Being involved as research subject in clinical trials
Being a research subject in a clinical trial is the most common way that members of patient organisations will have been involved in clinical research. In this survey we made use of the following definition for a clinical trial:
A research study with human subjects. This study is often used for the evaluation of a new treatment. Every study has been designed to answer certain scientific questions and to find new ways to be able to treat patients. Clinical trials help determine whether a promising new treatment is safe and effective, by gathering information on the risks and efficacy of the treatment. Furthermore; to be able to take part in a clinical trial participants have to sign an informed consent form.
Patient Partner acknowledges that being a research subject in a clinical trial is of upmost importance for the development of future and known therapies. However, we believe that patient organisations have more to offer the clinical research process than being a studied subject. Patients who live on a daily basis with their disease are said to have experiential knowledge: the knowledge that is based on the day to day life of living with an illness or medical condition.
Patient organisations are the place where this knowledge is combined, a knowledge base which has potential to give rise to better insights and therapies that are more representative of the patient’s needs.
To identify how many patient organisation have members that have experienced being involved in a trial as a research subject and in what way we asked:
Are/Have you or your patient organisation (been) involved as a research subject in a clinical trial?
24% of all respondents show to have experience in being involved on a level of being a research subject.
In more detail; 28% of the respondents stated to have participated in a clinical trial themselves. Another 35% of all respondents said that members within their organisation had participated in a clinical trial. Patient organisations stated to be involved in a range of different clinical trials, from the comparison of different therapies and or drugs, primarily in phase 2 and 3 trials to the involvement in trials that were looking at the quality of life issues surrounding a specific condition .20% of the respondents had personally contributed biological material to a clinical trial as well as 20% of the respondents referring that their members had. 17% of the respondents had personally contributed to a biobank or database that was to be used in a clinical trial vs. 20% of the members of their patient organisations. In the detailed description there were no references to specific biobanks. References were made on what the material was donated e.g. investigating the genetics of a specific condition. There was one entry describing the involvement in a patient registry. More on Biobanking and patient registries can be found in the section on biobanking.
18% of the respondents said that they were involved in other ways as a research subject. The most common other way of being involved as a research subject was in helping to recruit volunteers for clinical trials amongst the members of patient organisations primarily by placing a call or an advertisement (as a patient organisation, not the researcher or pharmaceutical company) in the patients journal/magazine. As in the description of the main question, patient organisations gave further notice to their involvement in trials on quality of life issues.
Regional differences in being involved as a research subject in clinical trials
The surveys shows that respondents from Central Eastern Europe tend to be less frequently involved as a research subject in clinical trials in comparison with the responding patient organisations in the North-western and Southern European Region.
Please click below for the overview graph of the involvement per region in clinical trials on all levels.
Overall regions compared
North-Western Europe
Central and Eastern Europe
Southern Europe
Disease-group specific differences in being involved as a research subject in clinical trials
According to the survey, patient organisations that represent the rare diseases are more frequently involved as a research subject in a clinical trial, as a contributor of DNA and biological material and subsequently as a contributor to a biobank and/or medical database as compared to patient organisations representing common diseases.
Overall comparing the"common" with the "rare" condition patientorganisations
Patient organisations representing the "common" conditions
Patient organisations representing the "rare" conditions