Culture and Process Change as a Priority for Patient Engagement in Medicines Development

Therapeutic Innovation and Regulatory Science

Volumn 51, Issue 1, 2017, Pages 29-38

  Boutin, Marc ^a   Dewulf, Lode ^b   Hoos, Anton ^c   Geissler, Jan ^d   Todaro, Veronica ^e   Schneider, Roslyn F ^f   Garzya, Vincenzo ^g   Garvey, Andrew ^h   Robinson, Paul ⁱ   Saffer, Tonya ^j   Krug, Sarah ^k   Sargeant, Ify ^l  

^a National Health Council   (United States)

^b UCB PHARMA   (Belgium)

^c AMGEN INC   (United States)

^d European Patients Academy on Therapeutic Innovation   (Belgium)

^e Parkinson's Disease Foundation   (United States)

^f PFIZER INC   (United States)

^g ASTRAZENECA   (United Kingdom)

^h GLAXOSMITHKLINE   (United Kingdom)

ⁱ Merck Sharp & Dohme Limited   (United Kingdom)

^j National Kidney Foundation   (United States)

^k Cancer Research Foundation   (United States)

^l Ismedica Ltd   (United Kingdom)

more..

Author keywords

patient engagement priorities medicines development

Indexed keywords

ARTICLE; CONCEPTUAL FRAMEWORK; CULTURAL ANTHROPOLOGY; DRUG DEVELOPMENT; HUMAN; INFORMATION SYSTEM; LEARNING; NON PROFIT ORGANIZATION; PATIENT ADVOCACY; PATIENT ATTITUDE; PRIORITY JOURNAL; PROCESS DEVELOPMENT;

EID: 85009508804     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479016659104     Document Type: Article

References (47)

1. Health Research Authority (HRA). Assessing professional and public opinion of the HRA. http://www.hra.nhs.uk/documents/2015/03/assessing-professional-public-opinion-hra-2015.pdf. Accessed February 13, 2016.
2. Key milestones of EMA interaction with patients and consumers. http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000317.jsp&mid=WC0b01ac058003500c. Accessed May 31, 2016.
3. EMA Press Release, December 9, 2015. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2015/12/WC500198366.pdf. Accessed January 5, 2016.
4. EU Medicines Agencies Network Strategy to 2020. Working together to improve health. EMA/MB/151414/2015. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/12/WC500199060.pdf. Published December 17, 2015. Accessed January 5, 2016.
5. EMA News Release, September 21, 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/09/news_detail_002394.jsp&mid=WC0b01ac058004d5c1. Accessed January 5, 2016.
6. EMA. Incorporating patients’ views during evaluation of benefit: risk by the EMA Scientific Committees. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/09/WC500173508.pdf. Published October 23, 2014. Accessed February 13, 2016.
7. About the FDA Patient Network. http://www.fda.gov/forpatients/about/default.htm. Accessed May 21, 2016.
8. Food and Drug Administration. Patient-Focused Drug Development: Disease Area Meetings Planned for Fiscal Years 2013-2017. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm. Accessed March 2, 2016.
9. Food and Drug Administration. Externally-Led Patient-Focused Drug Development Meetings. A Notice by the Food and Drug Administration. https://www.federalregister.gov/articles/2015/12/28/2015-32476/externally-led-patient-focused-drug-development-meetings. Published December 28, 2015. Accessed February 13, 2016.
10. Food and Drug Administration. FDA Voice. FDA Announces First-ever Patient Engagement Advisory Committee. Posted September 18, 2015. http://blogs.fda.gov/fdavoice/index.php/2015/09/fda-announces-first-ever-patient-engagement-advisory-committee/. Accessed January 5, 2016.
11. Center for Devices and Radiological Health (CDRH) strategic priorities for 2016-2017. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM481588.pdf. Accessed February 8, 2016.
12. Food and Drug Administration. Califf: FDA Workforce, Data Gathering, Patient Engagement Top Priorities. http://www.meddeviceonline.com/doc/califf-fda-workforce-data-gathering-patient-engagement-top-priorities-0001. Accessed March 2, 2016.
13. Canadian Agency for Drugs and Technologies in Health. CADTH Common Drug Review Patient Input. https://www.cadth.ca/about-cadth/what-we-do/products-services/cdr/patient-input. Accessed March 2, 2016.
14. Canadian Agency for Drugs and Technologies in Health. CADTH 2015-2018 Strategic Plan. Informing choices in a new era of health care in Canada. https://www.cadth.ca/about-cadth/how-we-do-it/planning-documents. Accessed March 2, 2016.
15. Canadian Agency for Drugs and Technologies in Health. CADTH Scientific Advice Program. https://scientificadvice.cadth.ca/. Accessed March 2, 2016.
16. National Institute for Health and Care Excellence (NICE): Patient and Public Involvement Policy. https://www.nice.org.uk/about/nice-communities/public-involvement/patient-and-public-involvement-policy. Published November 2013. Accessed February 12, 2016.
17. European Patients’ Forum. Patient Involvement in Health Technology Assessment in Europe. Results of the EPF Survey (2013). http://www.eu-patient.eu/globalassets/projects/hta/hta-epf-final-report2013.pdf. Accessed February 12, 2016.
18. Hoos A, Anderson J, Boutin M. Partnering with patients in the development and lifecycle of medicines: a call for action. Therapeutic Innovation & Regulatory Science. 2015;49:929–939.
19. National Health Council/Genetic Alliance. Advancing Meaningful Patient Engagement in Research, Development, and Review of Drugs. http://www.nationalhealthcouncil.org/sites/default/files/PatientEngagement-WhitePaper.pdf. Published September 2015. Accessed March 2, 2016.
20. University of Maryland Center for Excellence in Regulatory Science and Innovation (CERSI). Stakeholder Perspectives on Patient-Focused Drug Development: Insights from FDA, Patients, Industry, and Payers. 2015. http://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/pfdd/mcersi-pfdd-proceedings.pdf. Accessed March 2, 2016.
21. Perfetto EM, Burke L, Oehrlein EM, Epstein RS. Patient-focused drug development: a new direction for collaboration. Med Care. 2015;53:9–17.
22. Nichols E, ; Institute of Medicine (US) Roundtable for the Development of Drugs and Vaccines Against AIDS. Expanding Access to Investigational Therapies for HIV Infection and AIDS: March 12–13, 1990 Conference Summary. Washington, DC: National Academies Press; 1991. 1, Historical Perspective. http://www.ncbi.nlm.nih.gov/books/NBK234129/. Accessed May 31, 2016.
23. EURORDIS. Mission and achievements. http://www.eurordis.org/content/mission-and-achievements. Accessed May 31, 2016.
24. Gamble C, Dudley L, Allam A. Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open. 2014;4:e005234.
25. Buck D, Gamble C, Dudley L. From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials. BMJ Open. 2014;4:e006400.
26. Parkinson’s Disease Foundation (PDF) Parkinson’s Advocates in Research (PAIR) Leadership Awards. http://www.pdf.org/en/grant_funding_apt#pair. Accessed February 13, 2016.
27. Patient-Centered Outcomes Research Institute (PCORI). http://www.pcori.org/research-results/evaluating-our-work. Accessed February 13, 2016.
28. Parsons S, Starling B, Mullan-Jensen C, Tham SG, Warner K, Wever K. What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study. BMJ Open. 2016;6:e008928.
29. Code of Practice 2007. Code of practice between patients’ organisations and the healthcare industry (EU) 2007. http://www.eurordis.org/sites/default/files/thumbnails/0904-PO-Code%20of%20practice.pdf. Accessed March 2, 2016.
30. EFPIA Code of practice on relationships between the pharmaceutical industry and patient organisations 2011. http://transparency.efpia.eu/uploads/Modules/Documents/code_po2011.pdf. Accessed March 2, 2016.
31. IFPMA Code of Practice 2012. http://www.ifpma.org/resource-centre/ifpma-code-of-practice/. Accessed March 2, 2016.
32. Smith SK, Selig W, Harker M. Patient engagement practices in clinical research among patient groups, industry, and academia in the United States: a survey. PLoS One. 2015;10:e0140232.
33. Gallin EK, Bond E, Califf RM. Forging stronger partnerships between academic health centers and patient-driven organizations. Acad Med. 2013;88:1220–1224.
34. Merrill Corporation, BayBio. Successful public-private partnerships: a guide to effective patient foundation and life science industry collaborations. White paper. http://bit.ly/1C5mqnH. Published 2013. Accessed March 2, 2016.
35. Dewulf L. Patient engagement by pharma—why and how? A framework for compliant patient engagement. Therapeutic Innovation & Regulatory Science. 2015;49:9–16.
36. Clinical Trials Transformation Initiative (CTTI) Patient Groups & Clinical Trials (PGCT) Project. CTTI recommendations: effective engagement with patient groups around clinical trials. http://www.ctti-clinicaltrials.org/files/PatientGroups/PGCTrecs.pdf. Released October 2015. Accessed January 5, 2016.
37. Patient-Centered Outcomes Research Institute (PCORI) Engagement Rubric. http://www.pcori.org/sites/default/files/Engagement-Rubric.pdf. Published February 4, 2014. Updated October 13, 2015. Accessed January 24, 2016.
38. British Medical Journal 2014. Partnering With Patients Campaign. http://www.bmj.com/campaign/patient-partnership. Accessed January 5, 2016.
39. Richards T, Snow R, Schroter S. Logging the BMJ’s “patient journey.” BMJ. 2015;351:h4396.
40. De Wit MP, Berlo SE, Aanerud GJ. European League Against Rheumatism recommendations for the inclusion of patient representatives in scientific projects. Ann Rheum Dis. 2011;70:722–726.
41. Parsons S, Starling B, Mullan-Jensen C. What the public knows and wants to know about medicines research and development: a survey of the general public in six European countries. BMJ Open. 2015;5:e006420.
42. Parent Project Muscular Dystrophy (PPMD). PPMD Submits Results of Patient-Centered Benefit-Risk Assessment Study in Duchenne & Becker to FDA. http://community.parentprojectmd.org/profiles/blogs/ppmd-submits-results-of-patient-centered-benefit-risk-assessment-?xg_source=Connect_news. Accessed January 26, 2016.
43. Food and Drug Administration. FDA issues draft guidance on developing drugs for Duchenne Muscular Dystrophy. http://www.fda.gov/Drugs/DrugSafety/ucm448894.htm. Accessed March 2, 2016.
44. Jakab Z., The future of health care in Europe. Presented at The Economist Conference Geneva, Switzerland. http://www.euro.who.int/__data/assets/pdf_file/0010/135586/RD_speech_Economist_20110317.pdf. Published March 17, 2011. Accessed March 2, 2016.
45. Wicks P, Vaughan T, Heywood J. Subjects no more: what happens when trial participants realize they hold the power? BMJ. 2014;348:g368.
46. The Future of Healthcare in Europe. Meeting future challenges: key issues in context Policy briefing. file:///C:/Users/ifydell/Documents/work%202015/PFMD/Priority%20pub/priority%20pub%20refs/FHE_FINAL_online.pdf. Accessed March 2, 2016.
47. Health Policy Brief: Patient Engagement. Health Affairs, February 14, 2013. http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=86. Accessed March 2, 2016.