Article
Medicine, Research & Experimental
Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald, Isla S. Mackenzie
Summary: Background: This qualitative analysis explored stakeholder views on decentralised clinical trials (DCTs) to inform strategies for participant recruitment, retention, and adherence. Results: Factors such as trust, values, and burden influenced recruitment, retention, and adherence in DCTs. Increasing patient and public involvement can address many of these factors. Conclusion: DCTs require greater emphasis on communication and contact to build trust between participants and researchers despite a relative lack of in-person interaction.
Letter
Medicine, Research & Experimental
N. Goodson, P. Wicks, C. Farina
Summary: It is increasingly recognized that involving patients and the public in the design of clinical trials can lead to better recruitment, retention, and satisfaction. However, commercial organizations tend not to publish their findings, leading to a potential two-tier experience for trial participants depending on whether the trial they participate in will be industry-funded or government-funded.
Article
Pharmacology & Pharmacy
Amos J. de Jong, Tessa van Rijssel, Mira G. P. Zuidgeest, Ghislaine J. M. W. van Thiel, Scott Askin, Jaime Fons-Martinez, Tim De Smedt, Anthonius de Boer, Yared Santa-Ana-Tellez, Helga Gardarsdottir
Summary: Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in clinical trials, but also face regulatory challenges. Regulators recognize the opportunities of reducing participation burden and improving data representativeness in DCTs, while expressing concerns about investigator oversight and participant safety.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2022)
Article
Clinical Neurology
Olivia M. Bernstein, Joshua D. Grill, Daniel L. Gillen
Summary: Early study exit in Alzheimer's disease clinical trials can reduce statistical power and increase bias risk. The type of study partner may influence the completion rate of the trial.
ALZHEIMERS RESEARCH & THERAPY
(2021)
Article
Medicine, Research & Experimental
Lacey Andrews, Todd H. Davies
Summary: Clinical research sites often struggle with recruiting and retaining vulnerable populations. It is important to ensure that individuals in vulnerable populations have access to any relevant clinical research, while providing appropriate protections. Establishing trust is crucial for effective recruitment and retention of vulnerable populations, especially with the new trends in the drug development industry.
CONTEMPORARY CLINICAL TRIALS
(2022)
Article
Clinical Neurology
Jessica B. Langbaum, Julie Zissimopoulos, Rhoda Au, Niranjan Bose, Chris J. Edgar, Evan Ehrenberg, Howard Fillit, Carl Hill, Lynne Hughes, Michael Irizarry, Sarah Kremen, Darius Lakdawalla, Nancy Lynn, Kristina Malzbender, Tetsuyuki Maruyama, Holly A. Massett, Deep Patel, Desi Peneva, Eric M. Reiman, Klaus Romero, Carol Routledge, Michael W. Weiner, Stacie Weninger, Paul S. Aisen
Summary: Clinical trials for Alzheimer's disease face challenges in recruiting study participants, with slow enrollment, long completion time, and high costs. In 2020, an advisory panel of experts from various fields convened to assess the critical challenges in recruitment and develop recommendations to accelerate the development of novel therapies for AD.
ALZHEIMERS & DEMENTIA
(2023)
Article
Geriatrics & Gerontology
Thomas Buttgereit, Andriko Palmowski, Noah Forsat, Maarten Boers, Miles D. Witham, Nicolas Rodondi, Elisavet Moutzouri, Antonio Jesus Quesada Navidad, Arnoud W. J. van't Hof, Bart van der Worp, Laura Coll-Planas, Marieke Voshaar, Maarten de Wit, Jose da Silva, Sven Stegemann, Johannes W. Bijlsma, Marcus Koeller, Simon Mooijaart, Patricia M. Kearney, Frank Buttgereit
Summary: Older people are underrepresented in clinical trials, but identifying key barriers and discussing solutions based on experience from current European trials have shown ways to improve recruitment and retention. Barriers such as health conditions and cultural beliefs were addressed by increasing recruitment sites, providing extra time, and improving communication. Special recognition and targeted approaches are needed for recruiting and retaining older patients.
Article
Health Care Sciences & Services
DaSol Amy Hwang, Alex Lee, Jae Min Song, Hae-Ra Han
Summary: This study identified 9 categories of recruitment and retention strategies for web-based intervention trials targeting racial and ethnic minorities, including authentic care, accommodation of time, place, and transportation, financial incentives, diversity among the study team, multiple modes of communication, existing community relationships, prioritizing features of web-based intervention, combined recruitment methods, and self-directed web-based intervention with human support. Prioritizing features of web-based intervention or providing human support were particularly important for promoting recruitment and retention of racial and ethnic minorities in web-based intervention trials. Future research should further explore successful recruitment and retention methods among different racial and ethnic groups for web-based interventions.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2021)
Review
Medicine, General & Internal
Taylor Coffey, Eilidh M. Duncan, Heather Morgan, Louisa Lawrie, Katie Gillies
Summary: This systematic mapping review examines the application of behavioral approaches to recruitment and retention issues in clinical trials. The majority of the included studies focused on recruitment and participant behaviors, with some targeting underserved populations. However, most studies lacked specificity in defining the target behaviors, making replication difficult. It is recommended that future research improves methodological rigor and transparency to enhance recruitment and retention outcomes.
Article
Multidisciplinary Sciences
Rebecca A. Slotkowski, Shirley F. Delair, Kari A. Neemann
Summary: Research registries are effective in boosting recruitment for clinical trials. This study aimed to understand how parents make the decision to enroll their children in a pediatric participant research registry (PPRR). The results showed that parents have positive attitudes towards PPRRs, with a preference for recruitment by primary care providers or nurses in clinics rather than through social media.
Review
Pharmacology & Pharmacy
Amy Rogers, Giorgia De Paoli, Selvarani Subbarayan, Rachel Copland, Kate Harwood, Joanne Coyle, Lyn Mitchell, Thomas M. MacDonald, Isla S. Mackenzie
Summary: This study aims to evaluate the design and conduct of decentralised clinical trials using quantitative and qualitative approaches. The quantitative analysis included 45 randomised clinical trials, with the primary outcome being the number of randomised participants. The qualitative analysis included 117 documents discussing or evaluating decentralised clinical trials. The results showed heterogeneity in the design and reporting of trials, and insufficient evidence to support the effectiveness of DCT methods in trial recruitment. The qualitative analysis identified four themes: value, burden, safety and equity. Further research on participant and stakeholder experiences of DCTs is recommended to maximize potential benefits.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2022)
Article
Pediatrics
Ryan C. L. Brewster, Jecca R. Steinberg, Christopher J. Magnani, Jasmyne Jackson, Bonnie O. Wong, Nishma Valikodath, Justin MacDonald, Anna Li, Paula Marsland, Steven N. Goodman, Alan Schroeder, Brandon Turner
Summary: This study evaluates the reporting and representation of racial and ethnic minoritized populations in all US pediatric clinical trials on ClinicalTrials.gov. The results show that the representative enrollment of minoritized populations in children's clinical trials is still a challenge.
Article
Medicine, Research & Experimental
Arabella Scantlebury, Catriona McDaid, Stephen Brealey, Elizabeth Cook, Hemant Sharma, Arun Ranganathan, Joy Adamson
Summary: This study explored key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients, using a qualitative process evaluation of UK-wide orthopaedic surgical RCT and mixed methods randomised feasibility study. The findings highlighted the importance of factors such as equipoise, randomisation, communication, patient's circumstances, altruism, and trust in clinical and research teams in recruitment to surgical trials. It emphasized the need for a methodological shift to ensure that existing evidence on factors affecting recruitment to randomised controlled trials is used to optimize recruitment in future trials.
Article
Health Care Sciences & Services
Spurthy Dharanikota, Cynthia M. LeRouge, Victoria Lyon, Polina Durneva, Matthew Thompson
Summary: This study aims to identify the enablers of potential participants' trial engagement for clinical trials of smartphone-supported home tests. We conducted interviews to analyze dispositional and situational factors that influenced trial engagement. Situational enablers included clinical affiliation, personal advice, recruitment strategies, financial incentives, and insurance status, while dispositional enablers included digital health literacy, motivation for medical research, personal innovativeness, altruism, curiosity, positive attitude, and potential to minimize doctors' visits.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2021)
Review
Medicine, General & Internal
Deniz Kilicel, Franco De Crescenzo, Giuseppe Pontrelli, Marco Armando
Summary: There is a strong need for rigorous trials for children and adolescents in mental health, but the recruitment rate is poor. Effective recruitment strategies are crucial, and using multiple recruitment methods can enhance the recruitment rate.
JOURNAL OF CLINICAL MEDICINE
(2023)
Article
Pediatrics
Matthew J. Ridd, Miriam Santer, Stephanie J. MacNeill, Emily Sanderson, Sian Wells, Douglas Webb, Jonathan Banks, Eileen Sutton, Amanda Roberts, Lyn Liddiard, Zoe Wilkins, Julie Clayton, Kirsty Garfield, Tiffany J. Barrett, J. Athene Lane, Helen Baxter, Laura Howells, Jodi Taylor, Alastair D. Hay, Hywel C. Williams, Kim S. Thomas
Summary: This study compared the clinical effectiveness and safety of four main types of emollients (lotions, creams, gels, and ointments) commonly used for childhood eczema. The results showed no difference in eczema severity between the different types of emollients over a 16-week period. Users need to be able to choose an emollient that they are more likely to use effectively.
LANCET CHILD & ADOLESCENT HEALTH
(2022)
Article
Urology & Nephrology
Simon J. Crabb, Gareth Griffiths, Denise Dunkley, Nichola Downs, Mary Ellis, Mike Radford, Michelle Light, Josh Northey, Amy Whitehead, Sam Wilding, Alison J. Birtle, Vincent Khoo, Robert J. Jones
Summary: The addition of capivasertib to docetaxel may extend overall survival in patients with metastatic castration-resistant prostate cancer. Subgroup analysis suggests that the benefit is maintained in patients previously treated with androgen receptor-targeted agents.
Article
Medicine, Research & Experimental
L. Clark, B. Fitzgerald, S. Noble, S. MacNeill, S. Paramasivan, N. Cotterill, H. Hashim, S. Jha, P. Toozs-Hobson, T. Greenwell, N. Thiruchelvam, W. Agur, A. White, V. Garner, M. Cobos-Arrivabene, C. Clement, M. Cochrane, Y. Liu, A. L. Lewis, J. Taylor, J. A. Lane, M. J. Drake, C. Pope
Summary: This study aims to compare the effectiveness of surgical treatment and endoscopic bulking injections in women with recurrent or persistent SUI. The primary outcome is symptom severity measured using the ICIQ-UI-SF questionnaire, and secondary outcomes include longer-term clinical impact, symptom improvement, safety, operative assessments, sexual function, cost-effectiveness, and evaluation of patient and clinician perspectives. This research is important for guiding further treatment and improving symptoms and quality of life for women with this condition.
Article
Oncology
Elizabeth Smyth, Kelly Cozens, Daniel Griffiths, Kathryn L. Clark, Sean Ewings, Russell Petty, Tim Underwood, Rebecca C. Fitzgerald, James Tanner, Olivier Giger, Shubha Anand, Gareth Griffiths
Summary: This study aims to investigate the safety and biological effectiveness of administering Nivolumab after temozolomide treatment in patients with previously treated advanced oesophagogastric adenocarcinoma.
Article
Dermatology
Kate Greenwell, Katy Sivyer, Laura Howells, Mary Steele, Matthew J. Ridd, Amanda Roberts, Amina Ahmed, Sandra Lawton, Sinead M. Langan, Julie Hooper, Sylvia Wilczynska, Paul Leighton, Gareth Griffiths, Tracey Sach, Paul Little, Hywel C. Williams, Kim S. Thomas, Lucy Yardley, Miriam Santer, Ingrid Muller
Summary: This study aimed to explore the views and experiences of individuals who have used the Eczema Care Online interventions, in order to understand their effectiveness and identify influencing factors. The findings suggest that the interventions are easy to use and trustworthy, and can help individuals manage their eczema by improving their understanding and confidence in eczema management, reducing treatment concerns, and enhancing treatment adherence and management of irritants/triggers.
BRITISH JOURNAL OF DERMATOLOGY
(2023)
Article
Oncology
Gagan Prakash, Amandeep Arora, Marco Bandini, Giuseppe Basile, Mahendra Pal, Gareth Griffiths, Robert Cornes, Yao Zhu, Alejandro Rodriguez, Maarten Alberson, Andrea Necchi, Viraj Master, Curtis A. Pettaway, Philippe E. Spiess
Summary: Given the rarity of penile cancer, the Global Society of Rare Genitourinary Tumors (GSRGT) conducted a survey to identify the global variations in disease presentation and various aspects of its management. The results of this survey help identify research areas for multinational collaborative efforts which is a key mission of the GSRGT.
CLINICAL GENITOURINARY CANCER
(2023)
Article
Medicine, General & Internal
F. C. C. Hamdy, J. L. L. Donovan, J. A. Lane, C. Metcalfe, M. Davis, E. L. L. Turner, R. M. M. Martin, G. J. J. Young, E. I. I. Walsh, R. J. J. Bryant, P. Bollina, A. Doble, A. Doherty, D. Gillatt, V Gnanapragasam, O. Hughes, R. Kockelbergh, H. Kynaston, A. Paul, E. Paez, P. Powell, D. J. J. Rosario, E. Rowe, M. Mason, J. W. F. Catto, T. J. J. Peters, J. Oxley, N. J. J. Williams, J. Staffurth, D. E. E. Neal
Summary: A study in the UK showed that after 15 years of follow-up, the mortality rate of prostate cancer was low regardless of the treatment assigned. Therefore, the choice of therapy for localized prostate cancer involves considering the trade-offs between benefits and harms.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Article
Medicine, General & Internal
Miriam Santer, Megan Lawrence, Susanne Renz, Zina Eminton, Beth Stuart, Tracey H. Sach, Sarah Pyne, Matthew J. Ridd, Nick Francis, Irene Soulsby, Karen Thomas, Natalia Permyakova, Paul Little, Ingrid Muller, Jacqui Nuttall, Gareth Griffiths, Kim S. Thomas, Alison M. Layton
Summary: This study assessed the effectiveness of oral spironolactone for acne vulgaris in adult women. The results showed that spironolactone had significant improvement in acne symptoms and quality of life compared to placebo at 12 weeks and 24 weeks, with no serious adverse reactions reported. This suggests that spironolactone is a useful alternative to oral antibiotics for women with acne.
BMJ-BRITISH MEDICAL JOURNAL
(2023)
Article
Oncology
Simon Crabb, Robin Wickens, Sarah Jane-Bibby, Denise Dunkley, Megan Lawrence, Allen Knight, Robert Jones, Alison Birtle, Robert Huddart, Mark Linch, Jonathan Martin, Adam Coleman, Konstantinos Boukas, Hannah Markham, Gareth Griffiths
Summary: This study aims to evaluate the safety and efficacy of PD-L1 directed immunotherapy atezolizumab in UTSCC patients. Preliminary translational data suggests potential therapeutic value. Through this study, we hope to provide a new treatment option for UTSCC patients.
Article
Medicine, Research & Experimental
Simon Crabb, Alannah Morgan, Myra S. S. Hunter, Evgenia Stefanopoulou, Gareth Griffiths, Alison Richardson, Deborah Fenlon, Louisa Fleure, James Raftery, Cherish Boxall, Sam Wilding, Jacqueline Nuttall, Zina Eminton, Emma Tilt, Alice O'Neill, Roger Bacon, Jonathan Martin
Summary: This study aims to assess the effectiveness of a guided self-help cognitive behavioural therapy (CBT) intervention, delivered by the existing NHS prostate cancer CNS team, in reducing the impact of hot flushes and night sweats (HFNS) in men undergoing androgen deprivation therapy (ADT). It will evaluate the intervention through a randomized controlled trial and explore the key influencers to its implementation through a process evaluation.
Article
Pharmacology & Pharmacy
Merlin L. Willcox, Xiao-Yang Hu, Tom Oliver, Kerensa Thorne, Cherish Boxall, George He, Catherine Simpson, Becci Brotherwood, Alice O'Neil, Robert Waugh, Emma Tilt, Jeanne Trill, Neville Goward, Nick Francis, Michael Thomas, Paul Little, Tom Wilkinson, Jian-Ping Liu, Gareth Griffiths, Michael Moore
Summary: This study aimed to assess the feasibility of conducting a randomised placebo-controlled clinical trial of the Chinese herbal medicine Shufeng Jiedu (SFJD) for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in UK primary care. The results showed that the recruitment rate was lower than expected, possibly due to the lower incidence of AECOPD during the COVID-19 pandemic, patients starting antibiotics from rescue packs before seeing their GP, and challenges in the primary care workforce. However, the study was still able to demonstrate the feasibility of recruiting and randomising participants and identified approaches to address recruitment challenges.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Gastroenterology & Hepatology
John Reynolds, Shaun R. Preston, Brian O'Neill, Maeve A. Lowery, Lene Baeksgaard, Thomas Crosby, Moya Cunningham, Sinead Cuffe, Gareth Griffiths, Imelda Parker, Signe Lenora Risumlund, Rajarshi Roy, Stephen Falk, George B. Hanna, Frederick R. Bartlett, Alberto Alvarez-Iglesias, Michael P. Achiam, Magnus Nilsson, Guillaume Piessen, Narayanasamy Ravi, Dermot O'Toole, Ciaran Johnston, Raymond S. Mcdermott, Richard C. Turkington, Shajahan Wahed, Sharmila Sothi, Hugo Ford, Martin S. Wadley, Derek Power
Summary: The study compares trimodality therapy and perioperative chemotherapy for adenocarcinoma of the oesophagus and oesophagogastric junction, showing similar 3-year survival rates and outcomes in terms of surgery and quality of life.
LANCET GASTROENTEROLOGY & HEPATOLOGY
(2023)
Article
Respiratory System
Tom Wilkinson, Anthony De Soyza, Miles Carroll, James D. Chalmers, Michael G. Crooks, Gareth Griffiths, Manu Shankar-Hari, Ling-Pei Ho, Alex Horsley, Chris Kell, Beatriz Lara, Biswa Mishra, Rachel Moate, Clive Page, Hitesh Pandya, Jason Raw, Fred Reid, Dinesh Saralaya, Ian C. Scott, Salman Siddiqui, Andy Ustianowski, Natalie van Zuydam, Ashley Woodcock, Dave Singh
Summary: This study investigated the efficacy and safety of the anti-IL-33 monoclonal antibody tozorakimab in COVID-19 patients. The results suggest that tozorakimab could be a novel therapy for hospitalized COVID-19 patients.
Article
Medicine, General & Internal
Somnath Mukherjee, Christopher N. Hurt, Richard Adams, Andrew Bateman, Kevin M. Bradley, Sarah Bridges, Stephen Falk, Gareth Grif, Sarah Gwynne, Christopher M. Jones, PhilipJ. Markham, Tim Maughan, Lisette S. Nixon, Ganesh Radhakrishna, Rajarshi Roy, Simon Schoenbuchner, Hamid Sheikh, Emiliano Spezi, Maria Hawkins, Thomas D. L. Crosby
Summary: This study evaluated the role of F-18-Fluorodeoxyglucose positron emission tomography in assessing treatment response in patients with oesophageal cancer. The results showed that early metabolic response assessment after induction chemotherapy is not prognostic for treatment failure-free survival or overall survival, and should not be used to personalize systemic therapy selection.
Article
Medicine, General & Internal
Miriam Santer, Megan Lawrence, Susanne Renz, Zina Eminton, Beth Stuart, Tracey H. Sach, Sarah Pyne, Matthew J. Ridd, Nick Francis, Irene Soulsby, Karen Thomas, Natalia Permyakova, Paul Little, Ingrid Muller, Jacqui Nuttall, Gareth Griffiths, Kim S. Thomas, Alison M. Layton
Summary: Oral spironolactone is effective in improving symptoms and quality of life for adult women with acne vulgaris, with better efficacy compared to oral antibiotics.
BMJ-BRITISH MEDICAL JOURNAL
(2023)