"EUPATI – EU: An overview", held by Bella Starling & Suzanne Parsons (EUPATI / Nowgen) at the EUPATI-UK Network Conference on 6 March 2014 in Leeds, UK

1. Bella Starling and Suzanne Parsons on behalf of Work Package 3 of EUPATI
Nowgen, University of Manchester
Patient involvement in medicines
development – the views of
patients and key stakeholders

2. WP3 - Needs assessment aims
• To explore patient representatives, patients at large and the public‟s
– Current knowledge and awareness of medicines development
– Interest in learning more about or increasing their awareness of the medicines
development process
– Interest in increased involvement in the medicines development process and beliefs
about the factors that may facilitate this
• To explore the perspectives of other key stakeholders in the medicines
development process on
– Patients and the public‟s current knowledge of and interest in the medicines
development process
– Increased patient involvement in the medicines development process

3. Review Work Online Surveys Qualitative Studies
Existing
information
resources for
patients and the
public
Literature review on
patients‟ and the
public‟s
knowledge, attitudes
and beliefs regarding
medicines
development
General public in
GB, Spain, Poland, I
taly, France and
Germany
Patient advocates and
expert patients across
Europe
Of
patients, public, patie
nt
advocates, pharmac
eutical
industry, clinical
research
professionals and
policy makers in
UK, ES, PL
Findings
306 resources
submitted.
230 included in
review.
12600 titles and
abstracts reviewed
134 included in review.
6931 responses
recorded
468 responses from
patient advocates and
expert patients across
Europe
148 reported current
research involvement
and 98 previous
involvement
91 patient advocates
34 members of the
public
13 policy makers
21 pharmaceutical
industry
representatives
23 Clinical research
professionals /
Health care
WP3 Programme of work

4. Findings

6. Influences on PPI in medicines
development
Patient contributors perspectives

7. Patient contributors involvement in
research
 Roles
• Research involvement one part of a multi – faceted role
• Part of role in supporting patients not necessarily well established or externally
recognised
• Perceived lack of clear roles for patients in the medicines development process –
(From both patient representatives and key stakeholders perspectives)
 Relationships
• Good relationships between patient groups, industry and clinical researchers
essential
• Patient contributors spoke at length about the challenges and facilitators of
establishing successful relationships with industry and clinical researchers
• Facilitators
– Existing examples of good practice to build upon
– Increasing importance of patient involvement in medicines development to the
pharmaceutical industry
• Challenges
– Conflicting agendas and ways of working
– Difficulties in establishing trust in one another

8. Patient contributors involvement in
research
 Perceptions of industry and clinical research
• Negative perceptions of industry and clinical research led to
– Fears amongst some patient groups that involvement in medicines
development might taint their reputation
– Decreased receptivity of some patient groups to the material developed by
EUPATI
 Organisational issues
• Structures and organisations involved in medicines development relatively
complex and difficult to navigate
• Perceived lack of involvement opportunities within medicines development and
structures to support involvement
• Need for beacon projects for industry and patients to work together on from
which lessons can be learnt and shared

9. Patient contributors involvement in
medicines development – Culture
 Perceptions of whether patient contributors would be likely to have a
voice in the medicines development process varied across the
countries studied
• E.G. in the UK stronger culture of involvement whereas in Poland a wide level of
distrust in healthcare, concerns about corruption seemed to act as a disincentive to
involvement.
 Related to this, the nature of the doctor patient relationship within each
of the countries seemed to influence willingness to get involved
• E.G. in both Spain and Poland, more traditional models of the Dr-Patient
relationship appeared to still prevail meaning that patients felt that they could be
less questioning and challenging to healthcare professionals about their healthcare

10. Patient and public involvement in
medicines development
Key stakeholders perspectives

11. Key stakeholders perspectives
Roles
 Beliefs about patients‟ roles in the medicines development process
varied
 Some raised the question whether patients had a role
 Others believed that patients could have a role but felt that roles were
currently unclear and needed to be worked out
 Those with experience of involving patients had more concrete ideas
 Those in countries where patient involvement was not widespread had
greater difficulty in outlining roles

12. Key stakeholders perspectives
Characteristics of patient contributors
 Participants talked at length about the characteristics of „good‟ patient
representatives. Ideas included
• Those with experience of committee work
• Those with a well developed knowledge base in this area
• Those who were able to act as impartially as possible and put personal agendas
aside
• Contrasts with patient contributors perceptions that they often became involved due
to their beliefs that there was a particular “battle to be won” with regard to their
condition,
 Those with some experience of involvement talked about some
potential downsides of the „good‟ patient representative
• Lack of diversity in the population involved
• Potential for patient representatives to become over professionalised – leading to
grassroots patients‟ views no longer being represented
• Contrasts with patient contributors perceptions that

13. Key stakeholders and patients
perspectives – Knowledge
 How much knowledge is enough? Key question for both patient
representatives and key stakeholders
 Widespread belief amongst key stakeholders that patient and the
public knowledge levels were low - sometimes amongst patient
groups
 Importance of giving value to patients existing knowledge –(Patients)
 Importance of ensuring that patients‟ do not lose their original and
unique contribution by increasing their knowledge of the more
technical aspects of medicines development too much (Key
stakeholders)

14. Discussion
 Considerable involvement experience amongst the patient contributors
surveyed - useful to build on the existing experience to develop
patient involvement in medicines development
 Need for key stakeholders in medicines development to think more
strategically about patient involvement, e.g. roles and systems to
support involvement
 Importance of analysing and sharing examples of good practice in
patient involvement in medicines development
 Importance of raising key stakeholders understanding and awareness
of the benefits and value of patient involvement in medicines
development
 Importance of developing training and advice not just for patients but
also for those who will be involving patients in the medicines
development process

15. Challenges to patient involvement in
medicines development

16. Final points and thank you
 Other aspect of this work addresses increasing public awareness of
these issues
 Findings presented pending publication
 Many of the findings will be addressed within the EUPATI programme
of work although some findings and recommendations are likely to
require more wide scale activities beyond the scope of EUPATI
Contact details
bella.starling@cmft.nhs.uk
suzanne.parsons@cmft.nhs.uk

17. Public awareness - UK

18. Work Package 3 team
 University of Manchester
 Bella Starling – WP3 lead
 Suzanne Parsons – WP3 Project Manager
 Su-Gwan Tham – WP3 Project Assistant
 GlaxoSmithKline
 Kay Warner – WP3 co-lead
 Novo Nordisk
 Christine Mullan-Jensen – WP3 Deputy Co-lead
 EGAN / GAUK
 Kim Wever
 Celine Lewis
 Amgen, Genzyme, Roche, AstraZeneca, VFA
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