eprintid: 504
rev_number: 9
eprint_status: archive
userid: 30
dir: disk0/00/00/05/04
datestamp: 2022-01-17 12:12:41
lastmod: 2022-01-17 12:12:41
status_changed: 2022-01-17 12:12:41
type: thesis
metadata_visibility: show
creators_name: Roy, Ria Rose
corp_creators: Supervisor: Gillian McMahon
title: Barriers that Restrict Patient Involvement in Drug Development: An Industrial Perspective
ispublished: submitted
subjects: RS
divisions: MScPBT
full_text_status: public
keywords: patient involvement, drug development, decision making, barriers, patient organisation, patient advocacy groups, patient centered, product lifecycle, regulatory bodies, outcome measures, stakeholders, industrial perspective, clinical research
abstract: Objective:
To explore the barriers restricting the implementation of patient involvement in drug development(PIDD)from an industrial perspective and to get insights on knowledge and awareness of pharmaceutical employees around PIDD and its various facets. 
Methods:
A questionnaire-based survey (n=51) was conducted among the pharmaceutical employees currently working in Research and Development, to seek information regarding barriers pertaining to patient involvement in drug development. The study participants were evaluated for their understanding and awareness around the subject to get insights on the persisting knowledge gaps. The data was analysed descriptively and interpretatively, based on the type of responses obtained. 

Results:
In the study, 74% of the respondents considered lack of dedicated groups as a likely factor hurdling the execution of PIDD. In addition, a total of 62% of the employees corresponded lack of industrial confidence in patient knowledge and skills to hinder the effective industrial implementation of the concept, while 16% of the participants considered proper representation of patient population for PIDD activities unlikely to cause hurdles. Insights on participant’s knowledge and awareness on PIDD and its support organisation, revealed it to beaverage, considering their close associations with drug development activities.  Recommendations for improving the current state of patient involvement in drug development were primarily directed towards enhancing knowledge base around the topic, reforming the current industrial practices to better involve patients and strengthening regulations around PIDD. 

Conclusion:
Despite increasing efforts from patient organisations in promoting PIDD within industrial practices by empowering patients through trainings and by coming up with recommendations to recognize patients as equal partners in the venture, there still exists barriers that hinder its practicality. Bridging the gap between the conceptual theories and functionalism is necessary and requires identifying the factors posing challenges and overcoming them by establishing means to improve patient involvement. Assessing the value of methods offered for PIDD execution, expanding the population range and utilising information from regulatory database to gain insights on the state of PIDD, allows for further research.
date: 2021
date_type: completed
institution: Innopharma
department: Innopharma Faculty of Pharmaceutical Science
thesis_type: masters
referencetext: ...................................................................................................................... 67 - 69 APPENDICES ....................................................................................................................... I-XVIII AND BIBLIOGRAPHY

Agarwal, N. B. and Karwa, M. (2018) ‘Chapter 12 - Pharmaceutical Regulations in India', in Vohora, D. and Singh, G. (eds) Pharmaceutical Medicine and Translational Clinical Research. Boston: Academic Press, pp. 215-231. doi: 10.1016/B978-0-12 802103-3.00013-4.

Barksdale, D. J., Newhouse, R. and Miller, J. A. (2014) ‘The Patient-Centered Outcomes Research Institute (PCORI): Information for academic nursing', Nursing Outlook, 62(3), pp. 192-200. doi: 10.1016/j.outlook.2014.03.001.

Bemt, B. J. F. van den et al. (2019) ‘A portfolio of biologic self-injection devices in rheumatology: how patient involvement in device design can improve treatment experience', Drug Delivery. Taylor & Francis, 26(1), pp. 384-392. doi: 10.1080/10717544.2019.1587043.

CDER, C. for D. E. and R. (2020) ‘CDER Patient-Focused Drug Development', FDA. FDA. Available at: https://www.fda.gov/drugs/development-approval-process-drugs/cderpatient-focused-drug-development (Accessed: 9 April 2021).

CDER, C. for D. E. and R. (2021) ‘CDER Pilot Grant Program: Standard Core Clinical Outcome Assessments (COAs) and their Related Endpoints', FDA. FDA. Available at: https://www.fda.gov/drugs/development-approval-process-drugs/cder-pilot-grantprogram-standard-core-clinical-outcome-assessments-coas-and-their-relatedendpoints (Accessed: 10 May 2021).

CTTI (2015) ‘CTTI RECOMMENDATIONS: EFFECTIVE ENGAGEMENT WITH PATIENT GROUPS AROUND CLINICAL TRIALS'.

Dorocki, S. (2014) ‘Contemporary Trends in the Development of the Pharmaceutical Industry in the World', Studies of the Industrial Geography Commission of the Polish Geographical Society, 25, pp. 108-131. doi: 10.24917/20801653.25.6.

EFPIA (2021) EFPIA Regulatory Road to Innovation. Available at: https://www.efpia.eu/about-medicines/development-of-medicines/regulationssafety-supply/efpia-regulatory-road-to-innovation/ (Accessed: 27 January 2021).

Epstein, S. (1995) ‘The Construction of Lay Expertise: AIDS Activism and the Forging of Credibility in the Reform of Clinical Trials', Science, Technology, & Human Values, 20(4), pp. 408-437. doi: 10.1177/016224399502000402.

Feeney, M. et al. (2020) ‘Utilizing patient advocates in Parkinson's disease: A proposed framework for patient engagement and the modern metrics that can determine its success', Health Expectations, 23(4), pp. 722-730. doi: https://doi.org/10.1111/hex.13064. Getz, K. (2019) ‘Reflections on the Evolution of Patient Engagement in Drug Development', Pharmaceutical Medicine, 33(3), pp. 179-185. doi: 10.1007/s40290 019-00284-1.

Gibson, A. et al. (2019) ‘Challenges and opportunities for involving patients and the public in acute antimicrobial medicine development research: an interview study', BMJ Open, 9(4), p. e024918. doi: 10.1136/bmjopen-2018-024918.

Haerry, D. et al. (2018) ‘EUPATI and Patients in Medicines Research and Development: Guidance for Patient Involvement in Regulatory Processes', Frontiers in Medicine. Frontiers, 5. doi: 10.3389/fmed.2018.00230.

Hansen, M. B., Nørgaard, L. S. and Hallgreen, C. E. (2019) ‘How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations', Therapeutic Innovation & Regulatory Science, p. 216847901986429. doi: 10.1177/2168479019864294.

Hoos, A. et al. (2015) ‘Partnering With Patients in the Development and Lifecycle of Medicines', Therapeutic Innovation & Regulatory Science, 49(6), pp. 929-939. doi: 10.1177/2168479015580384.

Lansdowne, L. E. (2020) Exploring the Drug Development Process, Drug Discovery from Technology Networks. Available at: https://www.technologynetworks.com/drug-discovery/articles/exploring-the-drugdevelopment-process-331894 (Accessed: 29 May 2021).

Levitan, B. et al. (2018) ‘Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project', Therapeutic Innovation & Regulatory Science. SAGE Publications Inc, 52(2), pp. 220- 229. doi: 10.1177/2168479017716715.

Lowe, M. M. et al. (2016) ‘Increasing Patient Involvement in Drug Development', Value in Health, 19(6), pp. 869-878. doi: 10.1016/j.jval.2016.04.009.

Matej Mikulic (2020) Global pharmaceutical industry - statistics & facts | Statista. Available at: https://www.statista.com/topics/1764/global-pharmaceuticalindustry/#dossierSummary (Accessed: 9 May 2021).

Ocloo, J. et al. (2021) ‘Exploring the theory, barriers and enablers for patient and public involvement across health, social care and patient safety: a systematic review of reviews', Health Research Policy and Systems, 19(1), p. 8. doi: 10.1186/s12961 020-00644-3.

Patient Group Engagement (2016) Clinical Trials Transformation Initiative. Available at: https://www.ctti-clinicaltrials.org/projects/patient-groups-clinical-trials (Accessed: 10 May 2021). Peña, O. I. G., Zavala, M. Á. L. and Ruelas, H. C. (2021) ‘Pharmaceuticals Market, Consumption Trends and Disease Incidence Are Not Driving the Pharmaceutical Research on Water and Wastewater', International Journal of Environmental Research and Public Health, 18(5), p. 2532. doi: 10.3390/ijerph18052532.

du Plessis, D. et al. (2017) ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?', Therapeutic Innovation & Regulatory Science. SAGE Publications Inc, 51(4), pp. 460-467. doi: 10.1177/2168479017696268.

PWC (2020) ‘From vision to decision Pharma 2020'.

Sacristán, J. A. et al. (2016) ‘Patient involvement in clinical research: why, when, and how', Patient preference and adherence, 10, pp. 631-640. doi: 10.2147/PPA.S104259.

Schilling, I. et al. (2019) ‘Patient involvement in clinical trials: motivation and expectations differ between patients and researchers involved in a trial on urinary tract infections', Research Involvement and Engagement, 5(1), p. 15. doi: 10.1186/s40900-019-0145-3.

Schultz-Knudsen, K. et al. (2021) ‘New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels', Therapeutic Innovation & Regulatory Science, 55(3), pp. 503-513. doi: 10.1007/s43441-020-00244-x.

Teramae, F. et al. (2020) ‘Impact of Research and Development Strategy on Sustainable Growth in Multinational Pharmaceutical Companies', Sustainability, 12(13), p. 5358. doi: 10.3390/su12135358.

Wale, J. L. et al. (2021) ‘Patients and public are important stakeholders in health technology assessment but the level of involvement is low - a call to action', Research Involvement and Engagement, 7(1), p. 1. doi: 10.1186/s40900-020-00248 9. APPENDICES
citation:   Roy, Ria Rose  (2021) Barriers that Restrict Patient Involvement in Drug Development: An Industrial Perspective.  Masters thesis, Innopharma.   
document_url: http://go.griffith.ie/504/1/10346_Ria_Rose_Roy_Dissertation_148436_15219086.pdf
document_url: http://go.griffith.ie/504/2/bibliography.txt