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• W3014020776 abstract "Understanding, and adequately articulating how and what the patient feels and experiencesduring the progression of a disease and during drug treatment is an important aspect in apatient’s life. Yet this articulation does not always get appropriate attention and thus thepatient experience may not be fully understood by others. Nor is it fully explored in drugdevelopment programs due to the lack of focus on patient outcomes. Drug developmenthas in the past primarily focused on meeting the regulatory approval of the new drug. Togain regulatory approval a company has to provide evidence of the drug’s safety, andefficacy, combined with a favourable benefit-risk ratio. The patient benefits or patientconcerns, especially in the case of cancer, is thus often masked within the clinical endpoints,such as overall survival or progression free survival, or if patient outcomes are measured,they may not be appropriately articulated in dialog between stakeholders, or inpublications.Recent years have seen an upswing in pharmaceutical companies introducing a so-calledpatient-centric research and focus is shifting towards patient relevant endpoints. However,pharmaceutical companies do not always fully understand how such patient-centricresearch is to be conducted, and if data is collected, how to interpret the data and how topresent the data to stakeholders. The two most important pharmaceutical drug regulatorsand approval bodies, at least in terms of millions of lives they potentially affect, theEuropean Medicines Agency (EMA) and the Food and Drug Administration (FDA) have bothin the recent years embraced the concept of patient-centricity, and patient experience intheir guidance to the industry. There is an increased acceptance of this type of evidence inregulatory submissions, thus, opening opportunities for pharma companies to promoteresearch towards patient relevant endpoints and evidence.It is with this background that this thesis is written and compiled, with the aim of discussinghow Patient Reported Outcomes (PRO) research can, and should be integrated intopharmaceutical drug development, and how such results can be presented, while keeping inmind the many different stakeholders that need this information, ranging from regulatoryagencies, to payers, physicians and patients. The thesis makes use of eight recent patientcentredpapers published in the field of prostate cancer.The papers and the research make a number of important contributions by providingexamples of different approaches on how the PRO analyses are conducted, exploringdifferent way of reporting results and by linking the results of PRO evidence to clinicaloutcomes. Through the iterative learning process, which came as a result of the research Iconducted over time and by exploring different analyses methods, ways of presentingresults and presenting results to different journals, I learnt how to conduct this type ofresearch, all the way from conceptualization, through data collection, analyses andreporting of results. Thus by combining this learning, which was gained from this research,with the papers selected for this thesis, this has provided me with the structure and learningand legacy that I can bring forward from this research. It provides the basis for the constructof the framework presented in this thesis for how such Outcomes Research can beimplemented in drug development. This blueprint and framework can be adapted to anydisease area and can enhance the impact of the research, enhance new drug treatments,and help patient’s get the best and most suited treatment options.As an overall mantra of clinical drug development, we must embrace that the ultimateraison d’etre of any medicine or intervention, must be to the benefit of the patients and toimprove their health." @default.
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• W3014020776 date "2019-01-01" @default.
• W3014020776 modified "2023-09-22" @default.
• W3014020776 title "Integration of Patient Reported Outcomes in Pharmaceutical Drug Development For Prostate Cancer – Focus on the Patient" @default.
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