Physicians and nurses are used to take informed consent from their patients routinely in their practice, however consent process for clinical trials in much more complicated. While in standard practice the consent cover specific procedure or tests, in clinical trials the informed consent covers all procedures and tests during patient`s participation. 

It will be relatively easy to print a diagram of the procedure and explain to your patients why this is necessary for them, but try to explain them almost 30 pages clinical trials informed consent, including months of treatment and tests, possible adverse events (some of them quite scary), prohibited medications and procedures, etc. Not every physician or nurse will feel confident enough to do this and in reality lots of clinical trials teams struggle with this task.

Sponsors are not helping with the consent forms as well. The tendency is clinical trials informed consent forms to grow bigger and bigger, with lots of details, as companies are trying to provide as much as possible information to the patients. This means that patients will rely even more on their physician or nurse to explain them what is required.

Ability to take informed consent from patients directly affects the recruitment for the study. But this is only one side of the problem, the other major issue is that patients who will benefit from the new treatment options are not included in the clinical trial because they fail to understand the positive effects.

There are numerous documents and regulations providing details on how to consent patients but it is always different in practice.

So what can be done to assure your patients understand the benefit of the clinical trial?

  • Physician or nurse who will take informed consent needs to be properly prepared to do so. They need to be familiar with the product, its adverse events, prohibited medications and administration requirements. Also they have to understand the design of the clinical trial – what is required for each visit. The logic is simple – if you do not understand the objectives behind the clinical trial, you will not be able to explain them clearly to your patients.
  • Physician or nurse has to be prepared to answer questions regarding already approved treatment options and clearly explain the alternatives to the patients, in case they are not willing to participate. Using diagrams or brochures that could be given to the patients will be very beneficial.
  • Make sure you present to your patients not only benefits but also potential risks of the clinical trials. Not covering the risks will look like you are holding back information.
  • Explain to your patients that they may not be eligible for the clinical trial and that additional tests are required. Lots of patients feel frustrated because they did not realize that signing informed consent is not enough to participate in clinical trial and that there are criteria that have to be met.
  • Encourage your patients to discuss the consent with there relatives if they want.
  • Ask questions at the end to make sure your patients understand what is required from them.
  • Some clinical trials are ongoing for years. Patients have to be familiar with the commitment that they will make.
  • Inform your patients that if new safety information is available they will be informed and probably required to sign a new informed consent form. 
  • Consider inviting your patient to your office or another location where you can have proper discussion. 
  • Lots of patients do not understand the objectives of clinical trials. Often they refuse to participate because they “don`t want to be guinea pigs”. Explain the idea of the clinical trials before offering them to participate. 
  • Last but not least – never rush your patients into making a decision. Yes, clinical trials teams are busy and there is a window period to enroll the patient, but putting pressure on patients to make a decision is not ethical solution.

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 14 Mar 2014