Survey on patient and public involvement in clinical research

Introduction

Patients1 can offer a unique and valuable perspective on research. This patient perspective has the potential to improve the relevance, quality and safety of e.g. clinical trials. It is therefore important for academic research institutions/organisations to involve patients/patient representatives throughout the whole process of clinical research.

In Switzerland, Patient and Public Involvement (PPI) in academic research is still in its infancy compared to other countries like e.g. the UK. There are some initiatives/projects but the approach is more or less fragmented and not interconnected.


What is patient and public involvement (PPI)?

Patient and public involvement in research2 can be defined as research being carried out ‘with’ or ‘by’ patients and members of the public rather than ‘to’, ‘about’ or ‘for’ them. This means being involved as a full partner in a research project/initiative, as researcher, advisor or responsible for a specific topic/theme including, for example:

working with research funders to prioritise research;
offering advice as members of a project steering group;
commenting on and developing research materials.


Why this survey?

With this survey, the Swiss Clinical Trial Organisation (SCTO)3 together with its partner organisations4 aims to identify and characterise local/national PPI initiatives within research in the academic setting.
The results of the survey will be presented as a mapping of all identified PPI initiatives/projects, as a solid basis of the “status quo” in Switzerland.

 
What is the overall goal?

Based on the “status quo”, the overall goal is to foster and implement PPI within academic clinical research. One possible measure could be to establish a Swiss PPI Hub as central platform with a dedicated Patient Advisory Panel that could be integrated and/or consulted by research organisations, authorities and funders alike. We specifically propose this collaborative approach to avoid that each and every research organisation/institution establishes a Patient Advisory Panel on their own.


What is meant by academic research?

Academic research is research not funded by a for-profit company like a pharmaceutical, biotechnology or medical device company for commercial ends but by public-good institutions/organisations/associations (usually foundations, university hospitals, etc.).

In Switzerland, clinical research falls under the general framework of the Human Research Act (HRA) and its Ordinances5.
Among others, it encompasses the following:

  • Randomised, controlled clinical trials
  • Research on personalised health
  • Epidemiological, observational research
  • Research on data and samples from humans
  • Research on research

Out of scope would be, for example, health system related research.
What happens to my data and the information I provide?

It goes without saying that we handle the data you entrust to us as part of our online survey in a responsible manner and observe all relevant provisions set forth by data protection law. This means that no personal information, e.g. your e-mail address will be provided and there will be no linkage to your name when presenting the results.

We use your responses to the survey for the following purposes:

  • We would like to identify all projects/initiatives that include the patient’s and public perspective in academic research.
  • We would like to present all identified projects/initiatives on our website and in publications in an anonymised way meaning that there is no linkage to your name.
  • We want to raise awareness of PPI and make the patient’s and public voice heard.


Consent statement

In answering this survey, I agree to my information being used for the purposes detailed above. The information will only be accessed by responsible Swiss Clinical Trial Organisation staff.
I understand my data will be held securely and will not be distributed to third parties.


I have the possibility to answer this survey anonymously.
1As defined by EUPATI (https://toolbox.eupati.eu/)

“Individual patients” are persons with personal experience of living with a disease. They may or may not have technical knowledge in R&D or regulatory processes, but their main role is to contribute with their subjective disease and treatment experience.
“Carers” (“Caregivers”) are persons supporting individual patients such as family members as well as paid or volunteer helpers.
“Patient advocates” are persons who have the insight and experience in supporting a larger population of patients living with a specific disease. They may or may not be affiliated with an organisation.
“Patient organisation representatives” are persons who are mandated to represent and express the collective views of a patient organisation on a specific issue or disease area.
“Patient experts”, in addition to disease-specific expertise, have the technical knowledge in R&D and/or regulatory affairs through training or experience, for example EUPATI Fellows who have been trained by EUPATI on the full spectrum of medicines R&D.

2National Institute for Health Research, UK, INVOLVE https://www.invo.org.uk/frequently-asked-questions/

3www.scto.ch

4 Schweizerische Akademie der Medizinischen Wissenschaften (SAMW), Swiss Personalized Health Network (SPHN), Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung (SAKK)

5https://www.fedlex.admin.ch/de/cc/internal-law/81#810.3
 
 10% of survey complete.

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