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Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network
- Karen Lane, Marisha E. Palm, Eve Marion, Marie T. Kay, Dixie Thompson, Mary Stroud, Helen Boyle, Shannon Hillery, Angeline Nanni, Meghan Hildreth, Sarah Nelson, Jeri S. Burr, Terri Edwards, Lori Poole, Salina P. Waddy, Sarah E. Dunsmore, Paul Harris, Consuelo Wilkins, Gordon R. Bernard, J. Michael Dean, Jamie Dwyer, Daniel K. Benjamin, Jr., Harry P. Selker, Daniel F. Hanley, Daniel E. Ford
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
- Published online by Cambridge University Press:
- 25 May 2023, e131
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One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
Characterisation of age and polarity at onset in bipolar disorder
- Janos L. Kalman, Loes M. Olde Loohuis, Annabel Vreeker, Andrew McQuillin, Eli A. Stahl, Douglas Ruderfer, Maria Grigoroiu-Serbanescu, Georgia Panagiotaropoulou, Stephan Ripke, Tim B. Bigdeli, Frederike Stein, Tina Meller, Susanne Meinert, Helena Pelin, Fabian Streit, Sergi Papiol, Mark J. Adams, Rolf Adolfsson, Kristina Adorjan, Ingrid Agartz, Sofie R. Aminoff, Heike Anderson-Schmidt, Ole A. Andreassen, Raffaella Ardau, Jean-Michel Aubry, Ceylan Balaban, Nicholas Bass, Bernhard T. Baune, Frank Bellivier, Antoni Benabarre, Susanne Bengesser, Wade H Berrettini, Marco P. Boks, Evelyn J. Bromet, Katharina Brosch, Monika Budde, William Byerley, Pablo Cervantes, Catina Chillotti, Sven Cichon, Scott R. Clark, Ashley L. Comes, Aiden Corvin, William Coryell, Nick Craddock, David W. Craig, Paul E. Croarkin, Cristiana Cruceanu, Piotr M. Czerski, Nina Dalkner, Udo Dannlowski, Franziska Degenhardt, Maria Del Zompo, J. Raymond DePaulo, Srdjan Djurovic, Howard J. Edenberg, Mariam Al Eissa, Torbjørn Elvsåshagen, Bruno Etain, Ayman H. Fanous, Frederike Fellendorf, Alessia Fiorentino, Andreas J. Forstner, Mark A. Frye, Janice M. Fullerton, Katrin Gade, Julie Garnham, Elliot Gershon, Michael Gill, Fernando S. Goes, Katherine Gordon-Smith, Paul Grof, Jose Guzman-Parra, Tim Hahn, Roland Hasler, Maria Heilbronner, Urs Heilbronner, Stephane Jamain, Esther Jimenez, Ian Jones, Lisa Jones, Lina Jonsson, Rene S. Kahn, John R. Kelsoe, James L. Kennedy, Tilo Kircher, George Kirov, Sarah Kittel-Schneider, Farah Klöhn-Saghatolislam, James A. Knowles, Thorsten M. Kranz, Trine Vik Lagerberg, Mikael Landen, William B. Lawson, Marion Leboyer, Qingqin S. Li, Mario Maj, Dolores Malaspina, Mirko Manchia, Fermin Mayoral, Susan L. McElroy, Melvin G. McInnis, Andrew M. McIntosh, Helena Medeiros, Ingrid Melle, Vihra Milanova, Philip B. Mitchell, Palmiero Monteleone, Alessio Maria Monteleone, Markus M. Nöthen, Tomas Novak, John I. Nurnberger, Niamh O'Brien, Kevin S. O'Connell, Claire O'Donovan, Michael C. O'Donovan, Nils Opel, Abigail Ortiz, Michael J. Owen, Erik Pålsson, Carlos Pato, Michele T. Pato, Joanna Pawlak, Julia-Katharina Pfarr, Claudia Pisanu, James B. Potash, Mark H Rapaport, Daniela Reich-Erkelenz, Andreas Reif, Eva Reininghaus, Jonathan Repple, Hélène Richard-Lepouriel, Marcella Rietschel, Kai Ringwald, Gloria Roberts, Guy Rouleau, Sabrina Schaupp, William A Scheftner, Simon Schmitt, Peter R. Schofield, K. Oliver Schubert, Eva C. Schulte, Barbara Schweizer, Fanny Senner, Giovanni Severino, Sally Sharp, Claire Slaney, Olav B. Smeland, Janet L. Sobell, Alessio Squassina, Pavla Stopkova, John Strauss, Alfonso Tortorella, Gustavo Turecki, Joanna Twarowska-Hauser, Marin Veldic, Eduard Vieta, John B. Vincent, Wei Xu, Clement C. Zai, Peter P. Zandi, Psychiatric Genomics Consortium (PGC) Bipolar Disorder Working Group, International Consortium on Lithium Genetics (ConLiGen), Colombia-US Cross Disorder Collaboration in Psychiatric Genetics, Arianna Di Florio, Jordan W. Smoller, Joanna M. Biernacka, Francis J. McMahon, Martin Alda, Bertram Müller-Myhsok, Nikolaos Koutsouleris, Peter Falkai, Nelson B. Freimer, Till F.M. Andlauer, Thomas G. Schulze, Roel A. Ophoff
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- Journal:
- The British Journal of Psychiatry / Volume 219 / Issue 6 / December 2021
- Published online by Cambridge University Press:
- 25 August 2021, pp. 659-669
- Print publication:
- December 2021
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Background
Studying phenotypic and genetic characteristics of age at onset (AAO) and polarity at onset (PAO) in bipolar disorder can provide new insights into disease pathology and facilitate the development of screening tools.
AimsTo examine the genetic architecture of AAO and PAO and their association with bipolar disorder disease characteristics.
MethodGenome-wide association studies (GWASs) and polygenic score (PGS) analyses of AAO (n = 12 977) and PAO (n = 6773) were conducted in patients with bipolar disorder from 34 cohorts and a replication sample (n = 2237). The association of onset with disease characteristics was investigated in two of these cohorts.
ResultsEarlier AAO was associated with a higher probability of psychotic symptoms, suicidality, lower educational attainment, not living together and fewer episodes. Depressive onset correlated with suicidality and manic onset correlated with delusions and manic episodes. Systematic differences in AAO between cohorts and continents of origin were observed. This was also reflected in single-nucleotide variant-based heritability estimates, with higher heritabilities for stricter onset definitions. Increased PGS for autism spectrum disorder (β = −0.34 years, s.e. = 0.08), major depression (β = −0.34 years, s.e. = 0.08), schizophrenia (β = −0.39 years, s.e. = 0.08), and educational attainment (β = −0.31 years, s.e. = 0.08) were associated with an earlier AAO. The AAO GWAS identified one significant locus, but this finding did not replicate. Neither GWAS nor PGS analyses yielded significant associations with PAO.
ConclusionsAAO and PAO are associated with indicators of bipolar disorder severity. Individuals with an earlier onset show an increased polygenic liability for a broad spectrum of psychiatric traits. Systematic differences in AAO across cohorts, continents and phenotype definitions introduce significant heterogeneity, affecting analyses.
Contributors
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- By Victoria M. Allen, Frederic Amant, Sarah Armstrong, Thomas F. Baskett, Michael A. Belfort, Meredith Birsner, Renee D. Boss, Leanne Bricker, Josaphat K. Byamugisha, Giorgio Capogna, Michael P. Casaer, Frank A. Chervenak, Vicki Clark, Filip Claus, Malachy O. Columb, Charles Cox, Jean T. Cox, Vegard Dahl, John Davison, Jan Deprest, Clifford S. Deutschman, Roland Devlieger, Karim Djekidel, Steven Dymarkowski, Roshan Fernando, Clare Fitzpatrick, Sreedhar Gaddipati, Thierry Girard, Emily Gordon, Ian A. Greer, David Grooms, Sina Haeri, Katy Harrison, Edward J. Hayes, Michelle Hladunewich, Andra H. James, Tracey Johnston, Bellal Joseph, Erin Keely, Ruth Landau, Stephen E. Lapinsky, Susanna I. Lee, Larry Leeman, Hennie Lombaard, Stephen Lu, Alison MacArthur, Laura A. Magee, Paul E. Marik, Laurence B. McCullough, Alexandre Mignon, Carlo Missant, Jack Moodley, Lisa E. Moore, Kate Morse, Warwick D. Ngan Kee, Catherine Nelson-Piercy, Clemens M. Ortner, Geraldine O’Sullivan, Luis D. Pacheco, Fathima Paruk, Melina Pectasides, Nigel Pereira, Patricia Peticca, Sharon T. Phelan, Felicity Plaat, Lauren A. Plante, Michael P. Plevyak, Dianne Plews, Wendy Pollock, Laura C. Price, Peter Rhee, Leiv Arne Rosseland, Kathryn M. Rowan, Helen Ryan, Helen Scholefield, Neil S. Seligman, Nadir Sharawi, Alex Sia, Bob Silver, Mieke Soens, Ulrich J. Spreng, Silvia Stirparo, Nova Szoka, Andrew Tang, Kha M. Tran, Els Troost, Lawrence C. Tsen, Derek Tuffnell, Kristel Van Calsteren, Marc Van de Velde, Marcel Vercauteren, Chris Verslype, Peter von Dadelszen, Carl Waldman, Michelle Walters, Linda Watkins, Paul Westhead, Cynthia A. Wong, Gerda G. Zeeman, Joost J. Zwart
- Edited by Marc van de Velde, Helen Scholefield, Lauren A. Plante
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- Book:
- Maternal Critical Care
- Published online:
- 05 July 2013
- Print publication:
- 04 July 2013, pp ix-xiv
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- By Avishek Adhikari, Susanne E. Ahmari, Anne Marie Albano, Carlos Blanco, Desiree K. Caban, Jonathan S. Comer, Jeremy D. Coplan, Ana Alicia De La Cruz, Emily R. Doherty, Bruce Dohrenwend, Amit Etkin, Brian A. Fallon, Michael B. First, Abby J. Fyer, Angela Ghesquiere, Jay A. Gingrich, Robert A. Glick, Joshua A. Gordon, Ethan E. Gorenstein, Marco A. Grados, James P. Hambrick, James Hanks, Kelli Jane K. Harding, Richard G. Heimberg, Rene Hen, Devon E. Hinton, Myron A. Hofer, Matthew J. Kaplowitz, Sharaf S. Khan, Donald F. Klein, Karestan C. Koenen, E. David Leonardo, Roberto Lewis-Fernández, Jeffrey A. Lieberman, Michael R. Liebowitz, Sarah H. Lisanby, Antonio Mantovani, John C. Markowitz, Patrick J. McGrath, Caitlin McOmish, Jeffrey M. Miller, Jan Mohlman, Elizabeth Sagurton Mulhare, Philip R. Muskin, Navin Arun Natarajan, Yuval Neria, Nicole R. Nugent, Mayumi Okuda, Mark Olfson, Laszlo A. Papp, Sapana R. Patel, Anthony Pinto, Kristin Pontoski, Jesse W. Richardson-Jones, Carolyn I. Rodriguez, Steven P. Roose, Moira A. Rynn, Franklin Schneier, M. Katherine Shear, Ranjeeb Shrestha, Helen Blair Simpson, Smit S. Sinha, Natalia Skritskaya, Jami Socha, Eun Jung Suh, Gregory M. Sullivan, Anthony J. Tranguch, Hilary B. Vidair, Tor D. Wager, Myrna M Weissman, Noelia V. Weisstaub
- Edited by Helen Blair Simpson, Columbia University, New York, Yuval Neria, Columbia University, New York, Roberto Lewis-Fernández, Columbia University, New York, Franklin Schneier, Columbia University, New York
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- Book:
- Anxiety Disorders
- Published online:
- 10 November 2010
- Print publication:
- 26 August 2010, pp vii-xii
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- By Pina Amin, Sir Sabaratnam Arulkumaran, Sarah L. Bell, M. J. Blott, Hajeera Butt, Edwin Chandraharan, Joanna Crofts, Mark Denbow, Mandish K. Dhanjal, Stergios K. Doumouchtsis, Timothy J. Draycott, Rohan D'Souza, David Fraser, Guy Jackson, Nina Johns, Tracey Johnston, Justin C. Konje, Audrey Long, Louay S. Louis, Paul A. Mannix, Mahishee Mehta, Nutan Mishra, Sambit Mukhopadhyay, Deirdre J. Murphy, Vivek Nama, Osric Navti, Catherine Nelson-Piercy, Jane E. Norman, Geraldine O'Sullivan, Sara Paterson-Brown, Leonie Penna, Neelam Potdar, Helen Scholefield, Jason Scott, Dimitrios M. Siassakos, Gordon C. S. Smith, Lisa Story, Bryony Strachan, Devi Subramanian, Abdul H. Sultan, Ranee Thakar, Austin Ugwumadu, Rajesh Varma, James J. Walker, Steve Walkinshaw, Richard Warren, Melissa Whitten, Melissa K. Whitworth, Julian Woolfson, Steve Yentis
- Edited by Richard Warren, Sabaratnam Arulkumaran
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- Book:
- Best Practice in Labour and Delivery
- Published online:
- 15 March 2010
- Print publication:
- 17 September 2009, pp vii-x
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14 - Audit in obstetrics and gynaecology
- Edited by Simon P. Frostick, Department of Orthopaedic and Accident Surgery, University Hospital, Nottingham, UK, Philip J. Radford, Department of Orthopaedic and Accident Surgery, University Hospital, Nottingham, UK, W. Angus Wallace, Department of Orthopaedic and Accident Surgery, University Hospital, Nottingham, UK
- Foreword by Kenneth Calman, Terence English
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- Book:
- Medical Audit
- Published online:
- 30 September 2009
- Print publication:
- 19 August 1993, pp 187-200
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Summary
Introduction
The basic ideas of ‘Health for All by the Year 2000’ were outlined in 1978 at the Alma Ata Conference organised by the World Health Organisation (WHO) and the United Nations Children's Fund (UNICEF). Subsequently, the WHO Regional Office for Europe devised criteria to monitor some practical ways of implementing the basic ideas and in their document they suggest ‘By 1990, all members states should have built effective mechanisms for ensuring the quality of care within their health care systems’. Medical audit is one way of monitoring the mechanisms implemented to ensure the quality of care and indeed, medical audit is a key part of the UK's White Paper that proposed reconstruction of the National Health Service.
Maternal mortality audit
Maternal mortality audit is not a new phenomenon in the specialty of obstetrics and gynaecology. In Scotland, for example, the first special enquiry into maternal deaths was instituted in 1930 by agreement between the Scottish Board of Health, the local authorities and the medical professional organisations. The perinatal mortality rate was first recorded in Scotland in 1939, when it was 68 per 1000 total births. The information elicited by the first enquiry led directly to the Maternity Services (Scotland) Act of 1937 and laid the foundation for the immeasurably improved hospital services of today.