(This is part 3 of a 3-part series on Inflammatory Disorders Studies. View part 1 here.View the complete series in our Inflammation eBook.)
Patient-reported outcomes, compliance and retention are key components of success.
Recent research contends some underlying immune system response mechanisms are common to inflammation-related diseases, such as asthma, COPD, psoriasis, rheumatoid arthritis, lupus and inflammatory bowel disease. These diseases are referred to as Immune-Mediated Inflammatory Disorders (IMIDs). There is a significant shift in the approach to managing traditional inflammatory diseases from organ-based symptom relief to tackling common underlying pathways of immune dysregulation which offers the hope of disease modification.
This shift translates into an opportunity for pharmaceutical companies to develop new treatments specifically geared toward modifying disease states, entering new markets and expanding market share. Although IMID trials are known to face a number of challenges that could easily derail efforts, there are ways to proactively address and reduce these challenges. A number of these ways are associated with the role of the patient – here we focus on patient-reported outcomes, patient compliance and retention.
Manage use and integration of patient-reported outcomes (PROs)
PROs play a major role in many inflammation diseases because of the subjective nature of symptomatic improvements in treatment outcomes, such as lessening of joint pain. Misapplication of poor or out-of-context PROs can lead to incomplete and/or spurious data.
To effectively prepare for this challenge, pharmaceutical companies can work with their CROs to carefully select and manage implementation of the appropriate and validated disease-specific PROs. Ideally, this entails integration between clinical development, health economics and outcome research teams, leveraging their collective expertise and experience. The approach provides the following benefits:
- Clear instructions about expectations for questionnaire or other PRO instrument completion
- Clear instructions for site personnel to review each instrument as soon as possible after administration so any missing data or clarification can be addressed swiftly
In addition, use of an electronic device for data capture can expedite real-time data capture and integration into the database and minimize errors.
Proactively address patient compliance
Many of the new therapies to address inflammatory diseases are biologics administered by injection. Self-administration of an injectable drug; however, poses several issues, including patient apprehension and poor technique, and can lead to non-compliance and reduced drug efficacy.
Training and continual technique checks are critical to increase patient comfort and compliance with self-administration. During the screening period, placebo doses can be used and observed in the clinic or screening/randomization sites.
Optimize patient retention
Success doesn’t end with recruitment; the patients need to be retained as well, especially when the study requires a long-term commitment, such as rheumatoid arthritis studies with endpoints focused on radiographic response and/or physical function that requires patient follow-up for up to two years.
The following are ways to increase continued patient participation:
- Leverage pre-existing patient relationships—For indications that are chronic conditions, as such, the majority of patients entered into clinical studies will be already known to investigators. Investigators will have direct involvement with patients and family members during each visit.
- Educate patients on an ongoing basis—Provide patients with general study updates and health-related information.
- Send study reminders—Using postcards or text messages, communicating with patients prior to scheduled appointments can keep commitments top of mind. Visual reminders, such as magnets, calendars and notepads can also be effective.
- Telephone contact—Site staff can phone patients between scheduled appointments to check on well-being and protocol compliance and remind patients of their next scheduled visits.
By taking these steps with patients, you can effectively address the clinical trial challenges IMIDs face.