Executive Summary
Methodology
- 12000 National patient organisations were contacted by email inviting them to take part in the survey on the involvement of patient organisations in clinical trials between October and December 2008.
- The survey consisted of 24 questions, asking patient organisations about their involvement in clinical trials on the following levels:
a. as a research subject
b. as an information provider
c. as an advisor
d. as a reviewer
e. as a co-researcher
f. as a driving force
- The survey also asked patient organisations to state their experience in being involved in clinical trials with children and in Biobanking and medical databanks.
- The survey and invitation were made available in five different European languages: English, German, Dutch, Spanish and French and could be filled in online through a subsequent weblink that was made available on the website www.patientpartner-europe.eu
General results
- 205 Patient organisations out of the contacted 12000 nationally active patient organisations participated in the survey.
- The respondents represented 30 countries from across Europe.
- 50% of the responding patient organisations represented a common condition and 50% a rare condition.
- 11% of all respondents had no experience in being involved, on any level, in clinical trials and research.
- 79% of all respondents have been/is involved in clinical trials and research on more than one level.
- A quarter of all responding patient organisations have been involved as a research subject, as an advisor, as a reviewer, as a co-researcher or a driving force.
- Half of all respondents are actively involved in clinical trials and research through the providing of information.
Overall results in more detail, looking at the specific actions within the levels of patient involvement
- A third of all respondents have been research subject themselves or know of members of their patient organisation that have taken part in a clinical trial.
- The majority (65%)of the responding patient organisations are/have been actively involved in providing of information on the possibilities to take part in a clinical trial to their members as well as also half (49 %)of the respondents providing disease specific information on their member base to different stakeholders for the use in clinical trials.
- 37% of all respondents give/have given advice on the content and explanation of informed consent forms as well as an equal amount of respondents having reviewed patient information leaflets.
- 42% of all respondents have obtained experience in translating research results into patient friendly information, one of the levels of being a co-researcher.
- 39% of all respondents are involved as a driving force behind a clinical trial, lobbying for (the development of) clinical trials for the condition their organisation represents.
The involvement of patient organisations in clinical trials with children
- The majority (82%) of all responding patient organisations have no experience in being actively involved in clinical trials with children
The involvement of patient organisations in Biobanking and medical databanks
- The majority of all patient organisations (84%) have no experience of being actively involved in Biobanking and medical databanking.
Comparing the involvement of patient organisations from the different European Regions
Overall results
- The respondents were based for 58% in North-Western Europe, 23% in Southern Europe and 12% in Central and Eastern Europe.
- A higher frequency of respondents (20% ) from Central and Eastern Europe stated to have no experience in being involved in clinical trials and research in comparison to respondents from the other two regions (+/- 10%).
- Respondents from Southern Europe showed a higher frequency of being involved in all levels of patient involvement in clinical trials and research when compared to respondents from the other two regions.
- Respondents from North-Western Europe showed to have more experience in being actively involved on the level of being a research subject.
- Respondents from Southern Europe showed a higher frequency of being involved on the levels of being an advisor, co-researcher and driving force in comparison to the respondents from the other two regions.
Results in more detail, looking at the specific actions within the levels of patient involvement
- Patient Organisations (and their members) representing countries from North-Western Europe are more frequently involved...................................
? in helping with the recruitment of patients to clinical trials
? as a contributor to a biobank or a medical database to be used in a clinical trial
? in the reviewing of a funding request
- Patient Organisations (and their members) representing countries from North-Western Europe are less frequently involved ...............................................
? in interviewing patients
? in gathering information for the use in clinical trials
? in translating research results into patient friendly information
? in leading focus groups
- Patient Organisations (and their members) representing countries from Central and Eastern Europe are more frequently involved....................................
? in reviewing patient information that is to be used in a clinical trial
? in reviewing scientific papers on a clinical trial
- Patient Organisations (and their members) representing countries from Central and Eastern Europe are less frequently involved....................................
? as a research subject in a clinical trial
? in contributing to a biobank or a medical database that is to be used in a clinical trial
? in giving advice to a clinical research program committee
? in developing a clinical trial research protocol
? in getting a research team together
- Patient Organisations (and their members) representing countries from Southern Europe are more frequently involved............................
? in supplying demographic and/or other characteristic information for the use in a clinical trial
? as advisor on informed consent forms, in ethics committees and National and European Regulatory committees.
? in raising funds for a clinical trial
? in co-financing a clinical trial
? in getting a research team together
- Patient Organisations (and their members) representing countries from Southern Europe show no further differences in the level of patient involvement when compared to patient organisations from North-Western and Central and Eastern Europe.
The involvement of patient organisations in clinical trials with children
- No differences in the involvement of patient organisations in clinical trials with children, could be identified between European regions, on the levels if being a research subject, an information provider or a reviewer.
- Patient organisations from Central and Eastern Europe showed to be less frequently involved as an advisor in clinical trials with children while patient organisations from Northern and Western Europe tended to be less frequently involved as a driving force and co-researcher.
The involvement of patient organisations in Biobanking and medical databanks
- Overall no difference in the frequency of involvement in Biobanking and medical databanks could be identified, between European regions, on the levels of being a contributor to, setting up of, or lobbying for the setting up of a biobank or medical databank.
- Central and Eastern Europe tend to be less frequently involved in the setting up, maintaining and co-financing of biobanks or medical databanks.
Comparing the involvement of patient organisations representing either “common” or “rare” conditions
Overall results
- Patient organisations representing a “rare” condition showed a higher frequency of being involved on the level of being research subject whilst being less frequently involved as an advisor, in comparison to patient organisations that represent a “common” condition.
- Patient organisations representing a “common” condition showed a higher frequency of being involved on the level of being a reviewer in comparison to patient organisations that represent a “rare” condition.
Results in more detail, looking at the specific actions within the levels of patient involvement
- Patient Organisations (and their members) representing “Common” conditions are more frequently involved .........................
? In giving advice or being an (advisory member) of a clinical research program committee
? In co-writing a scientific article on the research results of a clinical trial
? In gathering research data
? In interviewing patients and leading focus groups
- Patient Organisations (and their members) representing “Rare” conditions are more frequently involved .........................
? As a research subject in a clinical trial
? By contributing DNA, cells and other biological material for the use in a clinical trial
? As a contributor to a biobank or medical database for the use in a clinical trial
The involvement of patient organisations in clinical trials with children
- Respondents from patient organisations that represent a “rare” condition showed a far higher (2-5 times as high) frequency in being involved on all levels of clinical trials with children in comparison to respondents from patient organisations representing the “common” conditions.
The involvement of patient organisations in Biobanking and medical databanks
- Respondents from patient organisations that represent a “rare” condition showed 3 times higher frequency in being involved in Biobanking and medical databanks in comparison to respondents from patient organisations representing the “common” conditions.
Conclusion
Although there are differences in the levels of involvement between European regions;
There is involvement of patient organisations on all levels of clinical trials and research,in all European regions, with room for improvement in all European regions in the near future.
Overall results
205 individual patient organisations from around Europe responded to the survey, representing patient groups from 31 European Countries; 58% from the North-western European region (for region definitions please click here), 23% from the Southern European region , 12% from the Central European Region,2 % from outside Europe and 5% of the respondents chose not to reveal their region. The responding organisations represented the Common (47%) and Rare (51%) disease in an equal number.
11% of all respondents have had no experience in being involved, on any level or otherwise, in clinical trials and research. Whilst 10% of all respondents had experience in being involved on a single level,79% of all respondents showed to be involved on more than one level. Finally 24% of all respondents were involved on all of the described levels of patient involvement.
More information on the demographics of the responding patient organisations can be found by clicking on the sections below
Patient organisations and their country of origen :
Overall
North-Western Europe
Central and Eastern Europe
Southern Europe
List of European Country abbreviations
Patient organisations and their disease specifity, overall and per region, click here
The function within the patient organisation of the respondents (overall) click here
The size (in number of members) of the responding patient organisations (overall) click here
For the full report please click here