3 Challenges Clinical Trial Managers Face

 
 

Our research suggests many patients simply do not follow the correct dosing regimen in a clinical trial. This article explores the medication adherence and compliance challenges study teams encounter when conducting a clinical trial.

1. Avoiding Early Compound Withdrawal

When patients fail to comply with their treatment regimen, the impact of poor or unbalanced dosing across the various arms of a clinical trial can have a significant effect on your claims and final study submission.  Could patient noncompliance be one of the reasons why some compounds are withdrawn from market after extensive research?

2. Obtaining Quality Endpoint Data

Sponsors invest billions of dollars in creating compounds to improve patient wellbeing and generate profits; these profits are reinvested to keep the innovation cycle moving forward. Researchers work passionately to solve complex medical challenges. But when patients do not dose correctly, study findings are misleading thus negating the time, money, and effort invested in the compound and the trial.

To illustrate, let’s look at typical groups in an early phase study. Let’s imagine the following medication adherence scenario, where patients should dose daily with food:

Placebo

In this group, patients are not feeling any improvement, so some chose to stop dosing while others just forgot to dose altogether.

Dose Level 1

Some patients are feeling some benefit.  A number of patients dose with food as instructed at the correct time, but others dose with water if they remember to dose at all.

Dose Level 2

Some patients reported side effects.  Those feeling the effects stopped dosing while others continued.  It is unknown if they dosed with food or water.

Competitive Comparator

This group mostly dosed as instructed.


Questions and concerns to consider about this data:

  • How would a statistician interpret this variable data?
  • What margin of error do they introduce to allow for medication non-adherence?
  • What conclusions would they draw?
  • What would your submission claim state given the mixed medication adherence and compliance?
  • What implied pressure would there be on the study team after spending money and time to gain mixed data?

Even this simple case study demonstrates how differing levels of medication adherence across a typical clinical trial can have a negative impact on the quality of study endpoint data.


3. Finding the Right Solution for Your Patient Compliance Needs

Sponsors and their study teams recognize that medication compliance and adherence is an area that needs improvement, and they are looking to specialists in patient drug compliance for help.

Clinical trial leaders face daily challenges when conducting clinical trials.  From study investment pressures and timescales to choosing the right vendors, they have to work intelligently and efficiently.  Study teams need a solution that is quick and easy to deploy and custom built to meet their study’s requirements. They also expect a knowledgeable support team to guide them through set up and beyond.

Cenduit Patient Reminders™ is an elegant, easy-to-use platform that sends personalized, timely reminders to patients via SMS text, email, voice, and calendar alerts. These reminders are designed to keep the patient engaged in the trial and ensure they attend their site visits on time and in the correct state.  In addition, system set up takes days rather than weeks, and it can be integrated seamlessly with the study team’s IVR/IWR system. 

Selecting the right partner to assist you with your patient compliance challenges is not an easy task, and with so many solutions out there, how do you know if Patient Reminders™ is the right fit for your trial?  You can request a demo of the system here or download our latest white paper.