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https://www.arca.fiocruz.br/handle/icict/59878
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3100-12-31
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INVOLVING PATIENTS IN DRUG DEVELOPMENT FOR NEGLECTED TROPICAL DISEASES (NTDS): A QUALITATIVE STUDY EXPLORING AND INCORPORATING PREFERENCES OF PATIENTS WITH CUTANEOUS LEISHMANIASIS INTO TARGET PRODUCT PROFILE DEVELOPMENT.
target product profile
cutaneous leishmaniasis
neglected tropical diseases
patient involvement
patient consultation
Author
Affilliation
Centro Internacional de Entrenamiento de Investigaciones Médicas. Cali, Colombia
Medical University of Vienna. Department of Epidemiology. . Vienna, Switzerland
Drugs for Neglected Diseases Initiative.
Oswaldo Cruz Foundation. Instituto Rene Rachou. Belo Horizonte, MG, Brasil
Heidelberg University Hospital. Division of Infectious Disease and Tropical Medicine and German Centre for Infection Research. Heidelberg, Germain
Medical University of Vienna. Division of Infectious Diseases and Tropical Medicine. Vienna, Switzerland
Medical University of Vienna. Division of Infectious Diseases and Tropical Medicine. Vienna, Switzerland
Universidad de Antioquia. Program for the Study and Control of Tropical Diseases. Antioquia, Colômbia.
University of Southampton. School of Primary Care, Population Sciences and Medical Education. Southampton, UK
Medical University of Vienna. Institute of Specific Prophylaxis and Tropical Medicine. Vienna, Switzerland
University of Oxford. Nuffield Department of Medicine. Oxford, UK
Medical University of Vienna. Department of Epidemiology. . Vienna, Switzerland
Drugs for Neglected Diseases Initiative.
Oswaldo Cruz Foundation. Instituto Rene Rachou. Belo Horizonte, MG, Brasil
Heidelberg University Hospital. Division of Infectious Disease and Tropical Medicine and German Centre for Infection Research. Heidelberg, Germain
Medical University of Vienna. Division of Infectious Diseases and Tropical Medicine. Vienna, Switzerland
Medical University of Vienna. Division of Infectious Diseases and Tropical Medicine. Vienna, Switzerland
Universidad de Antioquia. Program for the Study and Control of Tropical Diseases. Antioquia, Colômbia.
University of Southampton. School of Primary Care, Population Sciences and Medical Education. Southampton, UK
Medical University of Vienna. Institute of Specific Prophylaxis and Tropical Medicine. Vienna, Switzerland
University of Oxford. Nuffield Department of Medicine. Oxford, UK
Abstract
Background: Target Product Profiles (TPPs) are instrumental to help optimise the design and development of therapeutics, vaccines, and diagnostics – these products, to achieve the intended impact, should be aligned with users’ preferences and needs. However, patients are rarely involved as key stakeholders in building a TPP.
Methods: Thirty-three cutaneous leishmaniasis (CL) patients from Brazil, Colombia, and Austria, infected with New-World Leishmania species, were recruited using a maximum variation approach along geographic, sociodemographic and clinical criteria. Semi-structured interviews were conducted in the patient’s mother tongue. Transcripts, translated into English, were analysed using a framework approach. We matched disease experiences, preferences, and expectations of CL patients to a TPP developed by DNDi (Drug for Neglected Diseases initiative) for CL treatment.
Findings: Patients’ preferences regarding treatments ranged from specific efficacy and safety endpoints to direct and significant indirect costs. Respondents expressed views about trade-offs between efficacy and experienced discomfort/adverse events caused by treatment. Reasons for non-compliance, such as adverse events or geographical and availability barriers, were discussed. Considerations related to accessibility and affordability were relevant from the patients’ perspective.
Interpretation: This exploratory study identified preferences in a broad international patient spectrum. It provides methodological guidance on how patients can be meaningfully involved as stakeholders in the construction of a TPP of therapeutics for NTDs. CL is used as exemplar, but the approach can be adapted for other NTDs.
Keywords
drug developmenttarget product profile
cutaneous leishmaniasis
neglected tropical diseases
patient involvement
patient consultation
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