There is a growing number of medical device clinical trials globally. While they have lots of similarities in terms of study design and documentations to drug clinical trials, medical device clinical trials also have some unique challenges. In this review we will discuss the challenges in preparing patient information sheet and informed consent form for medical device clinical trials. 

But let’s start with the biggest challenge for medical device studies when it comes to patient facing documents like patient information sheet: Very often medical devices are complex and require not just medical but also technical knowledge to be understood. The people who design patient related documents have that knowledge already, but this is not the case with the patients. 

  1. Provide information of the usage of the medical device: While some medical devices are new and not been used in patients before, many medical devices are available on the market for different indications. Including this information in your patient information sheet will allow patients to be better informed and make it easier for them to make a decision if they want to participate.
  2. Show how the device looks like: While with drug clinical trials showing how the actual drug looks like has never been exciting this is completely different when it comes to medical devices. Showing a photo or schema of the device will help people understand better what you are describing to them. 
  3. Provide simple explanation how the device works: Many medical device companies have excellent patient-friendly videos explaining how their device works. Links to these videos could be placed in the patient information sheet and patients could be encouraged to watch the video which will provide them more visual explanation but also prepare them what to expect. Don’t assume that patients will look for that information. In many cases patients are under a lot of stress having to cope with their medical condition and searching for a video may not even occur to them.
  4. Avoid medical and technical terms where possible: Try to use simple words and explain the medical device in a why you will explain it to a child. You know where vena cava is but for many patients this means nothing. 
  5. Clearly explain what patients will have to do: It is important to explain the design of the study and what visits patients will have to attend but also what will be happening at each visit. Are there any special requirements like patients having to wear face mask, or blind fold, or not eat before a test, or the procedure has been recorded, or anything else? Make sure this is explained.
  6. Make sure patients are aware of any contradictions: For example, if the medical device is a metal implant this could affect further treatment for the patients as they may not be able to have MRI scan if necessary for diagnostic purposes. This must be explained in the patient information sheet because it is related to patients’ safety.
  7. Clearly explain expected adverse events: Many medical devices have a list of adverse events based on literature research or small previous study. Interestingly, in many cases the adverse events listed as possibly related to the medical device in the patient information sheet are actually not related to the device at all but rather related to patients’ medical condition and its complications, the medical procedure, etc. Separating the two could be a challenge especially if the information is based on literature review but in such cases, this has to be clarified. It is important to include information what adverse events are reported related to the medical device only as assessed by physicians and manufacturer. While not listing all safety information is misleading the same applies when overstating the safety concerns.  
  8. Explain what is done routinely to patients: In many cases some of the procedures related to the medical device are done routinely to this patient population. This means that patients may already have some experience and knowledge of these procedures. Patients should be able to understand what to expect and if it will be done to them the same way as it is done routinely for their medical condition. 
  9. Consider the amount of time patients need to decide about their participation: According to the Good Clinical Practice patients should be allowed at least 24 hours to decide if they want to participate in the clinical trial. However, in case of emergency clinical trials patients may not have so much time to decide and this needs to be explained in the patient information sheet. Such an example could be a surgical equipment which is used in emergency medicine. 
  10. Patients’ involvement: The best way to see if your patient information sheet is well written is to ask actual patients to review it and provide you feedback. Patient involvement is gaining popularity globally and now is often requested by competent authorities reviewing clinical trials. 
  11. Keep it simple and relevant: You will probably think it is easier said than done but when you have a complex medical device keeping the information simple and relevant will help patients understand the device and its purpose. 

While this is not a comprehensive list of recommendations on how to prepare patient information sheet for medical device clinical trials it captures the main points which I have identified from my work with medical devices. 

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. 

Published on 10 Feb 2023