Involvepresentation
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The document discusses patient involvement in pharmaceutical research and development. It describes the European Patients' Academy project, which aims to build patient and public competencies and facilitate their involvement in research. The findings of a qualitative study on pharmaceutical industry professionals' beliefs are presented. While most believed patients should be involved, there were few concrete plans and uncertainty around how to operationalize involvement. Challenges included patients' research knowledge and distrust of industry. Facilitators included increased transparency and revised codes of practice. The discussion focuses on lessons to be learned across public and private research and recommendations for meaningful patient involvement.
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Involvepresentation
- 1. Bella Starling and Suzanne Parsons, Public Programmes Team Central Manchester Universities NHS Trust and the University of Manchester Public involvement in pharmaceutical research and development – can we move beyond Bad Pharma? The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
- 2. Background • Increased complexity of medicines R&D may have impacted on the speed of bringing medicines to patients • Importance of identifying ways to improve the sustainability and usefulness of medicines R&D • Increased patient and public involvement has been suggested as a key approach to this
- 3. European Patients’ Academy: Paradigm shift in empowering patients on medicines R&D Launched Feb ’12, runs for 5 years,30 consortium members,Funded by IMI JU Will develop and disseminate objective, credible, correct and up-to-date public knowledge about medicines R&D Will build competencies & expert capacity among patients & public Will facilitate patient involvement in R&D to collaborate in academic research, industry research, authorities and ethics committees
- 4. Aims • To describe the findings of a qualitative study exploring the beliefs of pharmaceutical industry professionals about patient involvement in medicines R&D • To describe the work that EUPATI is leading to facilitate more active patient involvement in medicines R&D
- 5. Design and method Qualitative case studies of key stakeholders in medicines R&D Undertaken in the UK, Spain and Poland and on a pan-European basis Mixture of focus groups and one to one interviews conducted in each country with Patient representatives Patients and the public Clinical research professionals Policy makers Pharmaceutical industry professionals Interviews with Pharmaceutical industry professionals explored Interviewees contact with the public in day to day role Beliefs about patients and the public's understanding of and information needs regarding medicines R&D Experiences of involving patients if any Beliefs about barriers and facilitators to patient involvement in medicines R&D
- 6. Findings • 21 pharmaceutical industry representatives participated 1) UK (6) 2) Pan-European roles (3) 3) Spain (4) 4) Poland(8) • Key themes –Should patients and the public become involved in medicines R&D? –Does industry’s current relationship with patient groups need to change to facilitate patient involvement? –What are the challenges and facilitators to patient involvement in medicines R&D?
- 7. Should patients and the public become involved in medicines R&D? + Ideas about how to involve + No idea how to involve - Patients should not be involved ALL BELIEVED FEW WIDESPREAD AND CONCRETE PLANS WITHIN INDUSTRY ON HOW TO INVOLVE PATIENTS
- 8. Changing relationships between patients and industry Current relationship Some little patient contact. Others more depending on job function Sponsor of patient group activities Future relationship Decreased distance between patients and industry Increased patient involvement and partnership working, less emphasis on sponsorship Facilitators of relationship change Revision of existing professional code Increased opportunities for patients to become involved Increased readiness of industry to involve patients in medicines R&D
- 9. Challenges and facilitators to patient involvement Challenges and facilitators to patient involvement Knowledge of R&D Low knowledge can lead to distrust Disagreement over level and amount of information needed for involvement Patient related factors Interest in meds R&D Less interest if well- established treatment for condition Less interest if distrust industry Importance of increased transparency to dispel distrust Pharmaceutical industry related factors Understanding of and interest in involvement Uncertainty regarding aims, function and value of patient involvement Beliefs about how to make patient involvement happen Little clarity regarding which types of patients to involve and how to involve them
- 10. 01/21/15 “We work with patient associations and the last one that I did started in 2001, and it’s amazing how things have changed in that the work that we were able to do together with the patient association then would be completely not allowed with today’s world. It was a much more intimate involvement in what we were doing and now whenever we discuss what we’re doing, it’s considered that we might be enticing them to take a drug.. “
- 11. Patient organisations & industry workshop: “Meaningful patient involvement in industry-led R&D” 23 July 2014 Turning aspirations into reality: •Benefits and impact of involving patients and advocates in the R&D process •Common concerns, hurdles and solutions •Codes of Practice Develop guidance, framework, key indicators. 20 case studies published in public domain!
- 12. Beyond EUPATI: Creating sustainable impact beyond 2016
- 13. Discussion areas • What has your experience been of patient involvement in pharmaceutical industry led research? • What can industry learn from public involvement in the NHS, public and social care research and vice versa? • What are the important differences between patient involvement in publically sponsored research and involvement in industry sponsored research?
- 14. Discussion areas • What are the opportunities and challenges for patient involvement in pharmaceutical medicines research and development? • What are your top five recommendations for ways forward for patient involvement in pharmaceutical medicines research and development?
Editor's Notes
- Biopharmaceutical industry needing to develop more complex molecules and medicines that show improved outcomes for diseases for which there is currently a significant unmet need. Pressure to develop more complex molecules has arisen partly due to the patent expiration of a number of widely used and important prescription medicines. Therefore, the increased complexity and cost of the medicines R&D process has resulted in fewer new medicines being brought to market, higher prices for those new medicines that are introduced and medicines access problems for patients with a wide range of conditions. PPI proposed as one way of doing this, as it is believed to improve the process by making it more patient-centred, promoting innovation by identifying new research areas, and by providing new insights and potential solutions to existing problems within medicines R&D.
- Interviews in the UK and pan-European interviews undertaken by UoM who commissioned subcontractors in Spain and Poland to undertake interviews in these countries Interviews undertaken with …. Current presentation focuses on interviews undertaken with pharmaceutical industry professsionals and covered the following areas
- Some interviewees felt positively about patient and public involvement and had some ideas about how to involve patients, for example adapting existing mechanisms by which they currently involve other stakeholders such as physicians Others described themselves as being positive about patient involvement, but unfortunately where unable to describe or suggest any clear ideas on how they should involve patients Finally others felt very negatively about patient involvement, or did not seem to be able to envisage how patients could have a role A common finding across all countries was that participants felt that there was currently few widespread and concrete plans wiwithin industry on how to invovlve patients
- Participants discussed their current relationship with patients and if they felt positively about patient involvement they also discusseed how their relationship needed to change in the future in order to faciliatiate patient involvement
- Participants spoke at length within the interviews about what they felt where the challenges and faciliators to patient involvement in medicines R&D The challenges and faciliators could usefully be separated into those related to patients and to those related to the pharmaceutical industry Pharmaceuitcal industry professionals thought that low public knowledge of medicines R&D could lead to distrust in the pharmaceucitcal industry. They also felt that it was difficult to agree on the level and amount of information needed for patients to become effectively involved The other key patient related factor from participants’ perspectives was the actual level of interest that the public had in medicines R&D – they felt that if they were not interested that it would be difficult to engage them, but they also felt that the vast majority of the public would not be interested unless they became unwell or because they distrusted industry They felt that the pharmaceuitcal industry related factors where The level of understanding of patient involvement within the pharmaceutical industry and their lack of understanding and concrete plans to make patient involvement happen
- Finish with a quote from a pharmaceutical industry representative reflecting on how his relationship with patients has changed and where the challenges are in more effective joint working I will now hand you over to Bella who is going to describe EUPATI’s efforts to faciliate patient invovlement in pharma industry
- Workshop bringing together 56 representatives from patient organisations and industry partners involved in EUPATI to generate dialogue within the project about patient involvement in industry-led R&D: the benefits; current barriers (real or perceived); and frameworks that need to updated to enable smooth and transparent partnerships with patients. This workshop starts a dialogue within the project to provide a landscape ready for EUPATI trainees and other patients to have meaningful opportunities to be involved in research and is a catalyst for all stakeholders to create an environment where this can happen. One key output of this workshop has been the publication of 20 case studies of patient involvement in industry R&D across the medicines lifecycle. You can view these and the full report via the EUPATI website. http://www.patientsacademy.eu/index.php/en/news/361-patient-involvement-in-industry-r-d-from-theory-to-reality
- During the workshop’s three breakout groups it became very clear how important it is to share, collaborate, guide and advocate (to the outside world, but also within companies and institutions) to move patient involvement in R&D into widely adopted practice. It is a huge challenge and there is much to do. In recognition that EUPATI can’t do everything, the participants came together in a final session to discuss outcomes of these discussions and identify priority activities that should be implemented. After a group vote, the key activities identified were: Develop a framework for patient involvement: With the goal being to develop one set of guidelines for all parties (including regulators). Clearly make the case for why patient involvement benefits research: Working group to scope out key actions to document and communicate the impact and benefits of patient involvement. Outline the steps needed to involve patients and advocates: Create a simple ‘how to’ check list for patient involvement in each phase of R&D. Create key performance indicators for patient involvement: Develop measures that cover quality, quantity and speed. A number of volunteers have been scoping these various activities to move them forward as actions during the autumn through dedicated working groups within the project, to involve a number of key external stakeholders and horizon scan to see where there are opportunities to collaborate. Using the workshop as a backdrop, EUPATI is building on these discussions and recently held its first webinar in November for its network members to broaden the dialogue on the topic of patient involvement in clinical research; the ‘framework’ activity is now rolled up into the project’s sustainability work package within one of the key project deliverables; both EUPATI Executive Committee and the industry partners will be holding broader discussions about all four key activities during their meetings this December. Further webinars on patient involvement in ethics commitees and HTA are planned from February 2015 onwards. Webinar Nov 5 recording link now on EUPATI website at: http://www.patientsacademy.eu/index.php/en/news/401-improving-paitnet-involvement-report-recording