PEDIATRIC RESEARCH

• Bicer S, Hutchinson N, Feldhake E, Nelson A, Oliviero E, Waligóra M, Kimmelman J. Timing for First-in-Minor Clinical Trials of New Cancer Drugs. J Pediatr. 2023 Aug 30:113705.
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• Strzebonska K, Wasylewski MT, Zaborowska L, Polak M, Slugocka E, Stras J, Blukacz M, Gyawali B, Waligora M. Risk and Benefit for Targeted Therapy Agents in Pediatric Phase II Trials in Oncology: A Systematic Review with a Meta-Analysis. Target Oncol. 2021;16(4):415-424. 
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• Wasylewski MT, Strzebonska K, Koperny M, Polak M, Kimmelman J, Waligora M. Clinical development success rates and social value of pediatric Phase 1 trials in oncology. PLoS One. 2020;15(6):e0234911. 
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• Kimmelman J, Waligora M, Lynch HF. Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials-Reply. JAMA Pediatr. 2019;173(6):609-610. 
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• Kimmelman J, Waligora M, Lynch HF. Participant Protection in Phase 1 Pediatric Cancer Trials. JAMA Pediatr. 2019;173(1):8-9. 
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• Waligora M, Strzebonska K, Wasylewski MT. Neither the Harm Principle nor the Best Interest Standard Should Be Applied to Pediatric Research. Am J Bioeth. 2018;18(8):72-74. 
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• Waligora M, Bala MM, Koperny M, Wasylewski MT, Strzebonska K, Jaeschke RR, Wozniak A, Piasecki J, Sliwka A, Mitus JW, Polak M, Nowis D, Fergusson D, Kimmelman J, Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis. PLoS Med. 2018;15(2):e1002505. 
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• Piasecki J, Waligora M, Dranseika V, Assent in Paediatric Research and Its Consequences. In: Strech D., Mertz M. (eds) Ethics and Governance of Biomedical Research. Research Ethics Forum, vol 4. Springer, Cham. 2016. 
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• Waligora M, Różyńska J, Piasecki J. Child’s objection to non-beneficial research: capacity and distress based models. Med Health Care Philos. 2016;19(1):65-70. 
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• Piasecki J, Waligora M, Dranseika V. Non-beneficial pediatric research: individual and social interests. Med Health Care Philos. 2015;18(1):103-112.
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• Waligora M, Dranseika V, Piasecki J. Child’s assent in research: age threshold or personalisation?. BMC Med Ethics. 2014;15:44. 
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• Waligora M. Is a requirement of personalised assent realistic? A case from the GABRIEL project.  Eur J Hum Genet. 2014;22(7):855. 
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• Wasylewski M, Waligora M, Wybrane aspekty etyczne w genetyce pediatrycznej, in: R Śmigiel, K Szczałuba (eds.), Genetyczne uwarunkowane zaburzenia rozwoju u dzieci, Warszawa: PZWL 2021.

• Waligóra M, Prawo dziecka do odmowy udziału w eksperymencie medycznym, w: Hartman J, Waligóra M (red.), Etyczne aspekty decyzji medycznych, Warszawa: Wolters Kluwer 2011.

NOVEL TRIAL DESIGN AND CLINICAL ENDPOINTS

• Klas K, Strzebonska K, Buedo P, Włodarczyk A, Gordon S, Kaszuba P, Polak M, Waligora M. Seamless trials in oncology: A cross-sectional analysis of characteristics and reporting. PLoS One. 2024 Dec 3;19(12):e0312797. doi: 10.1371/journal.pone.0312797. 

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• Klas K, Strzebonska K, Zaborowska L, Krawczyk T, Włodarczyk A, Bąk-Kuchejda U, Polak M, Van Wambeke S, Waligora M: Risk and Benefit for Basket Trials in Oncology: A Systematic Review and Meta-Analysis. Targeted Oncology 2024.

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• Strzebonska K, Blukacz M, Wasylewski MT, Polak M, Gyawali B, Waligora M. Risk and benefit for umbrella trials in oncology: a systematic review and meta-analysis. BMC Med. 2022; 20:219.  

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• Strzebonska K, Waligora M. Umbrella and basket trials in oncology: ethical challenges. BMC Med Ethics. 2019;23;20(1):58. 
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• Waligora, M., and Strzebonska, K. Umbrella trials design. In B. Frey (Ed.), The SAGE encyclopedia of research design 2022(1):1763-1764. SAGE Publications, Inc.
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• Kovic B, Jin X, Kennedy SA, Hylands M, Pedziwiatr M, Kuriyama A, Gomaa H, Lee Y, Katsura M, Tada M, Hong BY, Cho SM, Hong PJ, Yu AM, Sivji Y, Toma A, Xie L, Tsoi L, Waligora M, Prasad M, Bhatnagar N, Thabane L, Brundage M, Guyatt G, Xie F. Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology: A Systematic Review and Quantitative Analysis. JAMA Intern Med. 2018;1;178(12):1586-1596. 
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• Zhang Y, Morgan RL, Alonso-Coello P, Wiercioch W, Bała MM, Jaeschke RR, Styczeń K, Pardo-Hernandez H, Selva A, Ara Begum H, Morgano GP, Waligóra M, Agarwal A, Ventresca M, Strzebońska K, Wasylewski MT, Blanco-Silvente L, Kerth JL, Wang M, Zhang Y, Narsingam S, Fei Y, Guyatt G, Schünemann HJ. A systematic review of how patients value COPD outcomes. Eur Respir J. 2018;19;52(1):1800222. 
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ETHICS OF CLINICAL TRIALS DURING THE COVID-19

• Klas K, Strzebonska K, Waligora M. Ethical challenges of clinical trials with a repurposed drug in outbreaks. Medicine, Health Care and Philosophy. 2023.
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• Hutchinson N, Klas K, Carlisle BG, Polak M, Kimmelman J, Waligora M. Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis. BMC Research Notes. 2022;15(1):368.
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• Hutchinson N, Klas K, Carlisle BG, Kimmelman J, Waligora M. How informative were early SARS-CoV-2 treatment and prevention trials? A longitudinal cohort analysis of trials registered on ClinicalTrials.gov. PLoS One. 2022 Jan 21;17(1):e0262114.
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RESEARCH IN CENTRAL AND EASTERN EUROPE

• Strzebonska K, Wasylewski MT, Zaborowska L, Riedel N, Wieschowski S, Strech D,4, Waligora M. Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis. BMJ Open. 2020;10(1):e034666. 
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• Dranseika V, Gefenas E, Waligora M. Broadening the „Infrastructure Effect”: Lessons from the Early Development of Research Ethics in Eastern Europe. Am J Bioeth. 2016;16(6):26-28. 
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• Broga M, Mijaljica G, Waligora M, Keis A, Marusic A. Publication ethics in biomedical journals from countries in Central and Eastern Europe. Sci Eng Ethics. 2014;20(1):99-109. 
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• Waligora M. A European consistency for functioning of RECs? We just lost our chance. J Med Ethics. 2013;39(6):408-409.
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• Waligora M, Failures in clinical trials in the European Union: lessons from the Polish experience. Sci Eng Ethics. 2013;19(3):1087-1098. 
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• Różyńska J, Waligóra M (eds.), Badania z udziałem ludzi w biomedycynie. Standardy międzynarodowe, Warszawa: Wolters Kluwer Polska 2012.
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INFORMED CONSENT

• Dranseika V, Piasecki J, Waligora M. Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure. Sci Eng Ethics. 2017;23(1):215-225. 
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• Dranseika V, Piasecki J, Waligora M. Forensic uses of research biobanks: should donors be informed?. Med Health Care Philos. 2016;19(1):141-146. 
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