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1. Predictive Probabilities Made Simple: A Fast and Accurate Method for Clinical Trial Decision Making

Author

Marion, Joe, Lorenzi, Liz, Allen-Savietta, Cora, Berry, Scott, and Viele, Kert

Subjects
Statistics - Applications
Abstract

Bayesian predictive probabilities are commonly used for interim monitoring of clinical trials through efficacy and futility stopping rules. Despite their usefulness, calculation of predictive probabilities, particularly in pre-experiment trial simulation, can be a significant challenge. We introduce an approximation for computing predictive probabilities using either a p-value or a posterior probability that significantly reduces this burden. We show the approximation has a high degree of concordance with standard Monte Carlo imputation methods for computing predictive probabilities, and present five simulation studies comparing the approximation to the full predictive probability for a range of primary analysis strategies: dichotomous, time-to-event, and ordinal endpoints, as well as historical borrowing and longitudinal modeling. We find that this faster method of predictive probability approximation works well in all five applications, thus significantly reducing the computational burden of trial simulation, allowing more virtual trials to be simulated to achieve greater precision in estimating trial operating characteristics., Comment: under review

Published
2024

3. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial

Author

Agyeman, Akosua A, Ahmed, Tanveer, Allcock, Damien, Beltran-Martinez, Adrian, Benedict, Oluseye E, Bird, Nigel, Brennan, Laura, Brown, Julianne, Burns, Gerard, Butler, Mike, Cheng, Zelda, Danson, Ruth, de Kare-Silver, Nigel, Dhasmana, Devesh, Dickson, Jon, Engamba, Serge, Fisher, Stacey, Fox, Robin, Frost, Eve, Gaunt, Richard, Ghosh, Sarit, Gilkar, Ishtiaq, Goodman, Anna, Granier, Steve, Howell, Aleksandra, Hussain, Iqbal, Hutchinson, Simon, Imlach, Marie, Irving, Greg, Jacobsen, Nicholas, Kennard, James, Khan, Umar, Knox, Kyle, Krasucki, Christopher, Law, Tom, Lee, Rem, Lester, Nicola, Lewis, David, Lunn, James, Mackintosh, Claire I., Mathukia, Mehul, Moore, Patrick, Morton, Seb, Murphy, Daniel, Nally, Rhiannon, Ndukauba, Chinonso, Ogundapo, Olufunto, Okeke, Henry, Patel, Amit, Patel, Kavil, Penfold, Ruth, Poonian, Satveer, Popoola, Olajide, Pora, Alexander, Prasad, Vibhore, Prasad, Rishabh, Razzaq, Omair, Richardson, Scot, Royal, Simon, Safa, Afsana, Sehdev, Satash, Sevenoaks, Tamsin, Shah, Divya, Sheikh, Aadil, Short, Vanessa, Sidhu, Baljinder S, Singh, Ivor, Soni, Yusuf, Thalasselis, Chris, Wilson, Pete, Wingfield, David, Wong, Michael, Woodall, Maximillian N J, Wooding, Nick, Woods, Sharon, Yong, Joanna, Yongblah, Francis, Zafar, Azhar, Butler, Christopher C, Hobbs, F D Richard, Gbinigie, Oghenekome A, Rahman, Najib M, Hayward, Gail, Richards, Duncan B, Dorward, Jienchi, Lowe, David M, Standing, Joseph F, Breuer, Judith, Khoo, Saye, Petrou, Stavros, Hood, Kerenza, Nguyen-Van-Tam, Jonathan S, Patel, Mahendra G, Saville, Benjamin R, Marion, Joe, Ogburn, Emma, Allen, Julie, Rutter, Heather, Francis, Nick, Thomas, Nicholas P B, Evans, Philip, Dobson, Melissa, Madden, Tracie-Ann, Holmes, Jane, Harris, Victoria, Png, May Ee, Lown, Mark, van Hecke, Oliver, Detry, Michelle A, Saunders, Christina T, Fitzgerald, Mark, Berry, Nicholas S, Mwandigha, Lazaro, Galal, Ushma, Mort, Sam, Jani, Bhautesh D, Hart, Nigel D, Ahmed, Haroon, Butler, Daniel, McKenna, Micheal, Chalk, Jem, Lavallee, Layla, Hadley, Elizabeth, Cureton, Lucy, Benysek, Magdalena, Andersson, Monique, Coates, Maria, Barrett, Sarah, Bateman, Clare, Davies, Jennifer C, Raymundo-Wood, Ivy, Ustianowski, Andrew, Carson-Stevens, Andrew, Yu, Ly-Mee, and Little, Paul

Published
2023
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4. Finite Sample Complexity of Sequential Monte Carlo Estimators

Author

Marion, Joe, Mathews, Joseph, and Schmidler, Scott C.

Subjects
Statistics - Computation, Mathematics - Probability, Statistics - Methodology, 60J22, 65C40, 65C60
Abstract

We present bounds for the finite sample error of sequential Monte Carlo samplers on static spaces. Our approach explicitly relates the performance of the algorithm to properties of the chosen sequence of distributions and mixing properties of the associated Markov kernels. This allows us to give the first finite sample comparison to other Monte Carlo schemes. We obtain bounds for the complexity of sequential Monte Carlo approximations for a variety of target distributions including finite spaces, product measures, and log-concave distributions including Bayesian logistic regression. The bounds obtained are within a logarithmic factor of similar bounds obtainable for Markov chain Monte Carlo., Comment: Revisions to the proof. Updates to formatiing

Published
2018

5. Publisher Correction: Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection

Author

Khanna, Sahil, Assi, Maha, Lee, Christine, Yoho, David, Louie, Thomas, Knapple, Whitfield, Aguilar, Humberto, Garcia-Diaz, Julia, Wang, Gary P., Berry, Scott M., Marion, Joe, Su, Xin, Braun, Tricia, Bancke, Lindy, and Feuerstadt, Paul

Published
2022
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6. Optimal sample size division in two‐stage seamless designs.

Author

Berry, Lindsay R., Marion, Joe, Berry, Scott M., and Viele, Kert

Abstract

Inferentially seamless 2/3 designs are increasingly popular in clinical trials. It is important to understand their relative advantages compared with separate phase 2 and phase 3 trials, and to understand the consequences of design choices such as the proportion of patients included in the phase 2 portion of the design. Extending previous work in this area, we perform a simulation study across multiple numbers of arms and efficacy response curves. We consider a design space crossing the choice of a separate versus seamless design with the choice of allocating 0%–100% of available patients in phase 2, with the remainder in phase 3. The seamless designs achieve greater power than their separate trial counterparts. Importantly, the optimal seamless design is more robust than the optimal separate program, meaning that one range of values for the proportion of patients used in phase 2 (30%–50% of the total phase 2/3 sample size) is nearly optimal for a wide range of response scenarios. In contrast, a percentage of patients used in phase 2 for separate trials may be optimal for some alternative scenarios but decidedly inferior for other alternative scenarios. When operationally and scientifically viable, seamless trials provide superior performance compared with separate phase 2 and phase 3 trials. The results also provide guidance for the implementation of these trials in practice. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Platform adaptive trial of novel antivirals for early treatment of COVID-19 In the community (PANORAMIC): protocol for a randomised, controlled, open-label, adaptive platform trial of community novel antiviral treatment of COVID-19 in people at increased risk of more severe disease

Author

Gbinigie, Oghenekome, primary, Ogburn, Emma, additional, Allen, Julie, additional, Dorward, Jienchi, additional, Dobson, Melissa, additional, Madden, Tracie-Ann, additional, Yu, Ly-Mee, additional, Lowe, David M, additional, Rahman, Najib, additional, Petrou, Stavros, additional, Richards, Duncan, additional, Hood, Kerenza, additional, Patel, Mahendra, additional, Saville, Benjamin R, additional, Marion, Joe, additional, Holmes, Jane, additional, Png, May Ee, additional, Hayward, Gail, additional, Lown, Mark, additional, Harris, Victoria, additional, Jani, Bhautesh, additional, Hart, Nigel, additional, Khoo, Saye, additional, Rutter, Heather, additional, Chalk, Jem, additional, Standing, Joseph F, additional, Breuer, Judith, additional, Lavallee, Layla, additional, Hadley, Elizabeth, additional, Cureton, Lucy, additional, Benysek, Magdalena, additional, Andersson, Monique I, additional, Francis, Nick, additional, Thomas, Nicholas P B, additional, Evans, Philip, additional, van Hecke, Oliver, additional, Koshkouei, Mona, additional, Coates, Maria, additional, Barrett, Sarah, additional, Bateman, Clare, additional, Davies, Jennifer, additional, Raymundo-Wood, Ivy, additional, Ustianowski, Andrew, additional, Nguyen-Van-Tam, Jonathan, additional, Carson-Stevens, Andrew, additional, Hobbs, Richard, additional, Little, Paul, additional, and Butler, Christopher C, additional

Published
2023
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10. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial

Author

Butler, Christopher C, primary, Hobbs, F D Richard, additional, Gbinigie, Oghenekome A, additional, Rahman, Najib M, additional, Hayward, Gail, additional, Richards, Duncan B, additional, Dorward, Jienchi, additional, Lowe, David M, additional, Standing, Joseph F, additional, Breuer, Judith, additional, Khoo, Saye, additional, Petrou, Stavros, additional, Hood, Kerenza, additional, Nguyen-Van-Tam, Jonathan S, additional, Patel, Mahendra G, additional, Saville, Benjamin R, additional, Marion, Joe, additional, Ogburn, Emma, additional, Allen, Julie, additional, Rutter, Heather, additional, Francis, Nick, additional, Thomas, Nicholas P B, additional, Evans, Philip, additional, Dobson, Melissa, additional, Madden, Tracie-Ann, additional, Holmes, Jane, additional, Harris, Victoria, additional, Png, May Ee, additional, Lown, Mark, additional, van Hecke, Oliver, additional, Detry, Michelle A, additional, Saunders, Christina T, additional, Fitzgerald, Mark, additional, Berry, Nicholas S, additional, Mwandigha, Lazaro, additional, Galal, Ushma, additional, Mort, Sam, additional, Jani, Bhautesh D, additional, Hart, Nigel D, additional, Ahmed, Haroon, additional, Butler, Daniel, additional, McKenna, Micheal, additional, Chalk, Jem, additional, Lavallee, Layla, additional, Hadley, Elizabeth, additional, Cureton, Lucy, additional, Benysek, Magdalena, additional, Andersson, Monique, additional, Coates, Maria, additional, Barrett, Sarah, additional, Bateman, Clare, additional, Davies, Jennifer C, additional, Raymundo-Wood, Ivy, additional, Ustianowski, Andrew, additional, Carson-Stevens, Andrew, additional, Yu, Ly-Mee, additional, Little, Paul, additional, Agyeman, Akosua A, additional, Ahmed, Tanveer, additional, Allcock, Damien, additional, Beltran-Martinez, Adrian, additional, Benedict, Oluseye E, additional, Bird, Nigel, additional, Brennan, Laura, additional, Brown, Julianne, additional, Burns, Gerard, additional, Butler, Mike, additional, Cheng, Zelda, additional, Danson, Ruth, additional, de Kare-Silver, Nigel, additional, Dhasmana, Devesh, additional, Dickson, Jon, additional, Engamba, Serge, additional, Fisher, Stacey, additional, Fox, Robin, additional, Frost, Eve, additional, Gaunt, Richard, additional, Ghosh, Sarit, additional, Gilkar, Ishtiaq, additional, Goodman, Anna, additional, Granier, Steve, additional, Howell, Aleksandra, additional, Hussain, Iqbal, additional, Hutchinson, Simon, additional, Imlach, Marie, additional, Irving, Greg, additional, Jacobsen, Nicholas, additional, Kennard, James, additional, Khan, Umar, additional, Knox, Kyle, additional, Krasucki, Christopher, additional, Law, Tom, additional, Lee, Rem, additional, Lester, Nicola, additional, Lewis, David, additional, Lunn, James, additional, Mackintosh, Claire I., additional, Mathukia, Mehul, additional, Moore, Patrick, additional, Morton, Seb, additional, Murphy, Daniel, additional, Nally, Rhiannon, additional, Ndukauba, Chinonso, additional, Ogundapo, Olufunto, additional, Okeke, Henry, additional, Patel, Amit, additional, Patel, Kavil, additional, Penfold, Ruth, additional, Poonian, Satveer, additional, Popoola, Olajide, additional, Pora, Alexander, additional, Prasad, Vibhore, additional, Prasad, Rishabh, additional, Razzaq, Omair, additional, Richardson, Scot, additional, Royal, Simon, additional, Safa, Afsana, additional, Sehdev, Satash, additional, Sevenoaks, Tamsin, additional, Shah, Divya, additional, Sheikh, Aadil, additional, Short, Vanessa, additional, Sidhu, Baljinder S, additional, Singh, Ivor, additional, Soni, Yusuf, additional, Thalasselis, Chris, additional, Wilson, Pete, additional, Wingfield, David, additional, Wong, Michael, additional, Woodall, Maximillian N J, additional, Wooding, Nick, additional, Woods, Sharon, additional, Yong, Joanna, additional, Yongblah, Francis, additional, and Zafar, Azhar, additional

Published
2023
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12. Molnupiravir Plus Usual Care Versus Usual Care Alone as Early Treatment for Adults with COVID-19 at Increased Risk of Adverse Outcomes (PANORAMIC): Preliminary Analysis from the United Kingdom Randomised, Controlled Open-Label, Platform Adaptive Trial

Author

Butler, Christopher, primary, Hobbs, F.D. Richard, additional, Gbinigie, Oghenekome, additional, Rahman, Najib M., additional, Hayward, Gail, additional, Richards, Duncan, additional, Dorward, Jienchi, additional, Lowe, David, additional, Standing, Joseph F., additional, Breuer, Judith, additional, Khoo, Saye, additional, Petrou, Stavros, additional, Hood, Kerenza, additional, Nguyen-Van-Tam, Jonathan S., additional, Patel, Mahendra, additional, Saville, Benjamin R., additional, Marion, Joe, additional, Ogburn, Emma, additional, Allen, Julie, additional, Rutter, Heather, additional, Francis, Nick, additional, Thomas, Nicholas, additional, Evans, Philip, additional, Dobson, Melissa, additional, Madden, Tracie-Ann, additional, Holmes, Jane, additional, Harris, Victoria, additional, Png, May Ee, additional, Lown, Mark, additional, van Hecke, Oliver, additional, Detry, Michelle, additional, Saunders, Christina, additional, Fitzgerald, Mark, additional, Berry, Nicholas, additional, Mwandigha, Lazaro, additional, Galal, Ushma, additional, Jani, Bhautesh, additional, Hart, Nigel, additional, Butler, Daniel, additional, Chalk, Jeremy, additional, Lavallee, Layla, additional, Hadley, Elizabeth, additional, Cureton, Lucy, additional, Benysek, Magdalena, additional, Andersson, Monique, additional, Coates, Maria, additional, Barrett, Sarah, additional, Bateman, Clare, additional, Davies, Jennifer, additional, Raymundo-Wood, Ivy, additional, Ustianowski, Andrew, additional, Carson-Stevens, Andrew, additional, Yu, Ly-Mee, additional, and Little, Paul, additional

Published
2022
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15. Correction to: Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection.

Author

Khanna, Sahil, Assi, Maha, Lee, Christine, Yoho, David, Louie, Thomas, Knapple, Whitfield, Aguilar, Humberto, Garcia-Diaz, Julia, Wang, Gary P., Berry, Scott M., Marion, Joe, Su, Xin, Braun, Tricia, Bancke, Lindy, and Feuerstadt, Paul

Subjects
DIARRHEA, CLOSTRIDIOIDES difficile, CLOSTRIDIUM diseases
Abstract

A correction to the article "Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection" that was published in the November 7, 2022 online issue is presented.

Published
2022
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16. Cardiovascular Information Systems.

Author

Marion, Joe

Subjects
CARDIOLOGY, HEALTH facilities, INFORMATION storage & retrieval systems, MEDICAL databases, ELECTRONIC health records, MEDICAL specialties & specialists, DEPARTMENTS, AMERICAN Recovery & Reinvestment Act of 2009
Abstract

The article highlights the use of electronic medical record (EMR) systems in order to collect and access the patients information across any clinical service. Robert Cecil states that patients are easily managed by EMR which will allow the department to focus on reporting and acquisitions. Tom Lonergan states that EMRs are still evolving and cardiovascular information system (CVIS) would be useful. Craig Scott reports that every physician has different outlook towards EMR and CVIS.

Published
2012

17. STUDENT SUCCESS STORY-SUNO.

Author

Marion, Joe

Subjects
*SALES executives, *EMPLOYMENT, *LABOR market
Abstract

The article presents the student success story of Brian Grant who have found success entering in the job market. Grant earned his marketing/sales major at Southern University at New Orleans (SUNO) in Louisiana and is now the territory sales manager at tobacco company Altria Group Distribution Co. It mentions that Grant managed to be named of the top sales managers within his unit, district and section of the company within his first year with the company.

Published
2015

18. MAILBOX.

Author

Marion, Joe and Minton, John

Subjects
LETTERS to the editor, DOGS, NAUTICAL mile, NAVIGATION, MEASUREMENT of distances
Abstract

Several letters to the editor are presented in response to articles in previous issues including the article "Why Not?" in the April 2009 issue, and the "Ask Bobby" column, also in the April 2009 issue.

Published
2009

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