Patient & Protocol Compliance In Clinical Trials

Source: Cenduit LLC

When a patient does not comply with the treatment regimen, the integrity of the clinical trial is at stake and patient safety is at risk.  

Top Reasons for Poor Medication Compliance

  • Forgetfulness (patient was not reminded to dose)
  • Disbelief that the medication is helping
  • ear of potential side effects
  • Experiencing actual side effects
  • Belief that medication may negatively impact performance of daily activities
  • Confusion over medication instructions
  • Overwhelmed by quantity of medications prescribed
  • Difficulty opening medication container or swallowing medication

Patients are people and lead busy lives; noncompliance is often not intentional. Patients feel valued and are more engaged with the clinical trial when they receive thoughtful, personalized reminders from investigator site staff. This leads to improved overall compliance.

Take a proactive approach to protocol compliance.
The Food and Drug Administration (FDA) is placing increasing pressure on sponsors to ease the medication compliance burden on patients. If clinical study teams implement medication adherence plans prior to study go live, this will prevent study delays, decrease the burden on investigator sites and patients, and ultimately increase the reliability of study endpoint data.

Patient Reminders™ are personalized, automated SMS, email, and voice messages sent to the patient or caregiver. Reminders help stakeholders arrive on time and prepared for their clinic visit. The result is higher quality investigational procedures completed within the time window demanded by the protocol and reduced instances of patient early withdrawal and lost to follow-up.


  • Improved patient and protocol compliance 
  • Improved patient attendance at the clinic
  • Increased reliability of the endpoint data
  • Reduced study costs and risks