More than half of American patients have no knowledge of clinical research. This was found in a study from 2013. It demonstrates a positive development, since a similar study from 2000 showed that less than one fifth of patients had knowledge of clinical research back then.
It is obvious that patients, who are not familiar with clinical research, are not given the opportunity to participate in clinical trials. Out of all the US patients in the study, who were offered to participate in clinical research, only a half of them took advantage of the opportunity.
For a significant portion of those patients, who were informed of clinical research, it was concluded that it did not make sense for them to participate in certain trials because these trials were not relevant for their diseases.
Certain groups participate less in clinical research, but there may be a reason
In a study of 300 clinical research trials focused on cardiovascular disease in the US, only one quarter of the participants were women. This is despite the fact that cardiovascular disease is the leading cause of death among women in the US, and that more women suffer from the disease than men do. However, the fact that men mostly participate in clinical trials may be due to the fact that women have more hormones than men do, which means that clinical trials can be more difficult to conduct with women. Because of this, women do not always meet the inclusion criteria for the trials or are not selected by the researchers, who would need to do more work with female participants compared to if only men were included in the trials.
The same trend can be seen among African-American patients in the US, which is the minority group that suffers the most from cancer. Despite this, African-Americans only account for about one percent of the patients involved in clinical trials, while they account for about 12 percent of the total population in the US. In continuation of the aforementioned reasoning, this trend may also have to do with the fact that researchers have found e.g. that African American patients react differently to some forms of medicine than Caucasian patients do.
A study from the US shows that people with a lower income received the offer to participate in a clinical research trials seven percent less than people with a higher income did. The low-income group therefore never got the opportunity to decide for themselves in some cases.
In the US, there are other factors that play a part compared to in Europe. This is due to the fact that there is self-payment for treatments to a greater extent in the US if you have not taken out insurance.
In the study, it was investigated which considerations led lower-income patients to be less inclined to participate. Among other things, the patients’ responses included the belief that their treatment would be more expensive and that they felt less risk-taking.
The researcher behind the study, Moon Chen, suggests that here too, the lack of information on clinical research is what makes the difference. He does not believe that the public sector does enough to inform about what opportunities exist and at the same time, he is calling for the initiation of more efficient recruitment work.
The four phases of clinical research
Before a new type of treatment is approved for human trials, thorough considerations are made and it has also been pre-determined whether potential results outweigh potential risks.
Patients who have little or no knowledge of clinical research may not know that clinical research, tested on patients, in most cases already has been tested on animals (this occurs prior to human trials and is referred to as pre-clinical research) and a minor group of healthy people in order to safeguard against potential risks.
Clinical research is divided into four phases, which proceed as follows:
The experimental treatment is tested for the first time on small groups of healthy participants (20-80 participants) to evaluate safety, establish a safe dose of treatment and identify potential side effects.
The treatment is tested on a larger group of participants with the specific disease (100-300 participants) to see if the treatment has an effect and to evaluate the safety of the treatment.
The treatment is tested on a large group of people (1000-3000) to confirm the effect of the treatment, monitor side effects, compare the new type of treatment with treatments already employed and collect information in order to ensure that the new treatment is used safely.
This phase is also known as the post-marketing studies, in which it is investigated how safe the medicine or treatment is after the product has entered the market. This is carried out once the experimental treatment has been approved. This phase provides additional information on the treatment, risks, benefits and very rareside effects.