Centralizing Study Communication Can Significantly Improve Outcomes
Posted by: Tina Schlecht, PharmD, MBA
Some years back, at the beginning of a Phase 3 trial, it was discovered that the study medication instructions had been printed incorrectly in one of the study aids. The instructions stated that patients should take the medication before breakfast and before dinner. In most regions of the U.S., dinner is a meal taken in the evening. However, in some parts of the country, it is a meal taken at noon. The error was discovered during visits with the first enrolled patients. The sponsor was immediately notified and promptly sent correction notices.
Two questions are key here. Who discovered the mistake and how? And what measures were taken thereafter to remedy the communication issues and safeguard the well-being of patients?
The issue was first identified by a study pharmacist during the course of a scheduled patient call to discuss the patient’s understanding of the study medication. The pharmacist, as the medication administration expert, then began asking other patients for specific dosing times and the potential scope of the issue was further revealed.
Following discovery of the mistake, it was the study pharmacists who thereafter played a key role in further educating study sites and patients about the proper time of administration and catching potential errors. This expert guidance helped to improve patient medication compliance in following the correct directions and patient retention in the study. Having expert pharmacists at the center of activity also helped improve communication amongst all clinical trial stakeholders.
Current Communication Model
Traditional information flow in clinical trials follows a linear design, from the sponsor to the CRO to the investigator and, finally, to the patients. This model is problematic because communication flows back and forth along only one path. Linear communication requires information to flow through multiple intermediaries, slowing the delivery of important information, and making miscommunications nearly impossible to detect and correct in a timely manner. Consider that a large study with 90 investigators means information will be communicated in 90 different ways to patients, without a method to confirm the understanding of the information by each patient.
Communication Model for Today’s Clinical Trials
The way to solve this problem is to centralize the communications process, with pharmacists at the center. In this approach, pharmacists are responsible for being in active contact with all patients, all sites, site monitors, and the sponsor and relaying important study medication information between all groups in a concise manner.
Through their interactions with patients, pharmacists are alerted to important issues as they arise, including patient misunderstandings about proper dosing, compromised study medication due to improper storage conditions, or new concomitant medications. Prompt communication of these issues by pharmacists to sites, sponsors, and site monitors allows them to be addressed in real time, before they can become a problem, or before the study ends, when details have been lost or forgotten. The addition of pharmacists also allows for communication to flow swiftly in the other direction, with pharmacists relaying information about urgent matters immediately from the sponsor or CRO to all sites and patients, as was done in the Phase 3 study cited above. Pharmacists can also address concerns about possible fraud by verifying all patient enrollment and alerting the sponsor to any abnormal activity.
In a 2013 report on the ISPE Project Concerning Patient Experiences with Clinical Trial Materials, patients broadly agreed that interaction with pharmacists and study staff to review the study medication instructions improved their participation in the trial. More than 75% of patients surveyed indicated they found it very helpful to receive verbal instructions for use of the study medication and to have the opportunity to ask questions. Furthermore, patients thought of the study as high quality with professional staff when someone took time to engage with them about the medication instructions and check on their compliance. (1)
Good Communication Is Always The Key
No matter what the industry, no matter what the project, clear communication and procedures are essential to running a smooth initiative and achieving credible outcomes. Clinical studies are no different. In fact, clear communication may even be more important here as it could mean all the difference to the success of the trial and to the advancement of the development program.