ASPREE management was structured so that specialist committees looking after different aspects of the trial, such as the Data Management Committee, provided the ISC with accurate, timely information.
The ASPREE Investigator Group
2016 US sites
Anne Murray The Berman Center for Clinical Research (Co-PI), Andrew Chan Massachusettes General Hospital, Jamehl Demons Gerontology and Geriatric Medicine Wake Forest Clinical Trials Office, Mike Ernst University of Iowa Hospitals and Clinics, Sara Espinoza UT Health Science Center, Matthew Goetz Mayo Clinic Cancer Center, Brenda Kirpach The Berman Center for Clinical Research, Karen L Margolis HealthPartners Institute for Education & Research, Frank Meyskens UCI Chao Family Comprehensive Cancer Center, Biological Chemistry, School of Medicine, Raj Shah Rush University Medical Center.
2016 Australian sites
John McNeil Monash University (Co-PI), Walter Abhayaratna Australian National University (ANU), Lawrie Beilin University of Western Australia, Geoffrey Donnan The Florey Institute of Neuroscience and Mental Health, Peter Gibbs Walter and Eliza Hall Institute of Medical Research, Colin Johnston Monash University, Danny Liew Monash University, Mark Nelson University of Tasmania, Chris Reid Monash University, Nigel Stocks University of Adelaide, Elsdon Storey Monash University, Andrew Tonkin Monash University, Rory Wolfe Monash University, Robyn Woods Monash University, John Zalcberg Monash University.
2014 US sites
Richard Grimm The Berman Center for Clinical Research (Co-PI), William Applegate Wake Forest University School of Medicine, Sara Espinoza UT Health Science Center, Brenda Kirpach The Berman Center for Clinical Research, Karen L Margolis HealthPartners Institute for Education & Research, Anne Murray The Berman Center for Clinical Research, Raj Shah Rush University Medical Center, Jeff Williamson Wake Forest University School of Medicine, Peter Wilson Emory Clinical Cardiovascular Research Institute, Emory University.
2014 Australian sites
John McNeil Monash University (Co-PI), Walter Abhayaratna Australian National University (ANU), Lawrie Beilin University of Western Australia, Geoffrey Donnan The Florey Institute of Neuroscience and Mental Health, Peter Gibbs Walter and Eliza Hall Institute of Medical Research, Colin Johnston Baker IDI Heart and Diabetes Institute, Danny Liew Monash University, Mark Nelson University of Tasmania, Chris Reid Monash University, Nigel Stocks University of Adelaide, Elsdon Storey Monash University, Andrew Tonkin Monash University, Rory Wolfe Monash University, Robyn Woods Monash University, John Zalcberg Monash University.
Governance
Co-Principal Investigators:
2016: John McNeil, Anne Murray 2014: John McNeil, Richard Grimm
International Steering Committee:
2016: John McNeil (Co-Chair), Anne Murray (Co-Chair), Lawrie Beilin, Andrew Chan, Jamehl Demons, Mike Ernst, Sara Espinoza, Matthew Goetz, Colin Johnston, Brenda Kirpach, Danny Liew, Karen L Margolis, Frank Meyskens, Mark Nelson, Chris Reid, Raj Shah, Elsdon Storey, Andrew Tonkin, Rory Wolfe, Robyn Woods, John Zalcberg, Barbara Radziszewska NIA, Sergei Romashkan NIA, Leslie Ford NCI, Ellen Richmond NCI, Asad Umar NCI.
2014: John McNeil (Co-Chair), Richard Grimm (Co-Chair), William Applegate, Lawrie Beilin, Sara Espinoza, Colin Johnston, Brenda Kirpach, Karen L Margolis, Mark Nelson, Anne Murray, Chris Reid, Raj Shah, Elsdon Storey, Andrew Tonkin, Jeff Williamson, Peter Wilson, Rory Wolfe, Robyn Woods, John Zalcberg, Barbara Radziszewska NIA, Judy Hannah NIA, Sergei Romashkan NIA, Leslie Ford NCI, Ellen Richmond NCI, Asad Umar NCI.
Australian Management Committee:
2016: John McNeil (Chair), Robyn Woods, (Deputy Chair), Walter Abhayaratna, Lawrie Beilin, Geoffrey Donnan, Peter Gibbs, Colin Johnston, Danny Liew, Trevor Lockett CSIRO, Mark Nelson, Chris Reid, Nigel Stocks, Elsdon Storey, Andrew Tonkin, Rory Wolfe, John Zalcberg.
2014: John McNeil (Chair), Robyn Woods (Deputy Chair), Walter Abhayaratna, Lawrie Beilin, Lynne Cobiac CSIRO, Geoffrey Donnan, Peter Gibbs, Colin Johnston Baker IDI Heart and Diabetes Institute, Danny Liew, Mark Nelson, Chris Reid, Nigel Stocks, Elsdon Storey, Andrew Tonkin, Rory Wolfe, John Zalcberg.
International Endpoint Adjudication Committees:
2016:
Dementia Panel: Raj Shah (Chair), Anne Murray, Elsdon Storey, Trevor Chong Monash University, Christine Burns The Berman Center for Clinical Research.
Cardiac Combined Panel: Andrew Tonkin (Chair), Michael Jelinek St Vincent’s Hospital Melbourne, Mobin Malik Medical College of Wisconsin.
Stroke Panel: Jeff Williamson (Chair), Geoffrey Donnan, Charles Eaton Rhode Island Hospital, Geoff Cloud Alfred Health, Donna Brauer University of Minnesota.
Clinically Significant Bleeding Panel: Erica Wood Monash University (Chair), Suzanne Satterfield The University of Tennessee Health Science Center, Karen L Margolis, Mark Polizzotto University of NSW, Elsdon Storey, Suzanne Mahady Monash University.
Cancer Panel: Peter Gibbs (Chair), Finlay Macrae, Royal Melbourne Hospital, Luz Rodriguez National Institute of Health, Andrew Haydon Monash University, John Zalcberg, Wendy Bernstein Walter Reed National Military Medical Center Hematology Oncology, Jeanne Tie Walter and Eliza Hall Institute of Medical Research, Catriona McLean Alfred Health (consultant pathologist, non-adjudicator).
Depression Adjudication Panel: Michael Berk Deakin University (Chair), Paul Fitzgerald Monash University, Anne Newman University of Pittsburgh.
Physical Disability Adjudication Panel: Anne Newman (Chair), Barbara Workman Monash University, Jamehl Demons.
Cause of Death Adjudication Panel: Mark Nelson (Co-Chair), Diane Ives, University of Pittsburgh (Co-Chair).
2014:
Dementia Panel: Raj Shah Center (Chair), Anne Murray, Elsdon Storey.
Cardiac Combined Panel: Andrew Tonkin (Chair), Richard Grimm, Michael Jelinek, Mobin Malik.
Stroke Panel: Jeff Williamson (Chair), Geoff Donnan, Charles Eaton.
Clinically Significant Bleeding Panel: Erica Wood, Mark Nelson, Diane Ives, Karen L Margolis, Suzanne Satterfield.
Cancer Panel: Peter Gibbs (Chair), Finlay Macrae, Luz Rodriguez, Joel Weissfeld.
Cause of Death Adjudication Panel: Mark Nelson (Co-Chair), Diane Ives (Co-Chair).
International Data Management Committee:
2014 – 2016: Chris Reid (Chair), Jessica Lockery Monash University (Deputy Chair), Mike Ernst, Dave Gilbertson Chronic Disease Research Group Minneapolis, Brenda Kirpach, Mark Nelson, Raj Shah, Andrew Tonkin, Rory Wolfe, Robyn Woods.
Publications, Presentations and Ancillary Studies Committee:
2016: Anne Murray (Co-Chair), Chris Reid (Co-Chair), Walter Abhayaratna, Mike Ernst, Colin Johnston, Beth Lewis University of Alabama, Danny Liew, Karen L Margolis, John McNeil, Mark Nelson, Anne Newman, Thomas Obisesan Howard University Hospital, Raj Shah, Elsdon Storey, Robyn Woods, Sharyn Fitzgerald Monash University, Barbara Radziszewska.
2014: Anne Murray (Co-Chair), Chris Reid (Co-Chair), Walter Abhayaratna, Mike Ernst, Richard Grimm, Judy Hannah, Karen L Margolis, John McNeil, Mark Nelson, Anne Newman, Raj Shah, Elsdon Storey, Robyn Woods.
Site Operation Committee
US Operations Committee
2016: The Berman Center for Clinical Research Anne Murray (Chair), Brenda Kirpach, Raj Shah.
2014: The Berman Center for Clinical Research Richard Grimm (Chair), Anne Murray, Brenda Kirpach.
Australian Operations Management Team
2014 and 2016: Monash University Carlene Britt, Sharyn Fitzgerald, Jessica Lockery, Suzanne Orchard, Ruth Trevaks.
Australian Training, Recruitment, Retention & Operations Committee (TRROC)
2016: Monash University Melbourne Chair: Suzanne Orchard. Regional Chairs: Sharyn Fitzgerald, Carlene Britt.
2014: Monash University Melbourne Chairs: Ruth Trevaks (2010-2013), Suzanne Orchard (2013-2016). Regional Chairs: Sharyn Fitzgerald (2010-2014), Carlene Britt (2014-2016).
Monitoring
US
2016: The Berman Center for Clinical Research Barb Wicklund, Brenda Kirpach.
2014: Barb Wicklund, Brenda Kirpach, Nate Tessum The Berman Center for Clinical Research, Jennifer Walker Wake Forest Baptist Medical Center, Melissa Navarro UT Health Science Center San Antonio, Emily Torgerson The Berman Center for Clinical Research, Katelyn Henneman The Berman Center for Clinical Research, Anne Bergdall Health Partners Riverside Clinic.
Australia
2016: Monash University Suzanne Orchard (Lead), Carlene Britt, Jonathan Hall, David O’Reilly, Genevieve White.
2014: Monash University Esther Apos (Lead) (2010-2013), Suzanne Orchard (Lead) (2013-2016), Jonathan Hall, Andrew McGrath, Durga Shrestha, Genevieve White, Kathleen White.
Genomics Advisory Group
Whole Genome Sequencing – Medical Genome Reference Bank (MGRB)
David Thomas Garvan Institute of Medical Research, Marcel Dinger Garvan Institute of Medical Research, Andrew Stone Garvan Institute of Medical Research, John McNeil, Robyn Woods, Paul Lacaze Monash University, Jessica Lockery, Tom Gilbert Monash University.
Mt Sinai Resilience Project
Eric Schadt Icahn Institute for Genomics and Multiscale Biology, Robert Sebra Icahn Institute for Genomics and Multiscale Biology, Paul Lacaze, John McNeil, Robyn Woods, Jessica Lockery, Tom Gilbert.
ASPREE PIs at US sites
2016 US Sites – PI Anne Murray Berman Center for Outcomes and Clinical Research, Charles Eaton Memorial Hospital of Rhode Island, Shawna Nesbitt University of Texas Southwestern Medical Center, Anupama Kottam Wayne State University, Raj Shah Rush Alzheimer’s Disease Center, Anne Newman University of Pittsburgh, Kevin Peterson University of Minnesota Phalen Village Clinic, Michael Ernst University of Iowa, Jeffery Burns University of Kansas Medical Center, Susanne Satterfield (deceased) Catherine Womack (2017) University of Tennessee, Peter Wilson Emory/VA, Jocelyn Wiggins University of Michigan, Thomas Obisesan Howard University, Elena Volpi University of Texas Medical Branch, John Aloia Winthrop University Hospital, Steven Katzman Detroit Clinical Research Center, Pricilla Pemu Morehouse School of Medicine, Gregg Pressman Albert Einstein, Christine Thorburn Palo Alto Medical Research Institute, Augusto Ochoa LSU Health Sciences Center New Orleans, Gary Burton LSU Health Sciences Center Shreveport & LSU Health Sciences Center Monroe, William Robinson III Tulane Medical Center, Darron Ferris Georgia Health Sciences University, David Hanson (Sub – I) Mary Bird Perkins – Our Lady of the Lake Cancer Center, Karen Margolis HealthPartners Riverside Clinic, Mahalakshmi Honasoge Henry Ford Health System, Sara Espinoza UT Health Science Center San Antonio and Regional Academic Health Center, Jeffry Williamson and Jamehl Demons Wake Forest University School of Medicine, Steve Anton University of Florida Department of Aging and Geriatrics, Beth Lewis University of Alabama at Birmingham, Daniel Hsia Pennington Biomedical Research Center, James Powell The Brody School of Medicine at East Carolina University.
2014 US Sites – PI Anne Murray Berman Center for Outcomes and Clinical Research, Charles Eaton Memorial Hospital of Rhode Island, Shawna Nesbitt University of Texas Southwestern Medical Center, John Flack & Brian Ference Wayne State University, Raj Shah Rush Alzheimer’s Disease Center, Anne Newman University of Pittsburgh, Kevin Peterson University of Minnesota Phalen Village Clinic, Michael Ernst University of Iowa Jeffery Burns University of Kansas Medical Center, Susanne Satterfield (deceased) University of Tennessee, Peter Wilson Emory/VA, Jocelyn Wiggins University of Michigan, Thomas Obisesan Howard University, Elena Volpi University of Texas Medical Branch, John Aloia Winthrop University Hospital, Steven Katzman Detroit Clinical Research Center, Pricilla Pemu Morehouse School of Medicine, Gregg Pressman Albert Einstein, Latha Palaniappan Palo Alto Medical Research Institute, Augusto Ochoa LSU Health Sciences Center New Orleans, Gary Burton LSU Health Sciences Center Shreveport & LSU Health Sciences Center Monroe, William Robinson III Tulane Medical Center, Daron Ferris Georgia Health Sciences University, David Hanson Mary Bird Perkins – Our Lady of the Lake Cancer Center, Karen Margolis HealthPartners Riverside Clinic, Abraham Thomas Henry Ford Health System, Sara Espinoza UT Health Science Center San Antonio and Regional Academic Health Center, Jeffry Williamson and Jamehl Demons Wake Forest University School of Medicine, Steve Anton & Marco Pahor University of Florida Department of Aging and Geriatrics, Beth Lewis University of Alabama at Birmingham, Daniel Hsia & Timothy Church Pennington Biomedical Research Center, James Powell The Brody School of Medicine at East Carolina University, Mandeep Oberoi Central Jersey Medical Research Center.
ASPREE GP Associate Investigators in Australia
Abdullah M, Abdul-Ridha S, Aboud E, Abraham A, Abraham J, Abraham K, Abrahams M, Adad S, Adams C, Africa N, Afroze S, Agarwal D, Agbarakwe C, Ah Sang W, Ahern T, Ahmad Y, Ahmad Z, Ahmed L, Ajam A, Akhter R, Akram Z, Alagarswami K, Alam M, Alavi E, Aldridge L, Alethan A, Alexander K, Alexander L, Alexopoulos M, Ali B, Ali M, Allan J, Allen C, Allen G, Allen S, Allin P, Al-Musawy R, Alpren C, Al-Tawil I, Alwyn T, Amor P, Anam T, Anderson G, Anderson L, Anderson N, Anderson P, Anderson R, Anderson-Dalheim H, Andrada E, Andre S, Andrews L, Andric A, Andric M, Ang J, Ansari A, Arakji AM, Arambeploa Y, Ark R, Arnaudon FP, Arndt PM, Aroney T, Arthurson J, Arunachalam T, Asim N, Aslam I, Assad S, Astley N, Athari M, Atkins C, Atkins M, Aufgang M, Aung K, Aurora G, Auteri S, Avergun A, Awwad A, Azad C, Azra S, Babovic A, Baig M, Baker J, Baker S, Baker T, Bakhilova N, Baldam A, Baldassa A, Baldi C, Balkwill C, Balogun O, Ban A, Banerjee P, Banning M, Bansal S, Barkas R, Barker A, Barker D, Barnes A, Barnes N, Barnetson W, Barratt I, Barrett DA, Barrett Meagan, Barrett Michelle, Barrett P, Barrett T, Barson P, Barstad C, Barton W, Bartram M, Bartusek P, Basser S, Bassett S, Batchelor L, Batt D, Batty A, Baum S, Baxter M, Beaton G, Beaumont J, Beavis D, Beckett V, Beech M, Beilby J, Bekal S, Bell A, Bendtsen L, Benedict D, Benjamin T, Bennett P, Bennie G, Bennie S, Bennison S, Benson A, Benson R, Benson S, Bergin J, Bergin S, Berryman G, Berryman J, Bertram H, Bertuch G, Bettenay G, Bettiol L, Bills R, Birch J, Bird Rachel, Bird Robert, Birks R, Blake R, Blakney A, Blashki M, Bleach G, Bloch B, Bodenstein M, Boga V, Bollen C, Boltin P, Boon B, Booth G, Borg A, Bornstein D, Bottcher C, Bourke J, Bourke M, Boutcher S, Bowden J, Bowen J, Bowring B, Boyce C, Boyd J, Brack R, Bradshaw A, Brady P, Braithwaite J, Braude G, Brayshaw N, Breen M, Bresnahan R, Briddon P, Bridge A, Briggs SJ, Brimage RF, Britten-Jones W, Brkic M, Broadby M, Bromberger D, Brommeyer A, Broom I, Brophy T, Brough J, Brougham JP, Broun C, Brown ID, Brown J, Brown MB, Brown MP, Brown R, Brownbill C, Brownbill L, Browne M, Brownstein M, Bruce A, Brunacci F, Brunner C, Bruorton M, Buccheri V, Buchanan D, Buckley J, Bulle B, Bundy K, Burke M, Busch G, Bush CP, Butrev A, Bvirakare J, Bvumbura BF, Bye J, Byrne C, Byrne P, Cain M, Calcutt I, Calder K, Caldwell M, Callan C, Cameron A, Cameron David, Cameron Donald, Cameron T, Campbell David, Campbell Donald, Campbell Geoffrey, Campbell Guy, Campbell PH, Campbell R, Carroll N, Carroll V, Carson J, Carson R, Carter L, Carter P, Carter R, Carter S, Cartwright P, Cassidy P, Catchpole M, Cato G, Celada R, Chai F, Chalabi A, Chalissery P, Chalmers ML, Chamberlain H, Chamoun R, Chan B, Chan C, Chan CK, Chan FW, Chan K, Chandran S, Chandrananth M, Chandrananth S, Chang C, Chang V, Chang W, Changakoti A, Chantler R, Chao D, Chao S, Charlton P, Chattersee A, Chau G, Chaung Y, Chawtur V, Cheah H-H, Cheah S, Cheasley A, Chee H, Chen D, Cheng W, Chesney D, Chew D, Chhabra P, Chia I, Chia P, Chiang A, Chiang S, Chiew I, Chiew L, Chikarsal A, Chin J, Chin M, Chipman JS, Chipperfield C, Chisholm H, Chisholm L, Chiu A, Chiu C, Chiu D, Chiu T, Chizik L, Choksey H, Choo E, Chow Amy, Chow Andrew, Choy C, Chu S, Chua A, Chuah T, Chung J, Cimpoescu T, Clapton J, Clark Benedict, Clark Benjamin, Clark M, Clark R, Clarke A, Clarke D, Clarke S, Cleary G, Clerigo L, Clohesy S, Close S, Cochrane F, Cohen IS, Cohen J, Colahan R, Collins J, Colman W, Colvin R, Conde S, Connell P, Connellan M, Connor W, Connors G, Conos M, Conron D, Conroy J, Conway C, Cooper M, Cooper S, Cope A, Corrigan Simon, Corrigan Sue, Coughlan P, Coulter E, Counsel L, Court D, Courtis G, Cousens A, Craig L, Crameri M, Cranswick M, Crawford J, Crawford M, Crawford P, Crawford R, Crick S, Crimmins B, Cristofaro R, Croatto J, Crompton A, Cronin E, Crookes J, Cross B, Cross D, Cross M, Crow P, Crowe JE, Crowe P, Crowley H, Cruickshank J, Cummins R, Cunneen A, Cunningham A, Cunningham N, Cunningham P, Curnow D, Curran J, Curran M, Currie A, Curtis R, Cusack J, Dabash K, Dabestani V, Dadabhay Z, Daglas D, Dagley P, Danesh S, Dang D, Daniels R, Darby JP, Darko N, Darling J, Darlington B, Das J, Das P, Date M, Datta C, Datta S, Davenport C, Davey G, Davey M, Davey P, Davidson CL, Davidson D, Davies M, Davies-Hakeem A, Davis G, Davis K, Davis Paul, Davis Peter, Davis S, Dawe N, Dawes R, Dawkins P, Dawson G, Dawson P, Dawson R, Day P, Daya M, Dayasagar D, D’Costa L, De Clifford M, De Gleria S, De Poi C, De Silva M, De Silva P, De Steiger R, De Villiers D, De Wit E, Debnath R, Deery R, DeL anerolle D, Del Rio F, Delaney S, Delitzsch SS, Demaio F, Demian M, Demirtzoglou J, Denton T, Derrick L, Deshmukh K, Dessauer J, Devavittiya C, Devereux D, Dewan D, Dewhurst H, Dhar A, Dhillon D, Di Carlo M, Di Dio A, Di Marco A, Dickman J, Dillon L, Dinh Q-T, Dissanayake D, Dissanayake M, Dissanayake T, Divakaran K, Dixit U, Dixon H, Dixon N, Djakic E, Dobson C, Dodd L, Dodds P, Dodic A, Dodic M, Doley A, Dolguina S, Dolling C, Donaghy F, Donald H, Donelan E, Donohue M, Dooland J, Dooley H, Doslo S, Douglas A, Dover P, Downe G, Drake P, Dry D, Duane P, Dubash A, Dubetz D, Duff P, Duke R, Dumitrescu C, Dunbar A, Dunbar S, Dunn S, Duong NH, Dutta N, Dutton M, Duval A, Dyson-Berry J, Eade P, Eaton D, Ebert K, Edib K, Edillo E, Edmonds J, Edwards F, Edwards PA, Edwards S, Eftekharuddin M, Egan A, Egan P, Ehrenreich S, Ehsan E, Elberg L, Elisha B, Elisha R, Elkhoury H, Ellerton K, Elliot-Smith A, Elmore R, Elshenawy I, Elsherif S, Elsouki M, Elton P, Emmerson M, Emmett SI, English J, Enten P, Entwistle J, Epa W, Erhardt A, Etta J, Evans M, Everitt T, Ewing J, Fahkok B, Faigen M, Fair A, Fairbrother C, Fanning J, Fantasia M, Farag E, Fardell K, Farrant J, Farrell P, Farrow J, Fassett M, Faull PA, Ferguson P, Fernando Sujeewa, Fernando Sumudu, Ferruccio A, Fidge JH, Field P, Figurireo L, Fisher H, Fisher J, Fitzgerald E, Fitzgerald M, Fitzgerald R, Fitzpatrick H, Fitzpatrick J, Fitzpatrick P, Fitzpatrick T, Flaherty P, Flanagan D, Flanagan T, Flew S, Fonseka PP, Foo J, Foo S, Foo Y, Foong E, Ford D, Foster D, Fourlanos V, Fowler I, Fox D, Fox F, Fox M, Fox P, Fox-Smith D, Francis J, Francis R, Frank O, Franks A, Fredericks A, Freeman E, French L, Frew B, Friebel D, Friebel T, Frost S, Fryer D, Fuller J, Fung W, Fung WP, Furphy S, Gabutina C, Gaggin S, Galbraith S, Gale M, Gall J, Gallichio V, Gangell AW, Garde MA, Gardner SS, Gardner T, Garland J, Garra G, Garrow S, Garvey J, Gauden M, Gault A, Gaur D, Gavralas A, George N, George S, Georgy M, Gerendasi R, Geschke H, Giannakakis J, Gidley G, Gilani M, Giles P, Gill K, Gill P, Gill R, Gillis C, Gilmore A, Gilovitz M, Gingold R, Glaspole D, Glowinski L, Glue AL, Godakumbura P, Godavarthy R, Goel A, Goeltom C, Goldberg E, Goldberg J, Golets M, Gong V, Goode J, Goodman C, Goodwin RJ, Gopathy S, Gordon M, Gough S, Govender M, Gow K, Gowrie B, Goy P, Grabowski C, Graddon J, Granek A, Gray JM, Gray M, Gray T, Grbac E, Greacen J, Greculescu E, Green J, Greenwood E, Griffin E, Griffith V, Griffiths A, Griffiths G, Griffiths J, Griffiths K, Grigorian AR, Grinzi P, Grogan H, Grokop G, Grossman L, Grove A, Gruzauskas A, Gu M, Guest S, Guindi N, Guo H, Gurney R, Guy J, Guymer J, Gwynn R, Gyorki J, Habibi S, Hachem C, Hackett A, Hackett J, Haddad J, Haddad M, Hadley E, Hagger R, Haider Z, Hain R, Hajicosta T, Hales P, Hall J, Hall P, Hall Robert, Hall Roslyn, Hall S, Halliburton K, Halliday A, Halliday B, Halliday J, Hamblen K, Hamel J, Hamer I, Hamilton J, Hamilton RF, Hammond T, Hanbury R, Hancock A, Hand R, Hanna A, Hanna M, Hanna S, Hanson G, Hanson PD, Haque E, Haran C, Haran T, Hare WJ, Harewood A, Haripersad S, Harman A, Harmer D, Harms P, Harnden C, Harrington M, Harris A, Harris M, Harrison M, Harrison S, Hart E, Hartley D, Hartley P, Hartnett M, Harvey C, Haslam K, Hassani I, Hassett RB, Hastings W, Hattingh A, Hawke I, Hawkins C, Hayes V, Heale J, Healy G, Hebblewhite A, Hechtman A, Hedgland A, Heffernan C, Heikkinen MN, Heinrich C, Henderson J, Henry F, Herath S, Herbert A, Herbst D, Hermiz S, Herrman J, Hesse M, Hetherington J, Hetzel R, Hewett R, Hides R, Higgins CD, Hildred S, Hill A, Hilton C, Hince R, Hines C, Hinton C, Hipolito A, Ho CK, Ho L, Hoar J, Hocking L, Hodge A, Hodgkins A, Hodgson J, Hogbin J, Hok S, Holder B, Holland D, Holland M, Hollins B, Homewood M, Hong Zhou A, Honig J, Honigman S, Hookham D, Hooper W, Hope L, Horman J, Horng T, Hornstein I, Horriat M, Horvat J, Hossain M, Hough P, Howe J, Howson W, Hubczenko I, Hubel M, Hughes J, Hughes P, Hunter D, Huq S, Hussain A, Hutchins I, Hutchinson A, Hyam P, Hyare K, Iakovidis B, Ibragimov M, Idris M, Ierace C, Ikladios A, Imgraben P, Ingham C, Ip A, Ip Y, Iqbal A, Iqbal M, Irvine G, Irwin V, Iser D, Islam N, Islam S, Isles JK, Ismail A, Ivanoff G, Iwe N, Jackett RB, Jackson M, Jackson N, Jackson P, Jackson T, Jacoup M, Jaensch E, Jain P, Jain S, Jaiswal N, Jaksic A, Jakubowicz I, Jamel B, James J, Jameson D, Jansz C, Jarman E, Jassi I, Jayasinghe S, Jayatilake J, Jayaweera V, Jeanes R, Jeanneret CI, Jedynak S, Jeffries L, Jegadeesh K, Jenkins P, Jennings C, Jenny C, Jiang YY, Jigau C, Jinadasa C, Joel S, John R, Johns P, Johnson C, Johnson J, Johnson M, Johnson N, Johnson W, Johnston B, Johnston K, Johnston M, Johnston R, Johnston T, Jones G, Jones I, Jones L, Jones M, Jones S, Jones Tania, Jones Tudor, Joshi M, Joshi Naveen, Joshi Nirupama, Joske F, Joubert C, Jovanovic B, Joyce R, Judd AM, Judd J, Kaaden JP, Kabat L, Kabourakis F, Kaippilly A, Kajani H, Kamale A, Kaminsky L, Kanapathipillai U, Kanashuk L, Kao R, Kapadia P, Kapadia V, Karmouche R, Kaur KJ, Kavanagh T, Kay A, Kay B, Kaye S, Keane K, Keating B, Keecha E, Keecha J, Keenan P, Keillar P, Kemp G, Kemp P, Kennedy M, Kennedy U, Kennett S, Kesarapu S, Khan F, Khan I, Khan M, Khong CK, Khoo F, Khoo J, Khoo S, Khoshghalb A, Kiefer J, Kiley M, Kilov G, Kimpton N, King SC, Kingston R, Kinsella P, Kipouridis A, Kirwan A, Kisselev S, Kitchen J, Kloot S, Knaggs J, Knight E, Knobel J, Knowles D, Knowles P, Kogosowski S, Kok Jereth, Kok Joyce, Kollios D, Konopnicki H, Koravos A, Korol P, Kosky AR, Kote Somashekarappa M, Kottegoda-Vithana E, Kotur S, Kozminsky M, Kraner G, Kraus DH, Krell I, Kruytbosch C, Kuay V, Kucminska A, Kulatunga P, Kulinski M, Kumar J, Kumar R, Kumar S, Kumarage D, Kumaraswamy S, Kunze M, Kurien S, Kuruvilla P, Kwong R, Kyaw Z, Kyriacopoulos J, Lackner PJ, Lahanis C, Lajoie D, Lajoie K, Lakshmanan A, Lal A, Lalor E, Lam D, Lambooij C, Lancaster M, Landa L, Landers J, Lane R, Langston K, Lapin S, Lath P, Lau-Gooey T, Lawlor-Smith L, Le Couteur S, Le P, Le Riche M, Le V, Le W, Leber D, Ledner A, Lee B, Lee C, Lee D, Lee FB, Lee Jade, Lee James, Lee Jessicasu-Yin, Lee John, Lees K, Lees R, Lees W, Leffler P, Lenton J, Leong R, Leow L, Leow P, Leow Y, Leslie N, Lester SE, Lewi L, Lewis P, Lewis R, Li A, Li J, Liang J, Liang Xs, Libhaber H, Lichtblau B, Lickiss T, Liedvogel M, Liew K, Light L, Lightfoot W, Lim C, Lim D, Lim H, Lim HS, Lim J, Lim SG, Limaye S, Limbu Y, Lindenmayer J, Lindstedt P, Lines A, Ling J, Ling R, Linton J, Linton S, Linton T, Liow C, Liow YC, Lip L, Lipson D, Liu S, Liu Y, Liubinas R, Liveriadis T, Lizner S, Lloyd M, Lo B, Lo C, Lock P, Lockhart M, Logan M, Loke KP, Long Matthew, Long Michael, Longworth W, Loo KH, Lopez-Hernandez S, Lord RJ, Louw J, Louw TT, Low B, Low F, Lowe M, Lowther D, Loxley P, Lu P, Lu S, Lucarelli A, Lui G, Lui K, Lui R, Luke C, Lukic N, Lupton J, Luscombe T, Luttrell CL, Lyall A, Lynch J, Lynn K, Lyon D, Lyon E, Lyons S, Macaulay G, Macaulay K, MacIndoe A, MacIsaac P, Maciver R, Mackay B, Mackay J, Mackinnon D, Mackle R, Macphail J, Madawala N, Madden J, Madeley C, Madhanpall N, Magarey J, Magill M, Mah S, Mahadeva SP, Mahendran S, Maher J, Maher M, Mahmood Aamir, Mahmood Abbas, Maier K, Majchrzak W, Majeed J, Makar A, Makohon R, Malcher P, Malcolm HE, Malcolm M, Mallett S, Mallik A, Manderson J, Mane S, Mangan G, Manifold M, Manoliadis M, Manovel B, Mansour A, Manton D, Marano F, Marchant D, Mariajoseph G, Marinos A, Marinucci D, Marrows M, Marsh D, Martin C, Martin G, Martin R, Marton F, Martynova L, Mason N, Masood U, Massaud M, Massy-Westropp P, Masters B, Mather J, Mathews RA, Mathieson G, Mauro M, Mauviel PA, Maxfield N, Mayhead C, Mazengiya S, Mazhar A, Mbachilin G, McAllan A, McCallum H, McCann N, McCarthy A, McCleary A, McClelland R, McConville DS, McCorkell J, McCormack G, McCormick H, McCowan M, McCutcheon J, McDonald AG, McDonald AS, McDonald IR, McDonald J, McDonald N, McDonald S, McEniery A, McEntee K, McGee R, McGinity P, McGowan N, McGowan R, McGrath L, McGuire Paul, McGuire Precious, McHardy C, McHenry K, McIllree R, McKay M, McKellar C, McKelvie M, McKenzie SI, McKeown J, McKeown M, McKernan S, McKinnon A, McLaren G, McLeod I, McMahon A, McMaster I, McNab NR, McNaughton EL, McNiff M, McPherson C, Meaney J, Medlicott M, Medres R, Megally R, Mehta K, Mellios O, Melvani R, Mencel J, Mendick S, Mendis L, Menzies J, Mercado M, Mesiha S, Meyer PL, Meyer R, Miceli A, Michaelson T, Michail A, Michelmore K, Miezis V, Milan S, Milky S, Miller K, Milner J, Milone R, Milton C, Milward N, Mirhom R, Mirranay S, Mishricky H, Misso R, Mitchell A, Mitchell D, Mitchell L, Mobilia G, Moffitt M, Mohr V, Moller Gary, Moller Graeme, Molloy P, Molloy T, Molyneux P, Monaghan C, Monash D, Moncrieff S, Monzon M, Mooney T, Moore E, Moran J, Morgan G, Morgan M, Morgan N, Morris N, Morris S, Morrison H, Morrow S, Morton R, Moschou C, Moulding S, Moule V, Mouzakis V, Mudunna D, Mudzi S, Mulkearns P, Mullen D, Mulvey G, Mungi D, Munro L, Muraledaran S, Murphy B, Murphy G, Murray A, Murray B, Murray E, Murray H, Murray S, Murtagh C, Nadarajah M, Naiker S, Naing W, Nandha R, Nankervis J, Naoum A, Nash C, Nashed M, Nasreen N, Nath-Chand U, Neagle M, Nelson C, Nelson MR, Nesbitt P, Neuberger M, Newman S, Newton S, Ng D, Ng H, Ng S, Nguyen D, Nguyen HQ, Nguyen HT, Nguyen T, 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The Data Safety and Monitoring Board (DSMB) was appointed by the NIA (the major funding body for the trial). The DSMB has responsibility for monitoring quality control of the data, progress of recruitment and safety aspects of the trial. Reports are provided to the DSMB every six months regarding the progress of the trial with a focus on recruitment, retention of participants, event rate tracking and adverse event monitoring. The DSMB provides a follow-up report and recommendations to the NIA and the ASPREE Steering Committee on these issues.
The International Data Management Committee (IDMC) meets monthly to monitor the ASPREE data management processes in Australia and the USA. The IDMC reviews data reports generated by the Data Management Committee (DMC) and quality assurance reports for the study. The IDMC Chair reports to the ISC on data management issues associated with the study.
The International Endpoint Adjudication Committee (EAC) evaluates ASPREE participant outcomes while still blinded to randomised treatment. Each study endpoint is validated through examination of relevant clinical records. Specialist sub-committees have been appointed, including the Dementia Panel, the Cancer Panel, the Cardiovascular Panel and the Clinically Significant Bleeding Panel to adjudicate on specific endpoint outcomes.
The purpose of the review of sub-study proposals is to ensure the integrity of the principal ASPREE study is not compromised, that participant burden is not excessive and the scientific questions are relevant to ASPREE. The purpose of the review and oversight of publications is to ensure timely and high-quality publication of findings from ASPREE and to encourage broad and equitable participation by ASPREE investigators in presenting and publishing the results.
The US Operations Committee is responsible for the finer details of implementing the study, monitoring progress ensuring adherence and standardisation throughout the 4 hubs and 34 sites in the USA. This committee ensures quality control review of laboratory data, clinical measurements and data collection, completeness of data and transfer of data to the Data Management Centre, site monitoring and appropriate source documentation. The US Operations Committee reports to the IOC.
The US Recruitment & Retention Committee is made up of representatives from each of the 34 clinical sites in the USA and is responsible for recruiting participants into ASPREE and ensuring that they remain an active participant throughout the course of the study.
The Data Management Committee (DMC) is responsible for establishing the web-based data systems for participant and GP data, overseeing programming and changes to the databases and day-to-day management of the databases and systems of data collection. The DMC prepares reports and interrogates the database to respond to queries from study investigators and managers, in addition to resolving issues relating to data capture and the database. It also reviews the reports from the databases, the rates of adherence to randomised treatments and the data from the quality assurance program and reports to the IDMC.
The Australian Management Committee (AMC) is responsible for the Australian aspect of implementing the study, monitoring the progress of recruitment and ensuring adherence and standardisation across the sites. This committee ensures quality control review of laboratory data, clinical measurements and data collection, completeness of data and transfer of data to the Data Management Centre, site monitoring and appropriate source documentation.
The Training, Recruitment, Retention and Operations Committee (TRROC – Australia) monitors and manages the day to day operations of Australian field staff, ensuring compliance with the study protocol and objectives. The committee keeps study staff up to date on study procedures and provides instruction and refresher training on all aspects of the protocol for the main study. The TRROC meets bi-monthly, with one meeting focussed on Melbourne and the other meeting focussed on all sites outside the Melbourne area.
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