosing instructions and provision of patient reminders about pre-clinic visit requirements together with appointment reminders. Continuous education can be supported with periodic uploads of new materials.
A strong collaboration with patient advocacy groups, a trusted source of information for patients, also enables an effective means of initially increasing awareness about your clinical trial among the patient community and subsequently providing additional educational materials.
Looking ahead in a competitive IBD environment
To succeed in today’s IBD environment, we must fully embrace patient (and site) centricity rather than just talking about it. By evaluating and incorporating resources local to the patient, such as pharmacies, PSCs and technology, we can ease the burden of study participation for all stakeholders.
- Daniela Bojic, Keith Bodger, Simon Travis. Patient Reported Outcome Measures (PROMs) in Inflammatory Bowel Disease: New Data, J Crohn’s Colitis, Volume 11, Issue suppl_2, 1 March 2017, Pages S576–S585, https://doi.org/10.1093/ecco-jcc/jjw187
- Dür M, Sadloňová M, Haider S, et al. Health determining concepts important to people with Crohn’s disease and their coverage by patient-reported outcomes of health and wellbeing. J Crohn’s Colitis. 2014;8(1):45–55. doi:10.1016/j.crohns.2012.12.014
- Guideline on the development of new medicinal products for the treatment of Crohn’s disease. CPMP/EWP/2284/99 Rev. 2
- Guideline on the development of new medicinal products for the treatment of ulcerative colitis. CHMP/EWP/18463/2006 Rev.1
- Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry (Draft). United States Food and Drug Administration (FDA)