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2. 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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3. 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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4. Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs

Author

Burnett, Thomas, Mozgunov, Pavel, Pallmann, Philip, Villar, Sofia S., Wheeler, Graham M., and Jaki, Thomas

Subjects
Statistics - Applications
Abstract

Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical and efficient. These benefits are achieved while preserving the integrity and validity of the trial, through the pre-specification and proper adjustment for the possible alterations during the course of the trial. Despite much research in the statistical literature highlighting the potential advantages of adaptive designs over traditional fixed designs, the uptake of such methods in clinical research has been slow. One major reason for this is that different adaptations to trial designs, as well as their advantages and limitations, remain unfamiliar to large parts of the clinical community. The aim of this paper is to clarify where adaptive designs can be used to address specific questions of scientific interest; we introduce the main features of adaptive designs and commonly used terminology, highlighting their utility and pitfalls, and illustrate their use through case studies of adaptive trials ranging from early-phase dose escalation to confirmatory Phase III studies., Comment: 35 pages, 9 figures

Published
2020

5. A review of available software for adaptive clinical trial design

Author

Grayling, Michael J and Wheeler, Graham M

Subjects
Statistics - Computation
Abstract

Background/Aims: The increasing expense of the drug development process has seen interest in the use of adaptive designs (ADs) grow substantially in recent years. Accordingly, much research has been conducted to identify potential barriers to increasing the use of ADs in practice, and several articles have argued that the availability of user-friendly software will be an important step in making ADs easier to implement. Therefore, in this paper we present a review of the current state of software availability for AD. Methods: We first review articles from 31 journals published in 2013-17 that relate to methodology for adaptive trials, in order to assess how often code and software for implementing novel ADs is made available at the time of publication. We contrast our findings against these journals' current policies on code distribution. Secondly, we conduct additional searches of popular code repositories, such as CRAN and GitHub, to identify further existing user-contributed software for ADs. From this, we are able to direct interested parties towards solutions for their problem of interest by classifying available code by type of adaptation. Results: Only 29% of included articles made their code available in some form. In many instances, articles published in journals that had mandatory requirements on code provision still did not make code available. There are several areas in which available software is currently limited or saturated. In particular, many packages are available to address group sequential design, but comparatively little code is present in the public domain to determine biomarker-guided ADs. Conclusions: There is much room for improvement in the provision of software alongside AD publications. Additionally, whilst progress has been made, well-established software for various types of trial adaptation remains sparsely available.

Published
2019

6. Bayesian Adaptive Designs for Phase I Trials

Author

Sweeting, Michael J., Mander, Adrian P., Wheeler, Graham M., Choodari-Oskooei, Babak, Section editor, Parmar, Mahesh, Section editor, Meinert, Curtis L., Section editor, Piantadosi, Steven, Section editor, Piantadosi, Steven, editor, and Meinert, Curtis L., editor

Published
2022
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7. Effectiveness and cost-effectiveness of referral to a commercial open group behavioural weight management programme in adults with overweight and obesity: 5-year follow-up of the WRAP randomised controlled trial

Author

Ahern, Amy L, Breeze, Penny, Fusco, Francesco, Sharp, Stephen J, Islam, Nazrul, Wheeler, Graham M, Hill, Andrew J, Hughes, Carly A, Duschinsky, Robbie, Thomas, Chloe, Bates, Sarah, Woolston, Jenny, Stubbings, Marie, Whittle, Fiona, Boothby, Clare, Bostock, Jennifer, Jebb, Susan, Aveyard, Paul, Boyland, Emma, Halford, Jason C G, Morris, Stephen, Brennan, Alan, and Griffin, Simon J

Published
2022
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9. Protocol for the EACH trial: a multicentre phase II study evaluating the safety and antitumour activity of the combination of avelumab, an anti-PD-L1 agent, and cetuximab, as any line treatment for patients with recurrent/metastatic head and neck squamous cell cancer (HNSCC) in the UK

Author

Ng, Kenrick, primary, Metcalf, Rob, additional, Sacco, Joseph, additional, Kong, Anthony, additional, Wheeler, Graham, additional, Forsyth, Sharon, additional, Bhat, Reshma, additional, Ward, Joseph, additional, Ensell, Leah, additional, Lowe, Helen, additional, Spanswick, Victoria, additional, Hartley, John, additional, White, Laura, additional, Lloyd-Dehler, Elizabeth, additional, and Forster, Martin, additional

Published
2023
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14. Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial

Author

Ahern, Amy L, Wheeler, Graham M, Aveyard, Paul, Boyland, Emma J, Halford, Jason C G, Mander, Adrian P, Woolston, Jennifer, Thomson, Ann M, Tsiountsioura, Melina, Cole, Darren, Mead, Bethan R, Irvine, Lisa, Turner, David, Suhrcke, Marc, Pimpin, Laura, Retat, Lise, Jaccard, Abbygail, Webber, Laura, Cohn, Simon R, and Jebb, Susan A

Published
2017
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18. MESO-02 Trial Protocol from Ganetespib in Combination with Pemetrexed–Platinum Chemotherapy in Patients with Pleural Mesothelioma (MESO-02): A Phase Ib Trial

Author

Fennell, Dean A., primary, Danson, Sarah, primary, Woll, Penella J., primary, Forster, Martin, primary, Talbot, Denis, primary, Child, Jennifer, primary, Farrelly, Laura, primary, Sharkey, Annabel, primary, Busacca, Sara, primary, Ngai, Yenting, primary, Hackshaw, Allan, primary, and Wheeler, Graham M., primary

Published
2023
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19. Supplementary Data from Ganetespib in Combination with Pemetrexed–Platinum Chemotherapy in Patients with Pleural Mesothelioma (MESO-02): A Phase Ib Trial

Author

Fennell, Dean A., primary, Danson, Sarah, primary, Woll, Penella J., primary, Forster, Martin, primary, Talbot, Denis, primary, Child, Jennifer, primary, Farrelly, Laura, primary, Sharkey, Annabel, primary, Busacca, Sara, primary, Ngai, Yenting, primary, Hackshaw, Allan, primary, and Wheeler, Graham M., primary

Published
2023
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20. Response to Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”

Author

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

Published
2022
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25. Visualising harms in publications of randomised controlled trials: consensus and recommendations

Author

Phillips, Rachel, primary, Cro, Suzie, additional, Wheeler, Graham, additional, Bond, Simon, additional, Morris, Tim P, additional, Creanor, Siobhan, additional, Hewitt, Catherine, additional, Love, Sharon, additional, Lopes, Andre, additional, Schlackow, Iryna, additional, Gamble, Carrol, additional, MacLennan, Graeme, additional, Habron, Chris, additional, Gordon, Anthony C, additional, Vergis, Nikhil, additional, Li, Tianjing, additional, Qureshi, Riaz, additional, Everett, Colin C, additional, Holmes, Jane, additional, Kirkham, Amanda, additional, Peckitt, Clare, additional, Pirrie, Sarah, additional, Ahmed, Norin, additional, Collett, Laura, additional, and Cornelius, Victoria, additional

Published
2022
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26. Early phase clinical trials extension to guidelines for the content of statistical analysis plans

Author

Homer, Victoria, primary, Yap, Christina, additional, Bond, Simon, additional, Holmes, Jane, additional, Stocken, Deborah, additional, Walker, Katrina, additional, Robinson, Emily J, additional, Wheeler, Graham, additional, Brown, Sarah, additional, Hinsley, Samantha, additional, Schipper, Matthew, additional, Weir, Christopher J, additional, Rantell, Khadija, additional, Prior, Thomas, additional, Yu, Ly-Mee, additional, Kirkpatrick, John, additional, Bedding, Alun, additional, Gamble, Carrol, additional, and Gaunt, Piers, additional

Published
2022
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28. Durable Responses and Low Toxicity After Fast Off-Rate CD19 Chimeric Antigen Receptor-T Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Author

Roddie, Claire, primary, Dias, Juliana, additional, O'Reilly, Maeve A., additional, Abbasian, Mahnaz, additional, Cadinanos-Garai, Amaia, additional, Vispute, Ketki, additional, Bosshard-Carter, Leticia, additional, Mitsikakou, Marina, additional, Mehra, Vedika, additional, Roddy, Harriet, additional, Hartley, John A., additional, Spanswick, Victoria, additional, Lowe, Helen, additional, Popova, Bilyana, additional, Clifton-Hadley, Laura, additional, Wheeler, Graham, additional, Olejnik, Joanna, additional, Bloor, Adrian, additional, Irvine, David, additional, Wood, Leigh, additional, Marzolini, Maria A. V., additional, Domning, Sabine, additional, Farzaneh, Farzin, additional, Lowdell, Mark W., additional, Linch, David C., additional, Pule, Martin A., additional, and Peggs, Karl S., additional

Published
2021
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30. Abstract LB004: Nivolumab (NIVO) and ipilimumab (IPI) treatment in prostate cancer with an immunogenic signature: cohort 1 of the NEPTUNES multi-centre, two-stage biomarker-selected Phase II trial

Author

Linch, Mark D., primary, Wong, Yien Ning Sophia, additional, Jones, Robert, additional, Sankey, Peter, additional, Josephs, Debra H., additional, Crabb, Simon J., additional, Staffurth, John, additional, Zarkar, Anjali, additional, White, Laura, additional, Duggan, Marian, additional, Pellizzari, Giulia, additional, Wheeler, Graham, additional, Beare, Sandy, additional, Cartwright, Hayley, additional, Linares, Josep, additional, Akarca, Ayse, additional, Quezada, Sergio A., additional, Ensell, Leah, additional, Hartley, John, additional, Attard, Gerhardt, additional, Burr, Joanna, additional, Jayaram, Anuradha, additional, Kularatne, Bihani, additional, Kayani, Mahaz, additional, Chung, Moon, additional, Pritchard, Colin C., additional, Freeman, Alex, additional, Haider, Aiman, additional, and Marafioti, Teresa, additional

Published
2021
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31. The effect of referral to an open-group behavioural weight-management programme on the relative risk of normoglycaemia, non-diabetic hyperglycaemia and type 2 diabetes: Secondary analysis of the WRAP trial

Author

Ahern, Amy L, Griffin, Simon J, Wheeler, Graham M, Sharp, Stephen J, Aveyard, Paul, Boyland, Emma J, Halford, Jason CG, Jebb, Susan A, Ahern, Amy L [0000-0001-5069-4758], and Apollo - University of Cambridge Repository

Subjects
Adult, Risk, Weight Reduction Programs, Adolescent, Diabetes Mellitus, Type 2, Hyperglycemia, Humans, diabetes, non-diabetic hyperglycaemia, obesity, prevention, weight loss, Referral and Consultation
Abstract

AIM: To examine the impact of open-group behavioural weight-management programmes on the risk of diabetes among those with a body mass index (BMI) of ≥28 kg/m2 and those with non-diabetic hyperglycaemia (NDH). METHODS: This was a secondary analysis of data from the WRAP trial, in which participants (N = 1267; aged ≥18 years, BMI ≥ 28 kg/m2 ) were randomized to brief intervention (BI; self-help booklet), a weight-management programme (WW; formerly Weight Watchers) for 12 weeks, or WW for 52 weeks. We used multinomial logistic regression to examine the effect of intervention group on the risk of hyperglycaemia and diabetes at 12 months in all participants with glycaemic status at both time points (N = 480; 38%) and those with NDH at baseline (N = 387; 31%). We used mixed effects models and linear fixed effects models to examine the effect of intervention group on body weight and HbA1c at 12 months in people with NDH. RESULTS: There was a 61% relative reduction in the risk of NDH at the 12-month follow-up (12 weeks vs. BI: relative risk ratio [RRR] = 0.39 [95% CI 0.18, 0.87], P = .021; 52 weeks vs. BI: RRR = 0.38 [95% CI 0.17, 0.86], P = .020). For intervention effects on the risk of diabetes, confidence intervals were wide and overlapped 1 [12 weeks vs. BI: RRR = 0.49 [95% CI 0.12, 1.96], P = .312; 52 weeks vs. BI: RRR = 0.40 [95% CI 0.10, 1.63], P = .199). Participants with hyperglycaemia at baseline in the weight-management programme were more probable to have normoglycaemia at the 12-month follow-up [12-week programme vs. BI: RRR = 3.57 [95% CI 1.24, 10.29], P = .019; 52-week programme vs. BI: RRR = 4.14 [95% CI 1.42, 12.12], P = .009). CONCLUSIONS: Open-group behavioural weight-management programmes can help to prevent the development of NDH in people with overweight and obesity and to normalize glycaemia in people with NDH.

Published
2020

32. Supplemental_Material – Supplemental material for A review of available software for adaptive clinical trial design

Author

Grayling, Michael John and Wheeler, Graham Mark

Subjects
FOS: Clinical medicine, 160807 Sociological Methodology and Research Methods, behavioral disciplines and activities, humanities, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, FOS: Sociology
Abstract

Supplemental material, Supplemental_Material for A review of available software for adaptive clinical trial design by Michael John Grayling and Graham Mark Wheeler in Clinical Trials

Published
2020
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35. ALLCAR19: Updated Data Using AUTO1, a Novel Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia and Other B-Cell Malignancies

Author

Roddie, Claire, primary, O'Reilly, Maeve A, additional, Marzolini, Maria A V, additional, Wood, Leigh, additional, Dias, Juliana, additional, Cadinanos Garai, Amaia, additional, Bosshard, Leticia, additional, Abbasian, Mahnaz, additional, Lowdell, Mark W., additional, Wheeler, Graham, additional, Olejnik, Joanna, additional, Popova, Bilyana, additional, Clifton-Hadley, Laura, additional, Pathak, Yashma, additional, Spanswick, Victoria, additional, Lowe, Helen, additional, Hartley, John A., additional, Syed, Farhatullah, additional, Qasim, Waseem, additional, Farzaneh, Farzin, additional, Linch, David C., additional, Pule, Martin, additional, and Peggs, Karl S, additional

Published
2020
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37. Ganetespib in Combination with Pemetrexed–Platinum Chemotherapy in Patients with Pleural Mesothelioma (MESO-02): A Phase Ib Trial

Author

Fennell, Dean A., primary, Danson, Sarah, additional, Woll, Penella J., additional, Forster, Martin, additional, Talbot, Denis, additional, Child, Jennifer, additional, Farrelly, Laura, additional, Sharkey, Annabel, additional, Busacca, Sara, additional, Ngai, Yenting, additional, Hackshaw, Allan, additional, and Wheeler, Graham M., additional

Published
2020
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38. The effect of referral to an open‐group behavioural weight‐management programme on the relative risk of normoglycaemia, non‐diabetic hyperglycaemia and type 2 diabetes: Secondary analysis of the WRAP trial

Author

Ahern, Amy L., primary, Griffin, Simon J., additional, Wheeler, Graham M., additional, Sharp, Stephen J., additional, Aveyard, Paul, additional, Boyland, Emma J., additional, Halford, Jason C. G., additional, and Jebb, Susan A., additional

Published
2020
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43. Automated Manufacture of Matched Donor-Derived Allogeneic CD19 CAR T-Cells for Relapsed/Refractory B-ALL Following Allogeneic Stem Cell Transplantation: Toxicity, Efficacy and the Important Role of Lymphodepletion

Author

Roddie, Claire, primary, O'Reilly, Maeve A, primary, Marzolini, Maria A V, primary, Wood, Leigh, primary, Dias Alves Pinto, Juliana, primary, Abbasian, Mahnaz, primary, Vispute, Ketki, primary, Bosshard, Leticia, primary, Lowdell, Mark W., primary, Wheeler, Graham, primary, Day, Alex, primary, Popova, Bilyana, primary, Champion, Kim, primary, Pathak, Yashma, primary, Gali, Alexia, primary, Mahmoud, Nasir, primary, Spanswick, Victoria, primary, Lowe, Helen, primary, Hartley, John A., primary, Farzaneh, Farzin, primary, Nickolay, Lauren, primary, Syed, Fahetullah, primary, Qasim, Waseem, primary, Linch, David C., primary, Pule, Martin, primary, and Peggs, Karl S, primary

Published
2019
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44. AUTO1, a Novel Fast Off CD19CAR Delivers Durable Remissions and Prolonged CAR T Cell Persistence with Low CRS or Neurotoxicity in Adult ALL

Author

Roddie, Claire, primary, O'Reilly, Maeve A, primary, Marzolini, Maria A V, primary, Wood, Leigh, primary, Dias Alves Pinto, Juliana, primary, Abbasian, Mahnaz, primary, Vispute, Ketki, primary, Lowdell, Mark W., primary, Wheeler, Graham, primary, Olejnik, Joanna, primary, Popova, Bilyana, primary, Champion, Kim, primary, Gali, Alexia, primary, Pathak, Yashma, primary, Spanswick, Victoria, primary, Lowe, Helen, primary, Hartley, John A., primary, Farzaneh, Farzin, primary, Linch, David C., primary, Pule, Martin, primary, and Peggs, Karl S, primary

Published
2019
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45. A Bayesian model-free approach to combination therapy phase I trials using censored time-to-toxicity data

Author

Wheeler, Graham M, Sweeting, Michael J, Mander, Adrian P, Mander, Adrian [0000-0002-0742-9040], and Apollo - University of Cambridge Repository

Subjects
Clinical trials, Bayesian methods, Dose escalation, Model-free, Time-to-event, Adaptive designs
Abstract

The product of independent beta probabilities escalation (PIPE) design for dual-agent phase I dose-escalation trials is a Bayesian model-free approach for identifying multiple maximum tolerated dose combinations of novel combination therapies. Despite only being published in 2015, the PIPE design has been implemented in at least two oncology trials. However, these trials require patients to have completed follow-up before clinicians can make dose-escalation decisions. For trials of radiotherapy or advanced therapeutics, this may lead to impractically long trial durations due to late-onset treatment-related toxicities. In this paper, we extend the PIPE design to use censored time-to-event (TITE) toxicity outcomes for making dose escalation decisions. We show via comprehensive simulation studies and sensitivity analyses that trial duration can be reduced by up to 35%, particularly when recruitment is faster than expected, without compromising on other operating characteristics.

Published
2019

47. Abstract CT105: AUTO1, a novel fast off CD19CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALL

Author

Roddie, Claire, primary, O'Reilly, Maeve A., additional, Pinto, Juliana Dias Alves, additional, Vispute, Ketki, additional, Syed, Fahetullah, additional, Nickolay, Lauren, additional, Pathak, Yashma, additional, Gali, Alexia, additional, Lowe, Helen, additional, Champion, Kim, additional, Wheeler, Graham, additional, Olejnik, Jo, additional, Marzolini, Maria, additional, Pule, Martin A., additional, and Peggs, Karl S., additional

Published
2019
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48. Nivolumab and ipilimumab treatment in prostate cancer with an immunogenic signature (NEPTUNES).

Author

Wong, Yien Ning Sophia, primary, Sankey, Peter, additional, Josephs, Debra Hannah, additional, Jones, Robert J, additional, Crabb, Simon J., additional, Beare, Sandy, additional, Duggan, Marian, additional, White, Laura, additional, Charlaftis, Nikolaos, additional, Wheeler, Graham, additional, Linares, Josep, additional, Quezada, Sergio A., additional, Ensell, Leah, additional, Flanagan, Cliona, additional, Kularatne, Bihani Yoshana, additional, Chung, Moon, additional, Pritchard, Colin C., additional, Freeman, Alex, additional, Marafioti, Teresa, additional, and Linch, Mark David, additional

Published
2019
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49. EACH: A randomised phase II study evaluating the safety and anti-tumour activity of the combination of avelumab and cetuximab relative to avelumab monotherapy in recurrent/metastatic head and neck squamous cell cancer.

Author

Forster, Martin David, primary, Sacco, Joseph J., additional, Kong, Anthony Hee, additional, Wheeler, Graham, additional, Forsyth, Sharon, additional, Bhat, Reshma, additional, Blair, Kameka, additional, Lowe, Helen, additional, Spanswick, Victoria J, additional, Ensell, Leah, additional, Hartley, John A., additional, and White, Laura, additional

Published
2019
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50. TACTICAL: A phase I/II trial to assess the safety and efficacy of MSCTRAIL in the treatment of metastatic lung adenocarcinoma.

Author

Davies, Alice, primary, Sage, Beth, additional, Kolluri, Krishna, additional, Alrifai, Doraid, additional, Graham, Rebecca, additional, Weil, Ben, additional, Rego, Rita, additional, Bain, Owen, additional, Patrick, P. Stephen, additional, Champion, Kim, additional, Day, Alex, additional, Popova, Bilyana, additional, Wheeler, Graham, additional, Fullen, Dan, additional, Kalbur, Tammy, additional, Forster, Martin, additional, Lowdell, Mark, additional, and Janes, Sam, additional

Published
2019
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