Clinigma| Caroline Wilson (PhD)

Caroline Wilson (PhD)

Senior Research Associate

Role

Degree

DPhil, Medical Anthropology

Personal Info

cw@clinigma.com

About

Caroline brings over 15 years of specialized expertise in qualitative research methodology and clinical trial design to CLINIGMA^®. As Senior Research Associate, she leverages her extensive academic background and practical experience to develop comprehensive interview strategies that deliver robust evidence for pharmaceutical development programs.

Expertise

Clinical Trial Research Excellence

Over 8 years as Senior Research Associate at Bristol Medical School specializing in qualitative research within randomized controlled trials
Clinical Trial Manager experience overseeing two CTIMPs across 45+ hospital sites
Expert in improving trial conduct, recruitment, and informed consent through qualitative research integration
Proven track record working across diverse medical specialties including oncology, orthopedics, anesthesia, renal, urology, ENT, and gastroenterology

Advanced Academic Qualifications

DPhil in Medical Anthropology from University of Sussex with specialized focus on healthcare systems and patient experience
MSc in Social Research Methods providing robust foundation in qualitative and quantitative research design
MA in Anthropology of Development with deep understanding of cross-cultural research approaches

Patient-Focused Drug Development Expertise

Specialist in ICH-GCP semi-structured in-trial interviews using concept elicitation, cognitive debrief, and treatment experience methodologies
Expert in developing interview manuals and conducting literature reviews for pharmaceutical companies
Proven ability to shape patient experience research into conceptual disease models, COA strategy, and clinical endpoints
Deep understanding of FDA Patient-Focused Drug Development requirements and meaningful change assessment

Qualitative Research Leadership

Active member of MRC ConDuCT-II Hub with broad understanding of complex trial methodology
Regular reviewer of NIHR-funded grants and trials methodology journal articles
Specialist in including patient and family perspectives in clinical research with experience establishing PPI groups

Implementation Science and Health Services Research

Research Fellow experience in process evaluations and mixed methods studies for healthcare interventions
Specialist expertise in understanding how to implement health policies and improve service provision
Author of comprehensive health profiles analyzing social, cultural, political, economic, and ecological determinants of health

Regulatory Compliance and Quality Management

Extensive experience ensuring compliance with sponsor, funder, GCP, and regulatory requirements
Proven track record managing clinical trials to agreed recruitment timelines and budgets

Publication and Scientific Communication

Extensive publication record in high-impact journals including Trials, British Journal of Urology International, and PLOS Medicine
Regular presenter at academic conferences and professional meetings
Proven ability to translate research findings into policy recommendations and practice improvements
Expert in developing comprehensive research dissemination strategies

Caroline's unique combination of advanced academic training, extensive clinical trial experience, and deep understanding of patient-centered research methodologies ensures that CLINIGMA®'s interview studies are designed and executed to the highest scientific standards.

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Publications

The By-Band-Sleeve Collaborative Group 2025 Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity (By-Band-Sleeve): a multicentre, open label, three-group, randomised controlled trial, Lancet Diabetes Endocrinol; 13: 410–26.

Lloyd KE, Wilson C et al. 2025 Healthcare professionals' and patients' views and experiences of surgical and medical treatment for nasal obstruction: a qualitative interview study for a Nasal Airway Obstruction Study (NAIROS). BMJ Open. 2025 Jun 8;15(6):e099395. doi: 10.1136/bmjopen-2025-099395. PMID: 40484431; PMCID: PMC12161377.

McEvoy D, Wilson C, et al. Identifying personally modifiable factors for self-harm recovery in young people: A protocol for a systematic review HRB Open Res 2025, 8:48 https://doi.org/10.12688/hrbopenres.14123.1

Gallant AJ et al. 2025 Mapping barriers, enablers and implementation determinants to shared models of care for physical health and sexual wellbeing among young people with mental health difficulties using the Consolidated Framework for Implementation Research: A scoping review protocol [version 1; peer review: 2 approved with reservations]. HRB Open Res 2025, 8:28https://doi.org/10.12688/hrbopenres.14032.1)

Sooriakumaran, PS, Wilson C et al. 2021 Feasibility and safety of radical prostatectomy for Oligo-metastatic prostate cancer: the Testing Radical prostatectomy in men with prostate cancer and oligo‐Metastases to the bone (TRoMbone) trial), British Journal of Urology International. BJU Int 2021 doi:10.1111/bju.15669.

Birtle, A. et al. 2020 Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. The Lancet, Volume 395, Issue 10232, 1268 – 1277.

Wilson C, Armstrong A et al. 2020. Regional anaesthesia practice for arteriovenous fistula formation surgery, Anaesthesia 2020, 75, 626–633. doi:10.1111/anae.14983.

Wilson, C et al. 2018. Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework. Trials2018:19:50. DOI: 10.1186/s13063-017-2413-6.

Jepson M et al. 2018. An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment. J Clin Epidemiol. 2018 Jul;99:75-83. doi: 10.1016/j.jclinepi.2018.02.018.

Beard DJ et al. 2018. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet.2018 Jan 27;391(10118):329-338. doi: 10.1016/S0140-6736(17)32457-1.

Strong S et al. 2016 'The trial is owned by the team, not by an individual': a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology. Trials. 2016 Apr 26;17(1):212. doi: 10.1186/s13063-016-1341-1.

Donovan JL et al. 2016 Optimising recruitment and informed consent in randomized controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials. 2016 Jun 8;17(1):283. doi: 10.1186/s13063-016-1391-4..

Rooshenas L et al. 2016. Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians' Practices across Six Randomised Controlled Trials. PLoS Med. 2016 Oct 18;13(10):e1002147. doi: 10.1371/journal.pmed.1002147.

Paramasivan S et al. 2017 Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study. Int J Obes (Lond). 2017 Nov;41(11):1654-1661. doi: 10.1038/ijo.2017.153. Epub 2017 Jul 3. PMID: 28669987; PMCID: PMC5633070.

Beard D et al. 2015. The CSAW Study (Can Shoulder Arthroscopy Work?) - a placebo controlled surgical intervention trial assessing the clinical and cost effectiveness of arthroscopic subacromial decompression for shoulder pain: study protocol for a randomised controlled trial. Trials. 2015 May 9;16:210. doi: 10.1186/s13063-015-0725-y. PMID: 25956385; PMCID: PMC4443660.

Coope C, Donovan J, Wilson C, et al. 2015. Characteristics of people dying by suicide after job loss, financial difficulties and other economic stressors during a period of recession (2010-2011): A review of coroners׳ records. J Affect Disord. 2015 Sep 1;183:98-105. doi: 10.1016/j.jad.2015.04.045. Epub 2015 May 4. PMID: 26001669.

Paramasivan S et al. 2015. A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing. Trials 16, 88 (2015). https://doi.org/10.1186/s13063-015-0617-1.

Blazeby J et al. 2014. Feasibility RCT of definitive chemoradiotherapy or chemotherapy and surgery for oesophageal squamous cell cancer. Br J Cancer 111, 234–240 (2014). https://doi.org/10.1038/bjc.2014.313.

Wilson, C et al. 2014 Building an Engaged Future for UK Higher Education Full Report from the Engaged Futures Consultation, December 2014.

Mills N et al. 2014. Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences. Trials 15, 323 (2014). https://doi.org/10.1186/1745-6215-15-323.

Wilson, C. 2011. ‘The Social Transformation of the Medical Profession in Urban Kerala: Doctors, Social Mobility and the Middle Classes,’ in Being Middle-Class in India: A way of life. Henrike Donner (Ed.) London: Routledge, pp139-161.

Wilson, C. 2010. ‘Thinking through CT Scanners: the value(s) of imaging technologies in Kerala’, in Development, Democracy and the State, Critiquing the Kerala Model of Development, Ravi Raman (Ed.), London: Routledge, pp 118-134.

Wilson, C. 2010. ‘Eating, eating is always there’: food, consumerism and cardiovascular disease. Some evidence from Kerala, south India. Anthropology & Medicine, 17(3), 261–275. https://doi.org/10.1080/13648470.2010.526699.

Wilson, C. 2008. ‘The ‘Craze’ for Medicine and Engineering: Aspirations and Inequalities in Kerala, South India’, Amsterdam School for Social Science Research, Working Paper No. 03/08.

Wilson, C (2003) Understanding the dyanamics of socio-economic mobility: Tales from two Indian villages. Overseas Development Institute Working Paper.

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