Clinical trials impacted by the COVID-19 pandemic: Adaptive designs to the rescue?
| Autor: | Kelly Van Lancker, Silke Jörgens, Christoph Gerlinger, Frank Bretz, Dong Xi, Tim Friede, Nigel Stallard, Sarah Zohar, Cornelia Ursula Kunz |
|---|---|
| Přispěvatelé: | Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université de Paris (UP) |
| Rok vydání: | 2020 |
| Předmět: |
Statistics and Probability
Design modification FOS: Computer and information sciences medicine.medical_specialty 2019-20 coronavirus outbreak Coronavirus disease 2019 (COVID-19) Special Issue on COVID-19 [SDV]Life Sciences [q-bio] viruses Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Pharmaceutical Science Statistics - Applications 01 natural sciences World health 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine Pandemic medicine Applications (stat.AP) 030212 general & internal medicine [MATH]Mathematics [math] 0101 mathematics Intensive care medicine ComputingMilieux_MISCELLANEOUS SARS-CoV-2 business.industry QH Design changes virus diseases R1 QR 3. Good health Clinical trial Interim analysis Heterogeneity business RA Research Article |
| Zdroj: | Statistics in Biopharmaceutical Research Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.461-477. ⟨10.1080/19466315.2020.1799857⟩ article-version (VoR) Version of Record |
| ISSN: | 1946-6315 |
| DOI: | 10.48550/arxiv.2005.13979 |
| Popis: | Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic by the World Health Organization. The pandemic has a number of consequences for the ongoing clinical trials in non-COVID-19 conditions. Motivated by four currently ongoing clinical trials in a variety of disease areas we illustrate the challenges faced by the pandemic and sketch out possible solutions including adaptive designs. Guidance is provided on (i) where blinded adaptations can help; (ii) how to achieve type I error rate control, if required; (iii) how to deal with potential treatment effect heterogeneity; (iv) how to utilize early readouts; and (v) how to utilize Bayesian techniques. In more detail approaches to resizing a trial affected by the pandemic are developed including considerations to stop a trial early, the use of group-sequential designs or sample size adjustment. All methods considered are implemented in a freely available R shiny app. Furthermore, regulatory and operational issues including the role of data monitoring committees are discussed. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|