Browsing Research publications by Author "Salek, Sam"
Now showing items 21-30 of 30
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Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial
Donhauser, Theresa; Apfelbacher, Christian; Kann, Gesina; Masur, Clarissa; Kamudoni, Paul; Salek, Sam; Abels, Christoph; Gabes, Michaela (2023-06-06)Background: The Hyperhidrosis Quality of Life Index (HidroQoL ©) is a well-developed and validated patient-reported outcome measure assessing the quality-of-life impacts in hyperhidrosis with 18 items. Our aim was to extend ... -
Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review
Chan, Stefanie Ho Yi; Khatib, Yasmin; Webley, Sherael; Layton, Deborah; Salek, Sam (2023-06-13)Introduction: In the last few decades, there has been a rapid development in cancer therapies and improved detection strategies, hence the death rates caused by cancer have decreased. However, it has been reported that ... -
Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward
Sithole, Tariro; Mahlangu, Gugu; Walker, Stuart; Salek, Sam (2022-04-25)Introduction: The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate ... -
Psychometric validation of the Pyruvate Kinase Deficiency Diary and Pyruvate Kinase Deficiency Impact Assessment in adults in the phase 3 ACTIVATE trial
Andrae, David A.; Grace, RF; Jewett, Adrian; Foster, Brandon; Klaassen, Robert J.; Salek, Sam; Li, Junlong; Tai, Feng; Boscoe, Audra N.; Zagadailov, Erin (2023-11-09)Background: Pyruvate kinase (PK) deficiency is a rare hereditary disorder characterized by chronic hemolytic anemia and serious sequalae which negatively affect patient quality of life. This study aimed to psychometrically ... -
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies
Bujar, M; McAuslane, N; Stuart, Walker; Salek, Sam (2020-03-01)Background:To evaluate the quality of the decision-making processes of pharmaceutical companies during medicines development for evidence generation to support reimbursement of new medicines and the appraisal recommendation ... -
Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward
Sithole, Tariro; Mahlangu, Gugu; Walker, Stuart; Salek, Sam (2022-04-25)Introduction: ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall ... -
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening
Mashingia, Jane; Ngum, Nancy; Ndomondo-Sigonda, Margareth; Kermad, Adem; Bujar, Magda; Salek, Sam; Walker, Stuart (2023-05-31)Background: Seven national medicines regulatory authorities in the East African Community (EAC) have embraced regulatory reliance, harmonization and work sharing through the EAC Medicines Regulatory Harmonization programme. ... -
The Reporting, Use, and Validity of Patient-Reported Outcomes in Multiple Myeloma in Clinical Trials: A Systematic Literature Review
Salek, Sam; Ionova, Tatiana; Oliva, Esther Natalie; Andreas, Marike; Skoetz, Nicole; Kreuzberger, Nina; Laane, Edward (2022-12-06)Background: Patient-reported outcomes (PROs) are becoming increasingly important in supporting clinical outcomes in clinical trials. In multiple myeloma (MM), PRO measurement is useful to reveal how treatment affects ... -
South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access
Keyter, Andrea; Salek, Sam; Danks, Lorraine; Nkambule, Portia; Semete-Makokotlela, Boitumelo; Walker, Stuart (2021-07-23)Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the ... -
The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis
Kamudoni, Paul; Amtmann, Dagmar; Johns, Jeffrey; Cook, Karon F.; Salem, Rana; Salek, Sam; Raab, Jana; Middleton, Rod; Repovic, Pavle; Alschuler, Kevin N.; von Geldern, Gloria; Wundes, Annette; Barrett, Amy; Olayinka-Amao, Oyebimpe; Henke, Christian (2022-06-01)Background A valid, sensitive patient-reported outcome (PRO) measure of physical function (PF) for people with multiple sclerosis (MS) would have substantial value in routine care and clinical research. We now describe ...