There have been several occasions when people hear that I work on clinical trials and their reaction is “Oh, you are using people as guinea pigs!” I have shared my experience with some of the clinical trials teams and they also confirmed that that this is unfortunately still quite common reaction among general public. This is also one of the main reasons for participants to decline taking part in clinical trials. In this review we will discuss some tips on how to educate participants about clinical trial and help them make the best decision for themselves.

What makes people feel they are guinea pigs?

  1. The “Research” feeling – It is not surprising that the word “research” gives that unease feeling in some people that it is not known what will happen to them.  
  2. The “Placebo Myth” – Another common misconception is the “placebo” – majority of the people believe that all clinical trials include placebo and there is a 50% chance that they will not receive drug. It is true that some clinical trials use placebo but patients with medical condition are never left on placebo only and usually the placebo is given in combination of standard of care for the appropriate disease.
  3. The” drug is doing more good than harm” feeling – All potential participants are informed about possible adverse reactions but because it is regulatory requirement all possible adverse reactions to be listed in the informed consent that often represent an overwhelming list of scare reactions. On the other hand it is unlikely that people will read the medication brochure of a marketed drug (which also has an extensive list of adverse reactions) that leaves them with the impression that the clinical trials drugs are more dangerous.

How to educate potential participants about clinical trials?

I was explaining to a friend recently that all drugs on the market have been studied in clinical trials before obtaining marketing authorisation. He looked at me very surprised and said “You mean even aspirin?”

In order clinical trials teams to be able to educate their patients they need to understand themselves the preclinical data and what is known about the drug before reaching volunteers and patients.

Preclinical data is usually generated by using tissue cultures and animal models. The main purposes of preclinical data is to detect any harmful effects, to exclude any potentially harmful effects, to determine the dose and duration of the treatment and if possible to discover the mechanism of action. All this data allows clinicians and toxicologists to evaluate the risks of the new potential drug and to identify the unacceptable risks. 

For example, in vivo models require sufficient amount of animals to be included in order to obtain the required pharmacological, toxicological and dose-response data. Based on these results is calculated not only the dose for human clinical trials but also the dose escalation scheme. In conclusion during the different stages of drug development there are numerous preclinical drug safety studies, which are conducted in vivo or in vitro and provide the necessary safety information if the drug could be used in humans. All this data is generated to assure that clinical trials participants are not guinea pigs and their life and well-being is not put at risk.

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 3 Oct 2016