Publikationen von Marta Bofill Roig
2024
- Nguyen Q.L., Hees K., Hernandez Penna S., König F., Posch M., Bofill Roig M., Meyer E.L., Freitag M.M., Parke T., Otte M., Dauben H.-P., Mielke T., Spiertz C., Mesenbrink P., Gidh-Jain M., Pierre S., Morello S., Hofner B.
Regulatory Issues of Platform Trials: Learnings from EU-PEARL.
Clinical Pharmacology and Therapeutics 116(1), 52–63, (2024) [bib]
@ARTICLE{nguyen2024ript5263, author = {Nguyen, Q.L.~ and Hees, K.~ and Hernandez Penna, S.~ and K{\"o}nig, F.~ and Posch, M.~ and Bofill Roig, M.~ and Meyer, E.L.~ and Freitag, M.M.~ and Parke, T.~ and Otte, M.~ and Dauben, H.-P.~ and Mielke, T.~ and Spiertz, C.~ and Mesenbrink, P.~ and Gidh-Jain, M.~ and Pierre, S.~ and Morello, S.~ and Hofner, B.~}, title = {Regulatory Issues of Platform Trials: Learnings from EU-PEARL.}, journal = {Clinical Pharmacology and Therapeutics}, year = {2024}, volume = {116}, number = {1}, pages = {52--63}, issn = {1532-6535 0009-9236}, doi = {10.1002/cpt.3244} } - Bofill Roig M., Glimm E., Mielke T., Posch M.
Optimal Allocation Strategies in Platform Trials with Continuous Endpoints.
Statistical Methods in Medical Research 33(5), 858–874, (2024) [bib]
@ARTICLE{bofillroig2024oasp858874, author = {Bofill Roig, M.~ and Glimm, E.~ and Mielke, T.~ and Posch, M.~}, title = {Optimal Allocation Strategies in Platform Trials with Continuous Endpoints.}, journal = {Statistical Methods in Medical Research}, year = {2024}, volume = {33}, number = {5}, pages = {858--874}, issn = {1477-0334 0962-2802}, doi = {10.1177/09622802241239008}, keywords = {Platform trial;optimal allocation;shared controls;time trends} } - Fischer L., Bofill Roig M., Brannath W.
The Online Closure Principle.
Annals of Statistics 52(2), 817–841, (2024) [bib]
@ARTICLE{fischer2024ocp817841, author = {Fischer, L.~ and Bofill Roig, M.~ and Brannath, W.~}, title = {The Online Closure Principle.}, journal = {Annals of Statistics}, year = {2024}, volume = {52}, number = {2}, pages = {817--841}, doi = {10.1214/24-AOS2370}, url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85193821836\&doi=10.1214%2f24-AOS2370\&partnerID=40\&md5=1e7c577e8c4220096e830c88eeb2d8bf} } - Balcar L., Scheiner B., Fulgenzi C.A.M., D´Alessio A., Pomej K., Bofill Roig M., Meyer E.L., Che J., Nishida N., Lee P.-C., Wu L., Ang C., Krall A., Saeed A., Stefanini B., Cammarota A., Pressiani T., Abugabal Y.I., Chamseddine S., Wietharn B., Parisi A., Huang Y.-H., Phen S., Vivaldi C., Salani F., Masi G., Bettinger D., Vogel A., von Felden J., Schulze K., Silletta M., Trauner M., Samson A., Wege H., Piscaglia F., Galle P.R., Stauber R., Kudo M., Singal A.G., Itani A., Ulahannan S.V., Parikh N.D., Cortellini A., Kaseb A., Rimassa L., Chon H.J., Pinato D.J., Pinter M.
A Meta-Analysis and Real-World Cohort Study on the Sex-Related Differences in Efficacy and Safety of Immunotherapy for Hepatocellular Carcinoma.
JHEP Reports 6(2):100982, (2024) [bib]
@ARTICLE{balcar2024amrc100982, author = {Balcar, L.~ and Scheiner, B.~ and Fulgenzi, C.A.M.~ and D´Alessio, A.~ and Pomej, K.~ and Bofill Roig, M.~ and Meyer, E.L.~ and Che, J.~ and Nishida, N.~ and Lee, P.-C.~ and Wu, L.~ and Ang, C.~ and Krall, A.~ and Saeed, A.~ and Stefanini, B.~ and Cammarota, A.~ and Pressiani, T.~ and Abugabal, Y.I.~ and Chamseddine, S.~ and Wietharn, B.~ and Parisi, A.~ and Huang, Y.-H.~ and Phen, S.~ and Vivaldi, C.~ and Salani, F.~ and Masi, G.~ and Bettinger, D.~ and Vogel, A.~ and von Felden, J.~ and Schulze, K.~ and Silletta, M.~ and Trauner, M.~ and Samson, A.~ and Wege, H.~ and Piscaglia, F.~ and Galle, P.R.~ and Stauber, R.~ and Kudo, M.~ and Singal, A.G.~ and Itani, A.~ and Ulahannan, S.V.~ and Parikh, N.D.~ and Cortellini, A.~ and Kaseb, A.~ and Rimassa, L.~ and Chon, H.J.~ and Pinato, D.J.~ and Pinter, M.~}, title = {A Meta-Analysis and Real-World Cohort Study on the Sex-Related Differences in Efficacy and Safety of Immunotherapy for Hepatocellular Carcinoma.}, journal = {JHEP Reports}, year = {2024}, volume = {6}, number = {2}, pages = {100982}, doi = {10.1016/j.jhepr.2023.100982}, url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85181836366\&doi=10.1016%2fj.jhepr.2023.100982\&partnerID=40\&md5=b6153f6e1dd382e0671bf8c7d66a6068} } - Bofill Roig M., Gómez Melis G., Posch M., Koenig F.
Adaptive Clinical Trial Designs with Blinded Selection of Binary Composite Endpoints and Sample Size Reassessment.
Biostatistics 25(1), 237–252, (2024) [bib]
@ARTICLE{bofillroig2024actd237252, author = {Bofill Roig, M.~ and Gómez Melis, G.~ and Posch, M.~ and Koenig, F.~}, title = {Adaptive Clinical Trial Designs with Blinded Selection of Binary Composite Endpoints and Sample Size Reassessment.}, journal = {Biostatistics}, year = {2024}, volume = {25}, number = {1}, pages = {237--252}, issn = {1468-4357 1465-4644}, doi = {10.1093/biostatistics/kxac040}, keywords = {Adaptive design;Interim analysis;Clinical trial;Composite endpoint;Sample size} }
2023
- Semmler G., Scheiner B., Balcar L., Paternostro R., Simbrunner B., Pinter M., Trauner M., Bofill Roig M., Meyer E.L., Hofer B.S., Mandorfer M., Pinato D.J., Zauner C., Reiberger T., Funk G.-C.
Disturbances in Sodium and Chloride Homeostasis Predict Outcome in Stable and Critically Ill Patients with Cirrhosis.
Alimentary Pharmacology & Therapeutics 58(1), 71–79, (2023) [bib]
@ARTICLE{semmler2023dsch7179, author = {Semmler, G.~ and Scheiner, B.~ and Balcar, L.~ and Paternostro, R.~ and Simbrunner, B.~ and Pinter, M.~ and Trauner, M.~ and Bofill Roig, M.~ and Meyer, E.L.~ and Hofer, B.S.~ and Mandorfer, M.~ and Pinato, D.J.~ and Zauner, C.~ and Reiberger, T.~ and Funk, G.-C.~}, title = {Disturbances in Sodium and Chloride Homeostasis Predict Outcome in Stable and Critically Ill Patients with Cirrhosis.}, journal = {Alimentary Pharmacology \& Therapeutics}, year = {2023}, volume = {58}, number = {1}, pages = {71--79}, doi = {10.1111/apt.17507} } - Krotka P., Hees K., Jacko P., Magirr D., Posch M., Bofill Roig M.
NCC: An R-Package for Analysis and Simulation of Platform Trials with Non-Concurrent Controls.
SoftwareX 23:101437, (2023) [bib]
@ARTICLE{krotka2023nras101437, author = {Krotka, P.~ and Hees, K.~ and Jacko, P.~ and Magirr, D.~ and Posch, M.~ and Bofill Roig, M.~}, title = {NCC: An R-Package for Analysis and Simulation of Platform Trials with Non-Concurrent Controls.}, journal = {SoftwareX}, year = {2023}, volume = {23}, pages = {101437}, issn = {2352-7110}, doi = {10.1016/j.softx.2023.101437}, url = {https://www.sciencedirect.com/science/article/pii/S2352711023001334}, keywords = {Non-concurrent controls;Platform trials;Clinical trial simulation;Shared controls;Statistics} } - Bofill Roig M., Burgwinkel C., Garczarek U., Koenig F., Posch M., Nguyen Q., Hees K.
On the Use of Non-Concurrent Controls in Platform Trials: A Scoping Review.
Trials 24:408, (2023) [bib]
@ARTICLE{bofillroig2023uncp408, author = {Bofill Roig, M.~ and Burgwinkel, C.~ and Garczarek, U.~ and Koenig, F.~ and Posch, M.~ and Nguyen, Q.~ and Hees, K.~}, title = {On the Use of Non-Concurrent Controls in Platform Trials: A Scoping Review.}, journal = {Trials}, year = {2023}, volume = {24}, pages = {408}, issn = {1745-6215}, doi = {10.1186/s13063-023-07398-7}, keywords = {Humans;Bias;Randomized Controlled Trials as Topic;*Bayes Theorem;Non-concurrent controls;Platform trials;External controls} }
2022
- Bofill Roig M., König F., Meyer E., Posch M.
Commentary: Two Approaches to Analyze Platform Trials Incorporating Non-Concurrent Controls with a Common Assumption.
Clinical Trials 19(5), 502–503, (2022) [bib]
@ARTICLE{bofillroig2022ctat502503, author = {Bofill Roig, M.~ and K{\"o}nig, F.~ and Meyer, E.~ and Posch, M.~}, title = {Commentary: Two Approaches to Analyze Platform Trials Incorporating Non-Concurrent Controls with a Common Assumption.}, journal = {Clinical Trials}, year = {2022}, volume = {19}, number = {5}, pages = {502--503}, issn = {1740-7753 1740-7745}, doi = {10.1177/17407745221112016} } - Bofill Roig M., Krotka P., Burman C.-F., Glimm E., Gold S.M., Hees K., Jacko P., Koenig F., Magirr D., Mesenbrink P., Viele K., Posch M.
On Model-Based Time Trend Adjustments in Platform Trials with Non-Concurrent Controls.
BMC Medical Research Methodology 22:228, (2022) [bib]
@ARTICLE{bofillroig2022mtta228, author = {Bofill Roig, M.~ and Krotka, P.~ and Burman, C.-F.~ and Glimm, E.~ and Gold, S.M.~ and Hees, K.~ and Jacko, P.~ and Koenig, F.~ and Magirr, D.~ and Mesenbrink, P.~ and Viele, K.~ and Posch, M.~}, title = {On Model-Based Time Trend Adjustments in Platform Trials with Non-Concurrent Controls.}, journal = {BMC Medical Research Methodology}, year = {2022}, volume = {22}, pages = {228}, issn = {1471-2288}, doi = {10.1186/s12874-022-01683-w}, keywords = {Humans;Bias;*Sample Size;Adding arms;Non-concurrent controls;Platform trials} } - Bofill Roig M., Gómez Melis G.
A Class of Two-Sample Nonparametric Statistics for Binary and Time-to-Event Outcomes.
Statistical Methods in Medical Research 31(2), 225–239, (2022) [bib]
@ARTICLE{bofillroig2022actn225239, author = {Bofill Roig, M.~ and Gómez Melis, G.~}, title = {A Class of Two-Sample Nonparametric Statistics for Binary and Time-to-Event Outcomes.}, journal = {Statistical Methods in Medical Research}, year = {2022}, volume = {31}, number = {2}, pages = {225--239}, issn = {0962-2802}, doi = {10.1177/09622802211048030}, url = {https://doi.org/10.1177/09622802211048030} } - Gold S.M., Bofill Roig M., Miranda J.J., Pariante C., Posch M., Otte C.
Platform Trials and the Future of Evaluating Therapeutic Behavioural Interventions.
Nature Reviews Psychology 1, 7–8, (2022) [bib]
@ARTICLE{gold2022ptfe78, author = {Gold, S.M.~ and Bofill Roig, M.~ and Miranda, J.J.~ and Pariante, C.~ and Posch, M.~ and Otte, C.~}, title = {Platform Trials and the Future of Evaluating Therapeutic Behavioural Interventions.}, journal = {Nature Reviews Psychology}, year = {2022}, volume = {1}, pages = {7--8}, doi = {10.1038/s44159-021-00012-0}, url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85134244354\&doi=10.1038%2fs44159-021-00012-0\&partnerID=40\&md5=1d7085d8ae7146b83352659d4eb7ba82} }