Patient Engagement at a Tipping Point—The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products”
Tóm tắt
Từ khóa
Tài liệu tham khảo
Patient-Centered Outcomes Research Institute (PCORI). PCORI engagement rubric. http://www.pcori.org/sites/default/files/Engagement-Rubric.pdf. Published February 4, 2014. Accessed May 28, 2016.
Clinical Trials Transformation Initiative. Best practices for effective engagement with patient groups around clinical trials. http://www.ctti-clinicaltrials.org/what-we-do/investigational-plan/patient-groups. Accessed May 28, 2016.
Smith SK, Selig W, Harker M, et al. Patient engagement practices in clinical research among patient groups, industry, and academia in the United States: a survey. PLoS One. 2015;10:e0140232.
National Institutes of Health (NIH) Clinical and Translational Science Awards Consortium—Community Engagement Key Function Committee Task Force on the Principles of Community Engagement. Principles of Community Engagement. 2nd ed. http://www.atsdr.cdc.gov/communityengagement/pdf/PCE_Report_508_FINAL.pdf. Published June 2011. Accessed May 28, 2016.
Institute of Medicine (IOM). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001.
Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998;1:2–4.
McCaffery J, Smith SK, Wolf M. The challenge of shared decision making among patients with lower literacy: a framework for research and development. Med Decis Making. 2010;30:35–44.
Brach C, Keller D, Hernandez LM, et al. Ten attributes of health literate health care organizations. http://www.ahealthyunderstanding.org/Portals/0/Documents1/IOM_Ten_Attributes_HL_Paper.pdf. Published June 2012. Accessed May 28, 2016.
National Academies of Sciences, Engineering and Medicine. Health Literacy and Consumer-Facing Technology: Workshop Summary. Washington, DC: National Academy Press; 2015:82.
Hoos A, Anderson J, Boutin M, et al. Partnering with patients in the development and lifecycle of medicines: a call for action. Therapeutic Innovation & Regulatory Science. 2015;49:929–939.
Stiggelbout AM, van der Weijden T, De Wit MPT, et al. Shared decision-making: really putting patients at the centre of healthcare. BMJ. 2012;344:e256.
Agency for Healthcare Research and Quality. SHARE approach curriculum tools. http://www.ahrq.gov/professionals/education/curriculum-tools/shareddecisionmaking/tools/index.html. Published September 2015. Accessed May 28, 2016.
Health Canada decision-making framework for identifying, assessing, and managing health risks. http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/risk-risques_tc-tm-eng.php. Published August 1, 2000. Accessed May 28, 2016.
National Health Council and Genetic Alliance. Dialogue: advancing meaningful patient engagement in research, development, and review of drugs. http://www.nationalhealthcouncil.org/sites/default/files/PatientEngagement-WhitePaper.pdf. Published September 22, 2015. Accessed May 28, 2016.
Chakradhar S. Training on trials: patients taught the language of drug development. Nat Med. 2015;21:209–210.
Davis RE, Jacklin R, Sevdalis N, Vincent CA. Patient involvement in patient safety: what factors influence patient participation and engagement? Health Expect. 2007;10:259–267.
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.
Silverman B. Patient voices swayed FDA’s Imlygic review team. www.pharmamedtechbi.com/publications/the-pink-sheet/78/17/patient-voices-swayed-FDAs-emImlygicem-Review-Team?result=3&total=24&searchquery=%253fq%253dImlygic. Published April 25, 2016. Accessed May 28, 2016.
FasterCures, a center of the Milken Institute. Expanding the science of patient input: pain points and potential. http://www.fastercures.org/assets/Uploads/Patients-Count-workshop.pdf. Published 2016. Accessed May 28, 2016.
Hunter NL, O’Callaghan KM, Califf RM. Engaging patients across the spectrum of medical product development: view from the US Food and Drug Administration. JAMA. 2015;314:2499–2500.
Food and Drug Administration. Prescription drug information for patients: history. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM150262.pdf. Accessed May 28, 2016.
Regulatory Affairs Professionals Society. Patient-focused drug development tracker. http://www.raps.org/Regulatory-Focus/News/2014/12/19/19640/Patient-Focused-Drug-Development-Tracker/. Published July 1, 2015. Accessed May 28, 2016.
FDA Safety and Innovation Act of 2012, Pub. L. 112-144. http://www.gpo.gov/fdsys/pkg/FR-2014-11-04/html/2014-26145.htm. Published November 4, 2014. Accessed May 20, 2016.
FDA Center for Devices and Radiological Health. Patient preference information—submission, review in PMAs, HDE applications, and de novo requests, and inclusion in device labeling. Draft guidance for industry, Food and Drug Administration staff, and other stakeholders. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446680.pdf. Published May 18, 2015. Accessed May 28, 2016.
European Medicines Agency. Pharmacovigilance legislation. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000491.jsp&mid=WC0b01ac058058f32d. Published 2010. Accessed May 28, 2016.
Bonini S, Eichler HG, Wathion N, Rasi G. Transparency and the European Medicines Agency—sharing of clinical trial data. N Engl J Med. 2014;371:2452–2455.
Borup G, Bach KF, Schmiegelow M, Wallach-Kildemoes H, Bjerrum OJ, Westergaard N. A paradigm shift towards patient involvement in medicines development and regulatory science: workshop proceedings and commentary. Therapeutic Innovation & Regulatory Science. 2016;50:304–311.
Hammad TA, Neyarapally GA. Regulatory and legislative policy and science considerations in the era of patient-centeredness, big data, and value. In: Jiang Q, He W, eds. Benefit-Risk Assessment Methods in Medicinal Product Development: Bridging the Qualitative and Quantitative Assessments. Boca Raton, FL: CRC Press Taylor and Francis Group; 2016.
ICH final concept paper. M4E(R2): enhancing the format and structure of benefit-risk information in ICH M4E(R1) guideline. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4E_R2_Efficacy/M4E_R2__Final_Concept_Paper_27_March_2015.pdf. Published March 23, 2015. Accessed May 28, 2016.
Medical Device Innovation Consortium (MDIC) patient-centered benefit-risk project report. A framework for incorporating information on patient preferences regarding benefit and risk into regulatory assessments of new medical technology. http://mdic.org/wp-content/uploads/2015/05/MDIC_PCBR_Framework_Web1.pdf. Published 2015. Accessed May 28, 2016.
21st Century Cures Act. Discussion document. 114th Congress. http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Analysis/Cures/20150127-Cures-Discussion-Document.pdf. Published January 26, 2015. Accessed May 28, 2016.
White House press release. Fact sheet: President Obama’s precision medicine initiative. https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative. Published January 30, 2015. Accessed May 28, 2016.
Hammad TA, Neyarapally GA, Iyasu S, Staffa JA, Del Pan G. The future of population-based postmarket drug risk assessment: a regulator’s perspective. Clin Pharmacol Ther. 2013;94:349–358.