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5. Correction: Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing

Author

Law, Martin, Couturier, Dominique-Laurent, Choodari-Oskooei, Babak, Crout, Phillip, Gamble, Carrol, Jacko, Peter, Pallmann, Philip, Pilling, Mark, Robertson, David S., Robling, Michael, Sydes, Matthew R., Villar, Sofía S., Wason, James, Wheeler, Graham, Williamson, S. Faye, Yap, Christina, and Jaki, Thomas

Published
2023
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6. Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing

Author

Law, Martin, Couturier, Dominique-Laurent, Choodari-Oskooei, Babak, Crout, Phillip, Gamble, Carrol, Jacko, Peter, Pallmann, Philip, Pilling, Mark, Robertson, David S., Robling, Michael, Sydes, Matthew R., Villar, Sofía S., Wason, James, Wheeler, Graham, Williamson, S. Faye, Yap, Christina, and Jaki, Thomas

Published
2023
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8. A novel nano-iron supplement versus standard treatment for iron deficiency anaemia in children 6–35 months (IHAT-GUT trial): a double-blind, randomised, placebo-controlled non-inferiority phase II trial in The Gambia

Author

Mohammed, Nuredin I., Wason, James, Mendy, Thomas, Nass, Stefan A., Ofordile, Ogochukwu, Camara, Famalang, Baldeh, Bakary, Sanyang, Chilel, Jallow, Amadou T., Hossain, Ilias, Faria, Nuno, Powell, Jonathan J., Prentice, Andrew M., and Pereira, Dora I.A.

Published
2023
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10. Greater Transplant-Free Survival in Patients Receiving Obeticholic Acid for Primary Biliary Cholangitis in a Clinical Trial Setting Compared to Real-World External Controls

Author

Sturgess, Richard, Healey, Christopher, Gunasekera, Anton, Kallis, Yiannis, Wright, Gavin, Mathialahan, Thiriloganathan, Evans, Richard, Gasem, Jaber, Ramanaden, David, Ward, Emma, Bhalme, Mahesh, Southern, Paul, Maggs, James, Yousif, Mohamed, Mells, George, Srivastava, Brijesh, Foxton, Matthew, Collins, Carole, Prasad, Yash, Porras-Perez, Francisco, Yapp, Tom, Patel, Minesh, Ede, Roland, Carte, Martyn, Koss, Konrad, Sattianayagam, Prayman, Grimley, Charles, Tidbury, Jude, Mansour, Dina, Beckley, Matilda, Hollywood, Coral, Ramag, John, Gordon, Harriet, Ridpath, Joanne, Grover, Bob, Abouda, George, Rees, Ian, Narain, Mark, Salam, Imroz, Banim, Paul, Das, Debasish, Matthews, Helen, Mohammed, Faiyaz, Jones, Rebecca, Sen, Sambit, Bird, George, Prince, Martin, Prasad, Geeta, Kitchen, Paul, Hutchinson, John, Gupta, Prakash, Jones, David, Shah, Amir, Saha, Subrata, Pollock, Katharine, Barclay, Stephen, McDonald, Natasha, Rushbrook, Simon, Przemioslo, Robert, Millar, Andrew, Mitchell, Steven, Davis, Andrew, Naqvi, Asifabbas, Lee, Tom, Ryder, Stephen, Collier, Jane, Cramp, Matthew, Aspinal, Richard, Booth, Jonathan, Williams, Earl, Hussaini, Hyder, Christie, John, Chaudhry, Tehreem, Thorburn, Douglas, Mann, Stephen, Ala, Aftab, Maltby, Julia, Corbett, Chris, Singhal, Saket, Hoeroldt, Barbara, Butterworth, Jeff, Douglas, Andrew, Sinha, Rohit, Panter, Simon, Shearman, Jeremy, Bray, Gary, Roberts, Michael, Forton, Daniel, Taylor, Nicola, Jafar, Wisam, Cowan, Matthew, Ch'ng, Chin Lye, Rahman, Mesbah, Wesley, Emma, Jain, Sanjiv, Mandal, Aditya, Wright, Mark, Trivedi, Palak, Gordon, Fiona, Unitt, Esther, Austin, Andrew, Palegwala, Altaf, Vemala, Vishwaraj, Higham, Andrew, Fraser, Jocelyn, Li, Andy, Ramakrishnan, Subramaniam, King, Alistair, Whalley, Simon, Gee, Ian, Keld, Richard, Fellows, Helen, Gotto, James, Millson, Charles, Murillo Perez, C. Fiorella, Fisher, Holly, Hiu, Shaun, Kareithi, Dorcas, Adekunle, Femi, Mayne, Tracy, Malecha, Elizabeth, Ness, Erik, van der Meer, Adriaan J., Lammers, Willem J., Trivedi, Palak J., Battezzati, Pier Maria, Nevens, Frederik, Kowdley, Kris V., Bruns, Tony, Cazzagon, Nora, Floreani, Annarosa, Mason, Andrew L., Parés, Albert, Londoño, Maria-Carlota, Invernizzi, Pietro, Carbone, Marco, Lleo, Ana, Mayo, Marlyn J., Dalekos, George N., Gatselis, Nikolaos K., Verhelst, Xavier, Gulamhusein, Aliya, Janssen, Harry L.A., Smith, Rachel, Flack, Steve, Mulcahy, Victoria, Trauner, Michael, Bowlus, Christopher L., Lindor, Keith D., Corpechot, Christophe, Hirschfield, Gideon M., Wason, James, and Hansen, Bettina E.

Published
2022
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13. A hybrid approach to sample size re‐estimation in cluster randomized trials with continuous outcomes.

Author

Sarkodie, Samuel K, Wason, James MS, and Grayling, Michael J

Subjects
*CLUSTER randomized controlled trials, *HYBRID power, *SAMPLE size (Statistics)
Abstract

This study presents a hybrid (Bayesian‐frequentist) approach to sample size re‐estimation (SSRE) for cluster randomised trials with continuous outcome data, allowing for uncertainty in the intra‐cluster correlation (ICC). In the hybrid framework, pre‐trial knowledge about the ICC is captured by placing a Truncated Normal prior on it, which is then updated at an interim analysis using the study data, and used in expected power control. On average, both the hybrid and frequentist approaches mitigate against the implications of misspecifying the ICC at the trial's design stage. In addition, both frameworks lead to SSRE designs with approximate control of the type I error‐rate at the desired level. It is clearly demonstrated how the hybrid approach is able to reduce the high variability in the re‐estimated sample size observed within the frequentist framework, based on the informativeness of the prior. However, misspecification of a highly informative prior can cause significant power loss. In conclusion, a hybrid approach could offer advantages to cluster randomised trials using SSRE. Specifically, when there is available data or expert opinion to help guide the choice of prior for the ICC, the hybrid approach can reduce the variance of the re‐estimated required sample size compared to a frequentist approach. As SSRE is unlikely to be employed when there is substantial amounts of such data available (ie, when a constructed prior is highly informative), the greatest utility of a hybrid approach to SSRE likely lies when there is low‐quality evidence available to guide the choice of prior. [ABSTRACT FROM AUTHOR]

Published
2024
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19. The Adaptive designs CONSORT Extension (ACE) statement : a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Author

ACE Consensus Group, Dimairo, Munyaradzi, Pallmann, Philip, Wason, James, Todd, Susan, Jaki, Thomas, Julious, Steven A, Mander, Adrian P, Weir, Christopher J, Koenig, Franz, Walton, Marc K, Nicholl, Jon P, Coates, Elizabeth, Biggs, Katie, Hamasaki, Toshimitsu, Proschan, Michael A, Scott, John A, Ando, Yuki, Hind, Daniel, and Altman, Douglas G

Published
2020

20. Imaging breast cancer using hyperpolarized carbon-13 MRI

Author

Gallagher, Ferdia A., Woitek, Ramona, McLean, Mary A., Gill, Andrew B., Garcia, Raquel Manzano, Provenzano, Elena, Riemer, Frank, Kaggie, Joshua, Chhabra, Anita, Ursprung, Stephan, Grist, James T., Daniels, Charlie J., Zaccagna, Fulvio, Laurent, Marie-Christine, Locke, Matthew, Hilborne, Sarah, Frary, Amy, Torheim, Turid, Boursnell, Chris, Schiller, Amy, Patterson, Ilse, Slough, Rhys, Carmo, Bruno, Kane, Justine, Biggs, Heather, Harrison, Emma, Deen, Surrin S., Patterson, Andrew, Lanz, Titus, Kingsbury, Zoya, Ross, Mark, Basu, Bristi, Baird, Richard, Lomas, David J., Sala, Evis, Wason, James, Rueda, Oscar M., Chin, Suet-Feung, Wilkinson, Ian B., Graves, Martin J., Abraham, Jean E., Gilbert, Fiona J., Caldas, Carlos, and Brindle, Kevin M.

Published
2020

23. The mediating role of reflective functioning and general psychopathology in the relationship between childhood conduct disorder and adult aggression among offenders.

Author

Yirmiya, Karen, Constantinou, Matthew, Simes, Elizabeth, Bateman, Anthony, Wason, James, Yakeley, Jessica, McMurran, Mary, Crawford, Mike, Frater, Alison, Moran, Paul, Barrett, Barbara, Cameron, Angus, Hoare, Zoe, Allison, Elizabeth, Pilling, Stephen, Butler, Stephen, and Fonagy, Peter

Subjects
SECONDARY analysis, RESEARCH funding, CRIMINALS, QUESTIONNAIRES, REFLECTION (Philosophy), BEHAVIOR disorders in children, AGGRESSION (Psychology), FACTOR analysis, PSYCHOSOCIAL functioning, PATHOLOGICAL psychology, ADULTS
Abstract

Background The nature of the pathway from conduct disorder (CD) in adolescence to antisocial behavior in adulthood has been debated and the role of certain mediators remains unclear. One perspective is that CD forms part of a general psychopathology dimension, playing a central role in the developmental trajectory. Impairment in reflective functioning (RF), i.e. the capacity to understand one's own and others' mental states, may relate to CD, psychopathology, and aggression. Here, we characterized the structure of psychopathology in adult male-offenders and its role, along with RF, in mediating the relationship between CD in their adolescence and current aggression. Methods A secondary analysis of pre-treatment data from 313 probation-supervised offenders was conducted, and measures of CD symptoms, general and specific psychopathology factors, RF, and aggression were evaluated through clinical interviews and questionnaires. Results Confirmatory factor analyses indicated that a bifactor model best fitted the sample's psychopathology structure, including a general psychopathology factor (p factor) and five specific factors: internalizing, disinhibition, detachment, antagonism, and psychoticism. The structure of RF was fitted to the data using a one-factor model. According to our mediation model, CD significantly predicted the p factor, which was positively linked to RF impairments, resulting in increased aggression. Conclusions These findings highlight the critical role of a transdiagnostic approach provided by RF and general psychopathology in explaining the link between CD and aggression. Furthermore, they underscore the potential utility of treatments focusing on RF, such as mentalization-based treatment, in mitigating aggression in offenders with diverse psychopathologies. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Multisystemic therapy versus management as usual in the treatment of adolescent antisocial behaviour (START): 5-year follow-up of a pragmatic, randomised, controlled, superiority trial

Author

Fonagy, Peter, Butler, Stephen, Cottrell, David, Scott, Stephen, Pilling, Stephen, Eisler, Ivan, Fuggle, Peter, Kraam, Abdullah, Byford, Sarah, Wason, James, Smith, Jonathan A, Anokhina, Alisa, Ellison, Rachel, Simes, Elizabeth, Ganguli, Poushali, Allison, Elizabeth, and Goodyer, Ian M

Published
2020
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27. The WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer – a study protocol

Author

Ursprung, Stephan, Mossop, Helen, Gallagher, Ferdia A., Sala, Evis, Skells, Richard, Sipple, Jamal A. N., Mitchell, Thomas J., Chhabra, Anita, Fife, Kate, Matakidou, Athena, Young, Gemma, Walker, Amanda, Thomas, Martin G., Ortuzar, Mireia Crispin, Sullivan, Mark, Protheroe, Andrew, Oades, Grenville, Venugopal, Balaji, Warren, Anne Y., Stone, John, Eisen, Tim, Wason, James, Welsh, Sarah J., and Stewart, Grant D.

Published
2021
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28. Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial

Author

Vergis, Nikhil, Phillips, Rachel, Cornelius, Victoria, Katsarou, Alexia, Youngstein, Taryn, Cook, Lucy, Willicombe, Michelle, Pilay, Clio, Shturova, Tina, Almonte, Melanie, Charania, Asad, Turner, Richard, Kon, Onn Min, Cooke, Graham, Thursz, Mark, Cherlin, Svetlana, Wason, James, Milojkovic, Dragana, Innes, Andew J., and Cooper, Nichola

Published
2021
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30. Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project

Author

Wilson, Nina, Biggs, Katie, Bowden, Sarah, Brown, Julia, Dimairo, Munyaradzi, Flight, Laura, Hall, Jamie, Hockaday, Anna, Jaki, Thomas, Lowe, Rachel, Murphy, Caroline, Pallmann, Philip, Pilling, Mark A., Snowdon, Claire, Sydes, Matthew R., Villar, Sofía S., Weir, Christopher J., Welburn, Jessica, Yap, Christina, Maier, Rebecca, Hancock, Helen, and Wason, James M. S.

Published
2021
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32. Using a prognostic medical device for early identification of pressure ulcers: protocol for study design.

Author

Keltie, Kim, Parker, Rosalyn, Dervin, Humayra, Pagnamenta, Fania, Milne, Jeanette, Belilios, Emma, Latimer, Lizzy, Wason, James, Ogundimu, Emmanuel, McParlin, Catherine, and Sims, Andrew

Subjects
BIOPHYSICS, SKIN care, RANDOMIZED controlled trials, EARLY diagnosis, MEDICAL needs assessment, PRESSURE ulcers, SCIENTIFIC apparatus & instruments
Abstract

Background: An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders. Aim: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues. Method: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials. Results: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered. Conclusion: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care. [ABSTRACT FROM AUTHOR]

Published
2024
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33. A Comparison of Randomization Methods for Multi-Arm Clinical Trials.

Author

Azher, Ruqayya A., Wason, James M. S., and Grayling, Michael J.

Subjects
*RANDOMIZATION (Statistics), *CLINICAL trials, *RANDOMIZED controlled trials, *BLOCK designs, *STATISTICAL power analysis, *ARM
Abstract

Randomized controlled trials are widely accepted as the best design for evaluating the efficacy of a treatment, due to the advantages of randomization. The objectives of randomization include removing bias in the assignment of treatments, balancing numbers allocated to arms, and balancing observed and unobserved covariates between arms. Different randomization procedures, each with varying properties of randomness and balance, are available and investigators must be careful to select one that will result in desirable properties. In this article, we use a simulation study, based on two real clinical trials, to empirically test several allocation procedures for multi-arm trials: simple randomization, permuted block randomization, stratified randomization with permuted blocks, urn design, block urn design, stratified block urn design, andminimization.We evaluate properties such as group size balance, covariate balance, loss of precision (i.e., increase in the variance of treatment effect estimates), and predictability of assignment. We also compare different definitions of statistical power relevant inmulti-arm trials:marginal, disjunctive, and conjunctive powers. Based on the simulation results, the considered randomization methods have very little impact on the resultant powers. Consistently strong performance was seen across the performance metrics for stratified block randomization and the stratified block urn design. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Mentalization for Offending Adult Males (MOAM): study protocol for a randomized controlled trial to evaluate mentalization-based treatment for antisocial personality disorder in male offenders on community probation

Author

Fonagy, Peter, Yakeley, Jessica, Gardner, Tessa, Simes, Elizabeth, McMurran, Mary, Moran, Paul, Crawford, Mike, Frater, Alison, Barrett, Barbara, Cameron, Angus, Wason, James, Pilling, Stephen, Butler, Stephen, and Bateman, Anthony

Published
2020
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42. Evaluating the impact of outcome delay on the efficiency of two-arm group-sequential trials

Author

Mukherjee, Aritra, Grayling, Michael J., and Wason, James M. S.

Subjects
Methodology (stat.ME), FOS: Computer and information sciences, Statistics - Other Statistics, Other Statistics (stat.OT), Applications (stat.AP), Statistics - Applications, Statistics - Methodology
Abstract

Adaptive designs(AD) are a broad class of trial designs that allow preplanned modifications based on patient data providing improved efficiency and flexibility. However, a delay in observing the primary outcome variable can harm this added efficiency. In this paper, we aim to ascertain the size of such outcome delay that results in the realised efficiency gains of ADs becoming negligible compared to classical fixed sample RCTs. We measure the impact of delay by developing formulae for the no. of overruns in 2 arm GSDs with normal data, assuming different recruitment models. The efficiency of a GSD is usually measured in terms of the expected sample size (ESS), with GSDs generally reducing the ESS compared to a standard RCT. Our formulae measures the efficiency gain from a GSD in terms of ESS reduction that is lost due to delay. We assess whether careful choice of design (e.g., altering the spacing of the IAs) can help recover the benefits of GSDs in presence of delay. We also analyse the efficiency of GSDs with respect to time to complete the trial. Comparing the expected efficiency gains, with and without consideration of delay, it is evident GSDs suffer considerable losses due to delay. Even a small delay can have a significant impact on the trial's efficiency. In contrast, even in the presence of substantial delay, a GSD will have a smaller expected time to trial completion in comparison to a simple RCT. Although the no. of stages have little influence on the efficiency losses, the timing of IAs can impact the efficiency of a GSDs with delay. Particularly, for unequally spaced IAs, pushing IAs towards latter end of the trial can be harmful for the design with delay.

Published
2023

45. Bayesian sample size determination in basket trials borrowing information between subsets.

Author

Zheng, Haiyan, Grayling, Michael J, Mozgunov, Pavel, Jaki, Thomas, and Wason, James M S

Subjects
SAMPLE size (Statistics), BASKETS, FEATURE selection
Abstract

Basket trials are increasingly used for the simultaneous evaluation of a new treatment in various patient subgroups under one overarching protocol. We propose a Bayesian approach to sample size determination in basket trials that permit borrowing of information between commensurate subsets. Specifically, we consider a randomized basket trial design where patients are randomly assigned to the new treatment or control within each trial subset ("subtrial" for short). Closed-form sample size formulae are derived to ensure that each subtrial has a specified chance of correctly deciding whether the new treatment is superior to or not better than the control by some clinically relevant difference. Given prespecified levels of pairwise (in)commensurability, the subtrial sample sizes are solved simultaneously. The proposed Bayesian approach resembles the frequentist formulation of the problem in yielding comparable sample sizes for circumstances of no borrowing. When borrowing is enabled between commensurate subtrials, a considerably smaller trial sample size is required compared to the widely implemented approach of no borrowing. We illustrate the use of our sample size formulae with two examples based on real basket trials. A comprehensive simulation study further shows that the proposed methodology can maintain the true positive and false positive rates at desired levels. [ABSTRACT FROM AUTHOR]

Published
2023
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50. Bayesian borrowing for basket trials with longitudinal outcomes.

Author

Whitehead, Lou E., Sailer, Oliver, Witham, Miles D., and Wason, James M. S.

Subjects
FALSE positive error, BASKETS, EXPERIMENTAL design
Abstract

Basket trials are a novel clinical trial design in which a single intervention is investigated in multiple patient subgroups, or "baskets." They offer the opportunity to share information between subgroups, potentially increasing power to detect treatment effects. Basket trials offer several advantages over running a series of separate trials, including reduced sample sizes, increased efficiency, and reduced costs. Primarily, basket trials have been undertaken in Phase II oncology settings, but could be a promising design in other areas where a shared underlying biological mechanism drives different diseases. One such area is chronic aging‐related diseases. However, trials in this area frequently have longitudinal outcomes, and therefore suitable methods are needed to share information in this setting. In this paper, we extend three Bayesian borrowing methods for a basket design with continuous longitudinal endpoints. We demonstrate our methods on a real‐world dataset and in a simulation study where the aim is to detect positive basketwise treatment effects. Methods are compared with standalone analysis of each basket without borrowing. Our results confirm that methods that share information can improve power to detect positive treatment effects and increase precision over independent analysis in many scenarios. In highly heterogeneous scenarios, there is a trade‐off between increased power and increased risk of type I errors. Our proposed methods for basket trials with continuous longitudinal outcomes aim to facilitate their applicability in the area of aging related diseases. Choice of method should be made based on trial priorities and the expected basketwise distribution of treatment effects. [ABSTRACT FROM AUTHOR]

Published
2023
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