Every study patient decides if, how and when they will take the study drug.
Our patient programs meet the needs of study patients and increase patient adherence because:
- We put ourselves “in the patient’s shoes”.
- We have clinical trial expertise.
- We know how to increase adherence and motivate patients to manage the study drug safely and wisely.
- We know how to build patient trust in the study team, improve communication and obtain honest patient feedback.
Ask Yourself, “What if I were the Study Patient?”
Ensure patient adherence strategy is acceptable to patients
The most logical approach is to integrate patient compliance strategies during Phase III – and even Phase II – for the following reasons:
- Develop the patient adherence strategy for the clinical trial. This strategy can later be applied to the product launch.
- Develop the patient recruitment materialsbased on the patient adherence strategy so that you recruit patients who understand the importance of their participation in clinical trials and how it can help them personally.
- Develop patient information materials for clinical trial that are motivational and understandable to patients. Motivate your study patients to take the study medication more accurately so that
- Increase patient adherence in your clinical trial so that your study results will reflect a more accurate side effect profile and more accurate dose. It is critical that your FDA-approved dose is accurate and not toxic. The patient adherence rate in your clinical trial must be HIGHER than that of patients in the general population. Avoid unexpected post-marketing toxicities and lawsuits when patients in the general population are more adherent than study patients.
- The patient adherence and patient education strategy can be tested during Phase III. During Phase III, it will be possible to determine the effectiveness of your patient education program on patient adherence. Any problems can be identified and corrected so that you are well-prepared to overcome the patient adherence barriers at launch.
- You will have the advantage of being able to submit results of patient comprehension and patient adherence with your NDA. Phase III can also serve as the testing ground for your patient education program. By developing Patient Package Inserts (PPIs) and how-to-use instructions for administration devices during Phase III, you will have the assurance of knowing patients can understand your proposed Patient Labeling. You will also be taking a step towards meeting FDA concerns that patient labeling be understandable.
- You will be able to submit a well-tested Patient Package Insert with the NDA and be far ahead of those companies that wait until 6 months prior to launch and depend on focus group testing.
- You will be saving money by testing the patient information materials during Phase III so that you only have to “fine-tune” them after the clinical trial. You will have the assurance knowing your Patient Labeling and compliance programs have been based on clinical trial experience prior to the FDA submission.
The FDA is concerned that patient education materials in clinical trials must be understandable. Many patients in clinical trials are not taking their medications correctly and this seriously impacts the results of clinical trials.
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.