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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.

  • Medical Compliance in Clinical Trials

Why Do Patients Struggle to Stay on Track?

  • Complicated and confusing consent forms that are challenging for the average person to understand.
  • 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 protocols.

  • effectivness of Clinical Trials

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.