- A Biopharmaceutical Company Sponsoring a Phase III Clinical Trial in the U.S.
The sponsor initiated a critical Phase III trial at a tenuous time in its history. The sponsor knew it had a viable product, but worried that patient compliance and retention would prove to be challenging obstacles because the trial would be placebo-controlled, include a medication administration device with complicated instructions, and would enroll patients for 30 weeks. In addition, the sponsor had limited funding, making overall cost control of the trial a necessity.
Concerned about patient compliance with a complicated dosing regimen and their ability to meet the clinical trial objectives and timelines, the sponsor needed a method to ensure medication compliance and patient retention in the trial. Services provided by Clinical Trials Research Pharmacists (CTRP®) were selected to address the sponsor’s needs. Following a protocol review, CTRPs worked with the sponsor to identify critical trial junctures where special assistance from pharmacists would benefit patients and have the greatest effect. CTRPs then established a set schedule for calls based around those junctures, and outlined specific questions and topics to discuss with each patient. CTRPs also developed and created an instructional training video to assist patients with proper medication administration.
Results: Over a sixteen-month period, CTRPs made 2,550 patient contacts and improved patient compliance with the trial medication. CTRPs provided patient counseling and corrected patient errors related to:
- Medication administration – CTRPs made corrections relating to improper medication administration for 50% of patients
- Medication use – CTRPs corrected errors related to the proper dose, timing of doses, or missed doses for 30% of patients
- Concomitant medications – CTRPs identified 22% of patients as improperly starting, using, or stopping concomitant medications
- Other – CTRPs discovered that 24% of patients either stored their medication, used the IVRS, or used ancillary supplies incorrectly
- In total, CTRPs identified and corrected at least one patient error for 92% of all patients in the trial
In addition, the sponsor exceeded its projections of patient retention:
- Estimated number of patients to be randomized: 400
- Actual number of patients randomized: 371
- Estimated number of patients to withdraw: 25
- Actual number of patients to withdraw: 9
- Improvement in withdrawal rate: 64%
By exceeding its expectations for patient retention, the sponsor was able complete the study enrolling only 371 patients instead of the expected 400, resulting in significant savings to the timeline and budget.
By including CTRP services in this trial, the sponsor met and surpassed its patient compliance and patient retention goals. The real-time information CTRPs provided about patients also led to improved documentation and better quality data. CTRPs successfully engaged the patients, making the trial into a more positive experience, and causing many of them to continue on to the sponsor’s next trial. Most notably, the involvement of CTRPs helped the trial drug go on to receive market approval by the FDA.
- A Company Sponsoring a Small OTC Trial in the U.S.
After completing initial clinical trials to test the safety of its product, the sponsor began a study to evaluate new over-the-counter (OTC) product formulations. The sponsor needed the ability to initiate the study quickly and to be able to easily pivot and make strategic changes rapidly. The ability to interact with patients in an organized and timely manner was essential. The sponsor also identified retention as an important aspect to keep the study timeline on track.
Solution: Center Point worked with the sponsor to identify the most efficient process to initiate the study within a four-week timeline, established a set contact schedule for our Clinical Trials Research Pharmacist (CTRP®) calls, and outlined specific questions and topics to discuss with each patient. Center Point also collaborated on the development of additional study materials for patients, and assisted with the development of a database repository for data collected during each pharmacist call.
Forty-five patients participated in the six-week study. In total, Center Point completed 193 contacts with patients to discuss compliance, collect study data, and record patient feedback. The comments from patients provided valuable insight into their experiences, and Center Point’s position as a central repository of that feedback enabled the sponsor to receive it and react in real time. Two weeks into the study, the availability of that data resulted in the sponsor making a significant change to the protocol, and the patient-centered nature of Center Point’s CTRP service meant our pharmacists were able to begin contacting patients the same day to relay the new instructions.
In addition, our CTRP services helped the sponsor to meet its projections of patient retention:
- Number of patients enrolled: 45
- Number of patients who completed: 41 (91%)
- Number of patients who provided evaluable data: 44 (98%)
- Retention rate: 91%
By including Center Point pharmacist services in this study, the sponsor executed and completed the study on time, setting course for its follow-up study. Retention in the study exceeded 90 percent, and more than 80 percent of patients who completed the study went on to participate in the follow-up study.
- A Biopharmaceutical Company Sponsoring a Phase II Clinical Trial in the U.S.
The trial required patients to administer the study medication at home by self-injection with a pen-type device. A majority of patients were injection-naïve and required on-going training in use of the device. In addition, the trial also required patients to conduct blood glucose tests at home, multiple times per day. The sponsor recognized the need for supplemental medication training, as well as timely reminders for and instruction in blood glucose testing.
Solution: The sponsor added Clinical Trials Research Pharmacist (CTRP®) services to the protocol. The services included medication counseling and instruction in blood glucose testing for each randomized patient. CTRPs called each patient on the specific trial days which assistance from pharmacists would most benefit patients. Pharmacists also remained on-call 24/7 for patients and sites to address questions or concerns.
During the study, CTRPs made 441 patient contacts and improved patient compliance with the study medication and protocol requirements. CTRPs provided patient counseling and corrected patient errors related to:
- Medication administration and concomitant medications during 200 (45%) patient contacts
- Blood glucose testing and proper use of the glucometer during 45 (12%) patient contacts
Specific examples of patient interventions include:
- Patients not taking the study medication the correct number of times per day
- Patients having trouble with the injection device or injecting multiple times
- Patients being unclear about blood glucose testing instructions and use of the glucometer
Overall, CTRPs identified and corrected at least one patient error during 75% of all patient contacts.
Involvement of CTRPs improved study medication compliance and enhanced the overall care each patient received in this study. Pharmacists, chosen because of their medication expertise, answered patient questions, identified potential problems, and reinforced correct use of the study medication. In every instance, a pharmacist contacted and notified the site of the issue.
Conclusion: With the addition of the CTRP service, the patients became more well informed and committed to the trial, the sites appreciated the addition of a pharmacist to the team, and the sponsor received improved documentation and higher quality data, which helped to meet the study objectives.