Patient compliance is even more important when we talk about clinical trials. There are lots of statistics showing the financial losses from prescription drugs that were never taken. However, when we talk about clinical trials compliance is not just limited to drug administration. It also includes attending visits as per schedule, having all required procedures, reporting adverse events and concomitant medications, etc. Still lots of patients miss their visits or procedures, do not take their medications, and are not fully aware why this is important. 

How to explain compliance from clinical trials point of view to your patients?

Try to explain to your patients the importance of compliance with quick questions and answers.

1. Why it is important to take the medications? – First of all, in majority of the cases the medication is experimental and all effects and optimal doses are unknown. When the patient misses a dose this could result in taking sub-optimal dose that could lead to worsening of the condition. 

2. What if you cannot attend an appointment? – It is important patient to notify clinical trials team as soon as possible if not able to attend. Usually there is a treatment window for drug administration and procedures. The idea is to monitor drug safety and assure that patient takes the optimal drug dose. It is beneficial for the patient to attend all appointments to allow physicians to assess how the drug works.

3. What if you cannot attend an appointment because you are not feeling well? – Patients should understand that it is important to report all adverse events because they could be drug related. Depends on the clinical trial, some allow drug interruptions (and even recommend them) until patient recovers. 

4. Why do you call patients after they have completed their treatment? – Because the patient was part of clinical trial with experimental drug, the protocol requires patients to be contacted for follow up to monitor long-term effects of the drug. The purpose of these calls is to check if the patient is feeling well and if there are any complications.

5. Why some medications are prohibited? – Some medications could interact with the clinical trial medication and could lead to some complications. It is important to know what not to take in combination with the experimental drug because it could have serous safety consequences. 

If your patients understand that all these precautions are for their own safety, they will be more likely to attend their appointments and take the medications.

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 1 June 2014