Research Design Service: West Midlands

Outputs

Clinical trials impacted by the COVID-19 pandemic: Adaptive designs to the rescue?

Cornelia Ursula Kunz, Silke Jörgens, Frank Bretz, Nigel Stallard, Kelly Van Lancker, Dong Xi, Sarah Zohar, Christoph Gerlinger & Tim Friede (2020) Clinical trials impacted by the COVID-19 pandemic: Adaptive designs to the rescue?, Statistics in Biopharmaceutical Research, DOI: 10.1080/19466315.2020.1799857


Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19

Nigel Stallard, Lisa Hampson, Norbert Benda, Werner Brannath, Thomas Burnett, Tim Friede, Peter K. Kimani, Franz Koenig, Johannes Krisam, Pavel Mozgunov, Martin Posch, James Wason, Gernot Wassmer, John Whitehead, S. Faye Williamson, Sarah Zohar & Thomas Jaki (2020) Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19, Statistics in Biopharmaceutical Research, DOI: 10.1080/19466315.2020.1790415


Should treatment effects be estimated in pilot and feasibility studies?

Julius Sim (2019). Should treatment effects be estimated in pilot and feasibility studies? Pilot and Feasibility Studies, 5, 107, DOI:10.1186/s40814-019-0493-7


Focus group methodology: some ethical challenges

Julius Sim & Jackie Waterfield (2019). Focus group methodology: some ethical challenges. Quality & Quantity, 53(6), 3003-3022. DOI:10.1007/s11135-019-00914-5


Outcome-adaptive randomization in clinical trials: issues of participant welfare and autonomy

Julius Sim (2019). Outcome-adaptive randomization in clinical trials: issues of participant welfare and autonomy. Theoretical Medicine and Bioethics, 40(2), 83-101. DOI:10.1007/s11017-019-09481-0


Can sample size in qualitative research be determined a priori?

Julius Sim, Benjamin Saunders, Jackie Waterfield & Tom Kingstone (2018) Can sample size in qualitative research be determined a priori? International Journal of Social Research Methodology, 21(5), 619-634. DOI:10.1080/13645579.2018.1454643


Saturation in qualitative research: exploring its conceptualization and operationalization

Benjamin Saunders, Julius Sim, Tom Kingstone, Shula Baker, Jackie Waterfield, Bernadette Bartlam, Heather Burroughs & Clare Jinks (2018) Saturation in qualitative research: exploring its conceptualization and operationalization. Quality & Quantity, 52(4), 1893-1907. DOI:10.1007/s11135-017-0574-8


The nature and ethics of natural experiments

Angus Dawson & Julius Sim (2015) The nature and ethics of natural experiments. Journal of Medical Ethics, 41(10), 848-853. DOI:10.1136/medethics-2014-102254


DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

Cook, J.A., Julious, S.A., Sones, W., Hampson, L.V., Hewitt, C., Berlin, J., Ashby, D., Emsley, R., Fergusson, D.A., Walters, S.J., Wilson, E., Maclennan, G., Stallard, N., Rothwell, J.C., Bland, M., Brown, L., Ramsay, C.R., Cook, A., Armstrong, D., Altman, D., Vale, L.  (2018) DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial.  British Medical Journal, 363, k3750. doi.org/10.1136/bmj.k3750


Distinctive aspects of consent in pilot and feasibility studies

Julius Sim (2021) Distinctive aspects of consent in pilot and feasibility studies. Journal of Evaluation in Clinical Practice 27(3): 657-664. DOI: 10.1111/jep.13556


Metasynthesis: issues of empirical and theoretical context

Julius Sim, Anne Marit Menshoel (2022) Metasynthesis: issues of empirical and theoretical context. Quality and Quantity DOI: 10.1007/s11135-022-01502-w


What do randomised trials tell us and could they tell us more? Looking within and beyond the study sample
 
Julius Sim, Gillian Lancaster, Martyn Lewis (2022) What do randomised trials tell us and could they tell us more? Looking within and beyond the study sample. In: Macdougall M (ed) Gold standard or unhealthy fixation? A medical educator’s guide to current thinking on the status of randomised controlled trials in clinical research. Springer, Cham (in press)