Indicators Your Clinical Trial is Not Patient-Centric

In recent years, the shift towards patient-centric clinical trials has become paramount. A patient-centric approach not only ensures higher patient satisfaction but also improves recruitment, retention, and overall trial success rates. However, many trials still fall short of being truly patient-centric. Here are key indicators (KPIs) that may suggest your clinical trial is not designed with the patient in mind.

1. High Dropout Rates
   • Large number of patients dropping out mid-trial indicates that the trial design or execution has not been crafted keeping the patient in mind. This can be a result of various issues, including complex protocols, lack of support, or unattended patient needs.
2. Low Patient Engagement
   • Very little interaction and feedback from patients indicate that they are not actively engaged in the trial proceedings. This can be due to lack of communication or opportunities for patients to provide input.
3. Complex and Burdensome Protocols
   • Patients find the trial protocols over complicated or time-consuming, and this can negatively impact participation and adherence.
4. Lack of Diversity in Patient Population
   • The trial does not reflect the diversity of the patient population it aims to serve, which limits the generalizability of the results.
5. Insufficient Communication with Patients
   • Patients feel they are not properly intimated about the trial’s progress or the role that they play, leading to confusion and dissatisfaction.
6. Poor Patient Feedback and Satisfaction Scores
   • Negative feedback from patients about trial experience is a direct sign that the trial is not in alignment to their needs.
7. Limited Use of Digital Tools and Remote Monitoring
   • Reliance solely on traditional means without leveraging eClinical tools can make participation very challenging and make the trial not so appealing for the patients.
8. Inadequate Support for Patient Advocacy
   • If patient advocacy groups don’t get involved in the trial process, it indicates that there is a gap in understanding patient needs and perspectives.
9. Rigid Trial Designs
   • Inflexibility in adapting trial protocols based on patient feedback and needs can result in a poor patient experience and lower participation rates.

How to Correct These Indicators

Addressing these indicators is crucial to ensure that clinical trials are designed and conducted with the patient in mind. Here are strategies to correct these indicators and enhance patient-centricity in clinical trials, including relevant references from FDA guidance.

1. Low Patient Enrollment and Retention Rates
   • Simplify the trial design to reduce the burden on patients. Engage patients early in protocol development to understand their needs. Provide clear, jargon-free communication and logistical support like travel reimbursements and flexible scheduling. The FDA’s guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations emphasizes involving patients early to ensure the trial is patient-friendly and relevant.
2. High Dropout Rates
   • Gather detailed feedback from patients to understand dropouts. Address issues by implementing flexible visit schedules and providing continuous support throughout the trial. The FDA’s Patient-Focused Drug Development: Collecting Comprehensive and Representative Input highlights the importance of collecting patient input to inform trial design and address needs.
3. Low Patient Engagement
   • Increase engagement through regular updates, interactive digital tools, and patient communities. Regular check-ins and personalized communication foster stronger connections. Engaging patients throughout the trial process, as suggested in various FDA guidances, helps maintain high levels of patient engagement.
4. Complex and Burdensome Protocols
   • Simplify protocols and eliminate unnecessary complexities based on patient feedback. Implement user-friendly technologies and provide comprehensive training. The FDA encourages simplified and patient-friendly trial designs to enhance participation and compliance.
5. Lack of Diversity in Patient Population
   • Adopt inclusive recruitment strategies and collaborate with community organizations. Use diverse media channels for broader outreach and provide culturally sensitive materials. The FDA’s “Enhancing the Diversity of Clinical Trial Populations” (2020) provides strategies to improve diversity in clinical trials.
6. Insufficient Communication with Patients
   • Enhance communication by providing regular updates, ensuring transparency, and offering multiple contact methods. Use plain language and culturally sensitive materials. The FDA emphasizes clear and continuous communication to keep patients well-informed and engaged.
7. Poor Patient Feedback and Satisfaction Scores
   • Regularly collect and analyze patient feedback. Address concerns promptly and adjust procedures accordingly. Patient satisfaction surveys can identify improvement areas, and collecting and acting on patient feedback is key in patient-focused drug development, as highlighted by the FDA.
8. Limited Use of Digital Tools and Remote Monitoring
   • Incorporate digital health tools to reduce physical visits and enhance convenience. Provide necessary support and training for patients to use these technologies. The FDA supports the use of digital health technologies to improve trial efficiency and patient experience.
9. Inadequate Support for Patient Advocacy
   • Engage patient advocacy groups from the outset to gain insights and support. Their input can help shape a trial that meets patient needs and priorities. The FDA recognizes the importance of involving patient advocacy groups to enhance recruitment and retention.
10. Rigid Trial Designs
    • Adopt adaptive trial designs that allow modifications based on interim results and patient feedback. Being responsive to patient needs can improve trial success. The FDA supports adaptive trial designs to enhance patient experience and trial outcomes.

Conclusion

A patient-centric approach in clinical trials is not just a trend but a necessity for the success and ethical conduct of research. By monitoring these key indicators and implementing the suggested corrections, you can ensure that your clinical trial is truly designed with the patient at the center. This not only benefits the patients but also enhances the quality and efficiency of the clinical trial process. By addressing these KPIs and fostering a patient-centric environment, your clinical trial can achieve better outcomes and contribute to the advancement of medical research in a more inclusive and effective manner. For more detailed guidance, refer to the FDA’s documents on patient-focused drug development and clinical trial design.

Cloudbyz EDC is a user-friendly, cloud-based solution that is designed to enable patient centricity of your trials and store and manage clinical data effectively throughout a clinical trial’s life cycle. Our innovative solution enables clinical research teams to efficiently collect, analyze, and manage clinical data of different complexity and size. Cloudbyz EDC is a scalable solution and meets all the essential regulatory compliance requirements such as FDA- 21 CFR Part 11, GCP, GAMP5, HIPAA, and EU- GDPR.

To know more about the Cloudbyz Unified eClinical Platform contact info@cloudbyz.com