Medical Adherence and Compliance During Clinical Trials
Why are Medical Adherence and Compliance So Important?
Patient adherence and clinical research is a topic seeing much action as of late. It is
becoming a topic of increasing concern and the medical industry is seeking solutions to
the ever-growing issue. Patient compliance during clinical trials can include the
patient properly adhering to study procedures, study visits, taking medications, event
reporting, and updating, and much more. These issues are so critical because not only
can they affect the overall cost of the study and increase the budget of the study
drastically, it can also severely skew the outcomes of the study.
According to Moe Alsumidaie , “a 20%-30% decrease in medication adherence
may result in increasing the patient sample size by 50% in order to maintain sufficient
statistical power, and a 40% non-adherence rate would require a 200% increase in the
sample size in order to maintain significant statistical power, resulting in increased
clinical trial costs, and medical product approval delays. Additionally, up to 30% of
clinical trial participants may be throwing out investigational product before study
visits, and are untruthful about medication compliance when communicating to clinicians,
which can impact regulatory dosing recommendations upon medical product approval.”
Patient adherence and compliance is essential to the overall accuracy and budget of the
clinical trial. Appropriate solutions to non-adherence must be made and followed.
Why Do Patients Struggle to Stay on Track?
- Complicated and confusing consent forms that are challenging for the average person
- Consent forms that are far too long – in excess of 20+ pages, make it hard to all
people to read all of the information and retain that information.
- Communication challenges and issues between patients and doctors – patients are not
completely honest with the doctor about their experience in fear they will
disappoint the doctor/physician.
- People tend to live busy lives. People fear they will be dropped from the clinical
trial if they don’t stick to the protocols perfectly.
How Can Technology Fix These Issues?
There is quite a few ways technology can help reduce these issue and increase patient
compliance and medication adherence. Text messages have been found helpful for patient
compliance in clinical trials and research. For instance, text messages can be sent to
patients to help remind them to take their daily medication or reminders about proper
post-surgery care. Not only did it help patients comply with their medical regimens, but it
also reduces the amount of adverse and dangerous health effects of non-compliance.
Furthermore, simplifying and digitalizing complicated and lengthy consent forms will
also have huge benefits. Patients have a hard time fully understanding these forms and
also don’t have the time or patience to read them from top to bottom. Therefore, it is
essential to uncomplicate these forms and make them easier to understand and retain.
Additionally, adding visuals like charts, pictures, and visual roadmaps would also be
helpful for patients looking to understand their clinical trail information and
Digitizing these consent forms can also allow for informational videos to be placed
within the forms as well, which can make rules even easier to understand. Videos allow
little room for personal interpretation and allow patients to physically see what they
need to do.