Clinical Trial Patient Education, Adherence, Compliance Experts
“Voice of the Patient” in Clinical Trials
In every clinical trial, the role of the patient is critical. There is a false belief that patients are going to follow the prescription instructions exactly as prescribed.
What happens when study patients “decide” not to take the prescribed study dose? The design of a clinical trial can be flawless, BUT if the patient “decides” not to take study drug correctly, the results of the trial will be significantly flawed.
So much so that the study dose approved by the FDA could be too high and toxic for patients post-launch who are more adherent.
- If the patient does not understand the study medication instructions and any required record keeping, there is a high probability that the patient will make medication errors and not take the study drug correctly.
- Patient adherence in the clinical trial should be at the 95% level so that it is always higher than that of very adherent patients post-launch.
Protect your company from unnecessary patient deaths and lawsuits by ensuring that study patients are at least 95% adherent.
Unfortunately, unexpected post-marketing toxicities that are occurring many years after FDA approval may not be due to the drug at all – – but due to poor patient education & undetected poor patient adherence in the clinical trial.
If the patient does not manage study drug correctly nor provide honest feedback, it does not matter:
– how flawless the study design is
– how well patient adherence is monitored
– how strong the data analytics are
We are measuring suboptimal adherence
These errors can have a severe negative impact on the clinical trial results… including approval of a toxic dosage leading to unexpected post-marketing dilemmas if patients in the general population are more adherent than those in the clinical trials. Read More
Every clinical trial needs patient information that is based on a customized patient adherence strategy for the study drug. Consumer Health Information Corporation guarantees excellence in the development of:
- Patient Adherence Strategy for the Clinical Trial
- Patient Recruitment Based on Patient Adherence Strategy
- Patient Recruitment Materials that are motivational
- Informed Consent Forms that patients can understand
- “How to Take” Patient Instructions for the Study Drug
- Patient Education Materials for Study Patients & Caregivers
- Patient Diaries
- How to Use Reminder Tools and Study Packaging
- Tools to Improve Study Patient Feedback
- Content Partner & Adherence Strategy for Mobile Apps
- Compliance Packaging Consulting
- Training Programs (for Study Team & Patients)
- Finalize Patient Labeling for Submission to FDA as part of NDA
- Transition of Adherence Strategy to Product Launch
- Product Launch Starter Kits based on Phase III adherence strategy
PATIENT ADHERENCE AND PATIENT RETENTION WILL INCREASE WHEN WE MEET THE NEEDS OF PATIENTS IN CLINICAL TRIALS
Our Expertise in Clinical Trial Patient Education Is Unmatched
Let us put our over 30 years experience developing patient education programs for clinical trials to work for you!
Our team has expertise in:
- Developing the patient adherence strategy
- Developing all the patient materials for patient recrutiment and clinical trials
- Writing clinical information in an empathetic tone that patients can understand and relate to
- Developing “patient-friendly” informed consent documents
- Incorporating protocol into instructional study materials for clinical investigators
- Developing Patient Package Inserts (PPIs) that can be tested prior to the NDA submission and receive speedy FDA approval
- Notarized translations in 104 languages that can be used internationally
Our team of patient education experts have years of experience counseling patients and have worked with pharma medical, legal, regulatory and marketing teams and FDA for the past 20 years. All of our materials are designed with a focus on patient compliance with the goal that patients will be motivated to remain in the study and will take the study medications correctly.
“Make sure your study results are accurate.”
Click here for more information about Patient Package Inserts (PPI), Patient Compliance Programs, Disease Management Programs, Personal Progress Logs. For confidential consultation to discuss any of your clinical trial needs give us a call today at (703) 734-0650.