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Karen Hayden

Operational Director of the Clinical Trials Unit
Faculty of Health, Medicine and Social Care
School of Medicine
Areas of Expertise:
Clinical trials

Karen has expertise in building data management and randomisation systems, budget management and project development for a variety of types of clinical trials.

[email protected]


Karen started her role as Clinical Trials Data Manager within the newly established Anglia Ruskin Clinical Trials Unit in March 2012 which included working with clinicians throughout every stage from bid development to publication to ensure data is captured and reported in accordance with regulatory requirements to produce high quality research. In 2019, she took on the role of Operational Director for the unit and leads on all aspects of the trial life cycle. Her work has also included a number of evaluations within the health care settings.

Previously she worked in the NHS as the Senior Data Manager within the Research and Development Department at Basildon University Hospital. Her role her involved data management and financial accountability of NIHR portfolio, commercial and non-commercial studies.

Research interests
  • Clinical trials
  • Clinical evaluations
  • Research
  • Ethics

Karen has worked on a number of studies and evaluation throughout healthcare, in particular working in the areas of prostate cancer, venous ulceration, chronic kidney disease, gout, dry eye, dementia, cancer care and allied health professions. These studies have been funded through various awards including NIHR, European Commission and Industry funding.

  • MSc Psychological Research Methods, The Open University
  • BSc (Hons) Psychology, The University of Kent
Selected recent publications

Choudhury, M., Shibu Thomas, S., Cain, A.,  Palvai, S.,  Nageshwaran, S., Zhang, J.,  Hayden, K., Cain, A., Hoskin, P.,  Ahmed, I., 2023. Timing of High-Dose Rate Brachytherapy With External Beam Radiotherapy in intermediate and High-Risk Localized Prostate CAncer (THEPCA) A Randomised Trial. International Journal of Radiation Oncology*Biology*Physics, 12.

Milton. C., Creese, J.,  Burrows, K., Moore, C., Hayden, K.,  Kemp, E.,  Johnson, J., 2023. Cytokine Storm Biomarkers and clinical presentation in children presenting with PIMS-TS - an observational cohort study. British Paediatric Allergy Immunity and Infection Group, 7.

Balasubramaniam, G., Almond, M., Harnett, P., Zhang, J., Turner, D., Scales, J., Moore, C., Hayden, K., Roddy, E., Mallen, C., Ng, N., Bhagat, S., Rutherford, A., Dasgupta, B., 2023. A Randomised controlled trial comparing anakinra versus steroids for the treatment of gout attacks for people with renal disease (ASGARD): A feasibility study. Annals of the Rheumatic Diseases, 6.

Stather, P., Petty, C., Langthorne, H., Rayner, E., Zhang, J., Hayden, K., Howard, A., 2021. A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the JuxtaCuresTM device in the management of people with venous ulceration: Feasibility study. Phlebology, 0(0) pp 1-10

Zhang, J., Hayden, K., Jackson, R., Schutte, R., 2020, Association of red and processed meat consumption with cardiovascular morbidity and mortality in participants with and without obesity: A prospective cohort study. Clinical Nutrition.

Zhang, J., Hayden, K., Jackson, R., Schutte, R., 2020, Associations of weight changes with all-cause, cancer and cardiovascular mortality: A prospective cohort study. Public Health in Practice, 2, 100065

Balal, S., Udoh, A., Pappas, Y., Cook, E., Barton, G., Hassan, A., Hayden, K., Bourne, R., Ahmad, S., Pardhan, S., Harrison, M., Sharma, B., Wasil, M., Sharma. A., 2018 The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial. BMJ Open, 8(10).

Palvai, S., , Harrison, M., Shibu Thomas, S., , Hayden, K., Green, J., Anderson, O., Romero, L., Lodge, R., Burns, P., Ahmed, I., 2015. Timing of High-Dose Rate Brachytherapy With External Beam Radiotherapy in intermediate and High-Risk Localized Prostate CAncer (THEPCA) Patients and its Effects on Toxicity and Quality of Life: Protocol of a Randomized Feasibility Trial. JMIR Research Protocols, 4(2) e49.