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.
  • Full version

• 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. 
  • Full version
  • Study protocol
  • Open data

• 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. 
  • Full version
  • Study protocol
  • Open data

• Kimmelman J, Waligora M, Lynch HF. Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials-Reply. JAMA Pediatr. 2019;173(6):609-610. 
  • Full version

• Kimmelman J, Waligora M, Lynch HF. Participant Protection in Phase 1 Pediatric Cancer Trials. JAMA Pediatr. 2019;173(1):8-9. 
  • Full version

• 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. 
  • Full version

• 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. 
  • Full version
  • Study protocol
  • Open data

• 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. 
  • Full version

• 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. 
  • Full version

• Piasecki J, Waligora M, Dranseika V. Non-beneficial pediatric research: individual and social interests. Med Health Care Philos. 2015;18(1):103-112.
  • Full version

• Waligora M, Dranseika V, Piasecki J. Child’s assent in research: age threshold or personalisation?. BMC Med Ethics. 2014;15:44. 
  • Full version

• Waligora M. Is a requirement of personalised assent realistic? A case from the GABRIEL project.  Eur J Hum Genet. 2014;22(7):855. 
  • Full version

• 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, 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.

  • Full version
  • Study protocol
  • Open data

• 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.  

  • Full version
  • Study protocol
  • Open data

• Strzebonska K, Waligora M. Umbrella and basket trials in oncology: ethical challenges. BMC Med Ethics. 2019;23;20(1):58. 
  • Full version

• 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.
  • Full version

• 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. 
  • Full version
  • Study protocol

• 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. 
  • Full version

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.
  • Full version

• 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.
  • Full version
  • Open Data

• 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.
  • Full version
  • Preprint
  • Study protocol
  • Open Data

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. 
  • Full version
  • Study protocol
  • Open data

• 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. 
  • Full version

• 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. 
  • Full version

• Waligora M. A European consistency for functioning of RECs? We just lost our chance. J Med Ethics. 2013;39(6):408-409.
  • Full version

• Waligora M, Failures in clinical trials in the European Union: lessons from the Polish experience. Sci Eng Ethics. 2013;19(3):1087-1098. 
  • Full version

• Różyńska J, Waligóra M (eds.), Badania z udziałem ludzi w biomedycynie. Standardy międzynarodowe, Warszawa: Wolters Kluwer Polska 2012.
  • Full version

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. 
  • Full version

• Dranseika V, Piasecki J, Waligora M. Forensic uses of research biobanks: should donors be informed?. Med Health Care Philos. 2016;19(1):141-146. 
  • Full version