Methodology
The survey was based on 6 levels of patient involvement in clinical trials that were defined by the PatientPartner Task Force after making a translation from the Patient Participation ladder (Figure 1) in Scientific Research (Patiёnten participatie ladder in wetenschappelijk onderzoek) as described by Abma en Broerse, 2007.
The six levels of patient involvement of clinical trials and their sublevels are:
Being involved in a clinical trial as a Research Subject
As a research subject in a clinical trial
By contributing my DNA, cells or other biological material
As a contributor to a biobank or database for the use in a clinical trial
Being involved in a clinical trial as an Information Provider
Supplying disease specific information for the use in a clinical trial
Supplying information to patients on the possibilities of taking part in one or more clinical trial(s)
Supplying demographic and/or other characteristic information on the members that are represented by your patient organisation for the use in a clinical tria
Being involved in a clinical trial as an Advisor
Advising on informed consent forms , the procedure for explaining the consent form to patients, or the filling in of the consent form
Giving advice to or has been a (advisory) member of an ethics committee
Giving advice to or has been a (advisory) member of a national or European regulatory authority committee
Giving advice to or has been a (advisory) member of a clinical research program committee for the development of a clinical trial
Being involved in a clinical trial as a Reviewer
reviewer of a clinical trial research protocol
reviewer of a funding request for a clinical trial
reviewer of a scientific paper on a clinical trial
reviewer on patient information that is to be used in a clinical trial
Being involved in a clinical trial as a Co-Researcher
Interviewing patients
Leading a focus group or discussion session
Gathering information
Gathering research data
(Co)writing a scientific article on the research results of the clinical trial
Translating research results of a clinical trial into patient friendly information
Being involved in a clinical trial as the Driving Force
Lobbying for (the development) of clinical trials for the condition(s) that your patient organisation represents
Developing the clinical research protocol
Getting a research team together for a clinical trial
Raising funds for a particular clinical trial
(Co)financing a clinical trial
For the ladder of patient involvement in clinical trials and research please click here
In addition to the questions on the involvement in clinical trials on the levels described above, the respondents were asked to describe their involvement in two of the themes of the PatientPartner Project.
These Themes are:
Clinical trials with children (on all 6 levels of patient involvement)
Biobanking, medical databanks and patient registries (several sublevels were identified, see below)
- As a contributor to a medical databank or biobank with DNA, cells, other biological material, or data
- Involved in setting up a biobank
- Involved in setting up a medical databank e.g. a patient registry
- nvolved in maintaining and upholding a biobank or medical databank
- Lobbying for the setting up of a biobank or a medical databank on the condition that is represented by your patient organisation
- (co)Financing a biobank or a medical databank
- Raising funds for a biobank or a medical databank on the condition that is represented by your patient organisation
For the distribution of the survey, we made use of PatientView's database of 80,000 patient groups and organisations from around the world (the database sources its details of listed groups from the public domain). The survey was distributed by sending an invitation email in English to the database's European national patient groups and organisations (+/- 12,000), asking for their cooperation in taking part in the survey. The invitation and survey were made available in 5 European languages; English, Dutch, French, German and Spanish through the PatientPartner project’s website www.patientpartner-europe.eu.
Please click here for the invitation (in english)
Please click here for the survey (in english)
The respondents were asked to answer the questions from the perspective of the patient organisation in which they are involved, either as a member, advisor or representative.
The responses taken from the survey were translated into English before being analysed. All descriptions have been made unidentifiable as agreed with the respondents at the beginning of the survey.
Furthermore we present a comparative analysis*, based on the difference between patient organisations in two categories :
- Region; Central Eastern, North-Western and Southern Europe for definition please click here
- The category of disease they represent; Rare or Common condition for definition please click here
The results of the survey have been described per level of involvement in clinical trials in the survey's results tab. Per level of involvement the overall results are discussed as well as the differences between in involvement between patient organisations from the three European Regions ( North-Western, Southern and Central and Eastern Europe as well as looking at the differences between patient organisations representing either a “common” or “rare” condition.