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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. While
patients in a clinical trial may be slightly more compliant
than the post-launch patients, there is still a great deal
of uncertainty over how often patients are missing or forgetting
doses. The study design and participation of health professionals
may be flawless... but if the patient does not understand
the medication instructions and any required record keeping,
there is a high probability that the patient will make medication
errors. These errors can have a severe negative impact on
the clinical trial results... including the dosage.
Make sure patients in your clinical
trials understand how to take the study drug. Consumer Health
Information Corporation has expertise in:
- Clinical Trial Informed Consent
Forms
- Clinical Trial "How to Take"
Patient Medication Instructions
- Clinical Trial Patient Diaries
- Clinical Trial Patient Videos
- Clinical Trial Patient Education
Materials
- Clinical Trial Study Packaging
- Clinical Trial Investigator Brochures
The most logical approach is to integrate
patient compliance strategies during Phase III - and even
Phase II - for the following reasons:
- By motivating patients to take the study medication more
accurately, your study results will reflect a more accurate
side effect profile and more accurate dose.
- A patient compliance and patient
education strategy can be tested during Phase III so that
this critical factor which can impact your ROI is thoroughly
investigated prior to launch. During Phase III, it will
be possible to determine the effectiveness of your patient
education program on patient compliance. Any problems can
be identified and corrected so that you are well-prepared
to overcome the patient compliance barriers at launch.
- You will have the advantage of
being able to submit results of patient comprehension and
patient compliance 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.
- 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.
We work with Pharma companies conducting clinical trials.
Our team has expertise in:
- developing all the patient materials for 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
- translations 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.
Click here for more information about Patient
Package Inserts (PPI), Patient
Compliance Programs, Disease
Management Programs, Personal Progress Logs.
Click here for more information about
Patient Package Inserts (PPIs).
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