Being involved as an advisor in clinical trials
To give advice is to be asked for your opinion or the opinion of a group that you represent. PatientPartner believes that the patient perspective can bring a new viewpoint to the table in committees that have a advisory function in the clinical trial process. To find out in which way patient organisations are actively involved in an advisory role in the context of clinical trials we asked our respondents
Is (Has) your patient organisation (been) involved in a clinical trial as an advisor?
Overall 25% of all respondents have had experience of some sort in being an advisor in clinical trial and research.
When looking in more detail, the survey shows that providing of advice on informed consent forms is the main advisory task of a patient organisation in clinical trials (37% of all respondents). This category includes the advice given on patient information sheets and leaflets.
18% of the respondents give/have given advice or are an advisory member of an ethics committees. In addition, a more or less equal percentage (20%)of the respondents are actively involved as an advisor on a national or European regulatory committee.
A further 26 % are and advisory member or gives advice in a clinical research program committee, primarily in clinical trial steering committees (e.g. in TRACE RA, DiGem and MINDACT trial).
Respondents provided little information towards the question of who contacted them to provide the advice or take part in an advisory committee e.g. a member of pharmaceutical company or a clinical researcher. Only one of the respondents commented that they had given advice to a pharmaceutical company.
Other described ways of giving advice in clinical trials ranged from providing researchers and/or funding bodies with advice on the relevance of research (setting the agenda for research), types of questions that should be researched, the needs for research within their particular patient group and on aspects of patient experiences that could be important for the research study.
A reoccurring theme in the first three levels of involvement seems to be the involvement of patient organisations in the recruitment of patients to clinical trials, as one organisation stated:
“An account advisor from a company that runs medical trials was given information on how she could find volunteers for a certain treatment”.
From the detailed descriptions of some patient organisations some respondents are involved in several advisory committees while the majority of the respondents were asked to provide an single piece of advice on a specific issue.
Please click here for the graph on the involvement of patient organisations as an advisor in clinical trials.
Please click here for examples of clinical trials and research in which patient organisations have been involved on the level of being a advisor,that were described by the survey's respondents
Regional differences in being involved as an advisor in clinical trials
Respondents from the Southern European region show the highest frequency of involvement as an advisor in all subcategories (annex ) as compared to the other 2 regions. In addition respondents from CE Europe tend to less frequently involved in giving advice to or has been a (advisory) member of a clinical research program committee for the development of a clinical trial as compared to the respondents of NW and S Europe.
Overall regions compared
Central and Eastern Europe
Disease-group specific differences in being involved as an advisor in clinical trials
The survey shows that respondents representing a patient organisation for a common condition tend to be more frequently involved in giving advice/being an advisory member in an ethics committee as well as in a clinical research program committee for the development of a clinical trial
Overall comparing the"common" with the "rare" condition patientorganisations
Patient organisations representing the "common" conditions
Patient organisations representing the "rare" conditions