Pollyanna Hardy is Clinical Trialist and Director of the National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU CTU).
Polly graduated from the University of Sussex in 1990 with a BSc in Mathematics and European Studies, and obtained an MSc in Statistics from University of Sheffield in 1994. She has previously worked as a medical statistician at the London School of Hygiene and Tropical Medicine and the Murdoch Children's Research Institute in Melbourne, Australia. Polly joined the NPEU CTU as a Senior Statistician in 2010. In 2017 she then took up a post as a Statistics Lead at the Birmingham Clinical Trials Unit, University of Birmingham, where she spent four years working on a diverse portfolio of Randomised Controlled Trials (RCT), including perinatology, global surgery, mental health and health services delivery. She then returned to the NPEU in 2021 as Director of the CTU.
Polly has extensive experience in the design, conduct, analysis and reporting of RCTs, with a keen interest in complex RCT design methodology, and has particular expertise in RCTs in the field of obstetrics and neonatology. She is the statistics lead for the National Institute for Health Research Global Health Research Unit on Global Surgery RCT portfolio, and a member of a national Steering Group to develop a set of principles for handling end of follow-up events in clinical trials research (PeRSEVERE). She also currently sits on the NIHR Health Technology Assessment Commissioning Board.
Birthplace in England Collaborative Group, Brocklehurst P, Hardy P, Hollowell J, Linsell L, Macfarlane A, McCourt C, Marlow N, Miller A, Newburn M, Petrou S, Puddicombe D, Redshaw M, Rowe R, Sandall J, Silverton L, Stewart M. Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study. British Medical Journal. 2011;343. http://www.bmj.com/content/343/bmj.d7400
Hollowell J, Puddicombe D, Rowe R, Linsell L, Hardy P, Stewart M, Redshaw M, Newburn M, McCourt C, Sandall J, Macfarlane A, Silverton L, Brocklehurst P, Birthplace in England Collaborative Group obo. The Birthplace national prospective cohort study: perinatal and maternal outcomes by planned place of birth. Birthplace in England research programme. Final report part 4: NIHR Service Delivery and Organisation programme. 2011. http://www.netscc.ac.uk/hsdr/files/project/SDO_FR4_08-1604-140_V03.pdf
Group CC, Abalos E, Oyarzun E, Addo V, Sharma JB, Matthews J, Oyieke J, Masood SN, El Sheikh MA, Brocklehurst P, Farrell B, Gray S, Hardy P, Jamieson N, Juszczak E, Spark P. CORONIS - International study of caesarean section surgical techniques: the follow-up study. BMC Pregnancy Childbirth. 2013;13:215. http://www.ncbi.nlm.nih.gov/pubmed/24261693
The CORONIS Collaborative Group, Ablos E, Addo V, Brocklehurst P, El Sheikh M, Farrell B, Gray S, Hardy P, Juszczak E, Mathews JE, Masood SN, Oyarzun E, Oyieke J, Sharma JB, Spark P. Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial. The Lancet. 2013;382(9888):234-48. http://www.ncbi.nlm.nih.gov/pubmed/23721753
Costeloe K, Hardy P, Juszczak E, Wilks M, Millar MR, Probiotics in Preterm Infants Study Collaborative G. Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial. Lancet. 2016;387(10019):649-60. http://www.ncbi.nlm.nih.gov/pubmed/26628328
Costeloe KL, Bowler U, Brocklehurst P, Hardy P, Heal P, Juszczak E, King A, Panton N, Stacey F, Whiley A, Wilks M, Millar MR. A randomised controlled trial of the probiotic Bifidobacterium breve BBG-001 in preterm babies to prevent sepsis, necrotising enterocolitis and death: the Probiotics in Preterm infants (PiPS) trial. Health Technol Assess. 2016;20(66). http://journalslibrary.nihr.ac.uk/hta/hta20660
Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. The Lancet. 2016;387(10015):239-50. http://www.ncbi.nlm.nih.gov/pubmed/26507180
Hardy P, Bell JL, Brocklehurst P. Evaluation of the effects of an offer of a monetary incentive on the rate of questionnaire return during follow-up of a clinical trial: a randomised study within a trial. BMC Medical Research Methodology. [journal article]. 2016;16(1):82. http://dx.doi.org/10.1186/s12874-016-0180-9
Edwards AD, Redshaw ME, Kennea N, Rivero-Arias O, Gonzales-Cinca N, Nongena P, Ederies M, Falconer S, Chew A, Omar O, Hardy P, Harvey ME, Eddama O, Hayward N, Wurie J, Azzopardi D, Rutherford MA, Counsell S. Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation. Archives of Disease in Childhood - Fetal and Neonatal Edition. 2017;103(1):F15-F21. https://www.ncbi.nlm.nih.gov/pubmed/28988160
Millar M, Seale J, Greenland M, Hardy P, Juszczak E, Wilks M, Panton N, Costeloe K, Wade WG. The Microbiome of Infants Recruited to a Randomised Placebo-controlled Probiotic Trial (PiPS Trial). EBioMedicine. 2017;20:255-62. https://www.ncbi.nlm.nih.gov/pubmed/28571671
Bick D, Briley A, Brocklehurst P, Hardy P, Juszczak E, Lynch L, MacArthur C, Moore P, Nolan M, Rivero-Arias O, Sanders J, Shennan A, Wilson M. A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: clinical effectiveness and an economic evaluation (BUMPES). 2017 Contract No.: 65. https://www.ncbi.nlm.nih.gov/pubmed/29110753
Chappell LC, Chambers J, Dixon PH, Dorling J, Hunter R, Bell JL, Bowler U, Hardy P, Juszczak E, Linsell L, Rounding C, Smith A, Williamson C, Thornton JG. Ursodeoxycholic acid versus placebo in the treatment of women with intrahepatic cholestasis of pregnancy (ICP) to improve perinatal outcomes: protocol for a randomised controlled trial (PITCHES). Trials. [journal article]. 2018;19(1):657. https://doi.org/10.1186/s13063-018-3018-4
Chappell LC, Brocklehurst P, Green ME, Hunter R, Hardy P, Juszczak E, Linsell L, Chiocchia V, Greenland M, Placzek A, Townend J, Marlow N, Sandall J, Shennan A, Group PS. Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. Lancet. 2019;394(10204):1181-90. https://www.ncbi.nlm.nih.gov/pubmed/31472930
Chappell LC, Green M, Marlow N, Sandall J, Hunter R, Robson S, Bowler U, Chiocchia V, Hardy P, Juszczak E, Linsell L, Placzek A, Brocklehurst P, Shennan A. Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial). Trials. 2019;20(1):85. https://doi.org/10.1186/s13063-018-3150-1
Maheshwari A, Bhattacharya S, Bowler U, Brison D, Child T, Cole C, Coomarasamy A, Cutting R, Harbottle S, Hardy P, Juszczak E, Khalaf Y, Kurinczuk JJ, Lavery S, Lewis-Jones C, Macklon N, Raine-Fenning NJ, Rajkohwa M, Scotland G, Troup S. Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation. Reproductive Health. [journal article]. 2019;16(1):81. https://doi.org/10.1186/s12978-019-0737-2
Yates H, Chiocchia V, Linsell L, Orsi N, Juszczak E, Johnson K, Chetcuti P, Illingworth C, Hardy P, Monk V, Newell S, Turner M. Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT. Southampton (UK): NIHR Journals Library, Efficacy and Mechanism Evaluation. 2019 Contract No.: 8. https://www.ncbi.nlm.nih.gov/books/NBK545805/ doi: 10.3310/eme06080
Bell JL, Hardy P, Greenland M, Juszczak E, Cole C, Maheshwari A, Bhattacharya S, Linsell L. E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan. Trials. 2020;21(1):596. https://doi.org/10.1186/s13063-020-04441-9
Bell JL, Gupta S, Juszczak E, Hardy P, Linsell L. Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes. Trials. 2021;22(1):368. https://doi.org/10.1186/s13063-021-05324-3
Gupta S, Juszczak E, Hardy P, Subhedar N, Wyllie J, Kelsall W, Sinha S, Johnson S, Roberts T, Hutchison E, Pepperell J, Linsell L, Bell JL, Stanbury K, Laube M, Edwards C, Field D, on behalf of the The Baby Oscar Collaborative Group. Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial. BMC Pediatrics. 2021;21(1):100. https://doi.org/10.1186/s12887-021-02558-7