Clinical Trials Unit Research Articles

Challenges and prospects of clinical trials in Nigeria - Lessons from the WHO COVID-19 solidarity plus trial

Conducting randomized clinical trials (RCTs) during a pandemic is essential for obtaining timely evidence on safe and effective treatments, but it presents numerous obstacles. During the COVID-19 pandemic, the World Health Organization (WHO) sponsored multinational RCTs investigating repurposed drugs among hospitalized COVID-19 patients across countries with varying clinical research capacities. In Nigeria, several challenges hindered our progress, including inadequate infrastructure, initial insufficient investigator certification and expertise, and delays in securing regulatory approvals due to bureaucratic hurdles. Despite these challenges, the WHO-sponsored Solidarity Plus Trial (SPT) offered valuable opportunities to enhance research capacity, streamline participant enrolment through electronic randomization, and bolster infection prevention and control measures for healthcare workers. Moreover, the trial enabled us to upgrade infrastructure at multiple sites, facilitating improved case detection through more testing and data collection. A crucial lesson learned was the importance of expediting trial initiation to capitalize on the limited window for data collection during an outbreak. To optimize RCTs during pandemics, we advocate for enhanced community engagement, collaborative efforts across sectors, strengthened research capacity, flexible regulatory frameworks, and the establishment of adaptive clinical trial units. By addressing these challenges and leveraging opportunities, we can significantly enhance the efficiency and impact of RCTs during public health emergencies.

A new trial monitoring plan (TMP) template for clinical trials: output from a Delphi process

BackgroundMonitoring is a crucial part of trial conduct and ensures that participants’ data is fairly represented, and future healthcare information is enhanced. This project aims to improve trial monitoring by creating a trial monitoring plan (TMP) template with input from individuals experienced in monitoring clinical trials.MethodsA review of monitoring plans received from UK Clinical Research Collaboration (UKCRC) registered clinical trials units (CTU)s created the basis for a preliminary TMP template and a Delphi survey. The TMP template was finalised after 2 rounds of a Delphi survey and a two-part consensus meeting including trialists with experience and expertise in monitoring clinical trials.ResultsWe received 31 monitoring plans from UKCRC-registered CTUs and reviewed over 800 monitoring items for inclusion in a TMP template, selecting items based on guidelines such as Good Clinical Practice (GCP) and our monitoring experiences. For certain items, further expert input was required. A total of 66 items were chosen for a Delphi survey involving 47 participants from 25 UK CTUs and industry. After the first round, all 66 items were retained, and six additional items were suggested by Delphi participants. In the second round, 37 items reached consensus for inclusion in the TMP template. The Delphi process was followed by a consensus meeting with 9 participants from 9 UK CTUs and industry. Participants in the consensus meeting voted on the 32 further items that had not reached the definition of consensus within the Delphi, regarding each item’s inclusion in or exclusion from the TMP template. The voting resulted in 18 items being excluded, leaving 14 items to be included in the TMP template. The process overall resulted in a standardised TMP template with input from many individuals with interest, experience, or expertise in monitoring clinical trials.ConclusionA TMP template was developed building on the currently used monitoring plans and with input from those experienced in clinical trial monitoring. Using a centrally developed good quality TMP template should contribute towards maintaining consistency in monitoring standards across all CTUs, resulting in higher research quality and improved quality assurance. Its use should provide reassurance to participants that their participation is carefully monitored to ensure that their data or any samples provided are treated with confidentiality, integrity, and respect and that their rights and well-being are protected.

A Pilot Study on the Collection of Adverse Event Data from the Patient Using an Electronic Platform in a Cancer Clinical Trial Unit.

Accurate and robust adverse event (AE) data collection is crucial in cancer clinical trials to ensure participant safety. Frameworks have been developed to facilitate the collection of AE data and now the traditional workflows are facing renewal to include patient-reported data, improving completeness of AE data. We explored one of these workflows in a cancer clinical trial unit. The study was a single-site study conducted at a tertiary hospital located in Australia. Patients consenting to a clinical trial were eligible for inclusion in this study. Participants used an electronic platform-My Health My Way (MHMW)-to report their symptomatic data weekly for 24 weeks. A symptom list was included within the platform, along with a free text field. Data reported via the platform was compared with data recorded in the patient's medical chart. Time taken to compile data from each source was recorded, along with missing data points. Agreement between patient-reported data and data recorded in the medical notes was assessed using Kappa and Gwet's AC1; time taken to compile data and missing data points were assessed using a Wilcoxon signed rank test. Low agreement was found between patient- and clinician-reported data (-0.482 and -0.159 by Kappa and Gwet's AC1 respectively). Only 127 (30%) of the total 428 AEs were reported by both MHMW and medical notes. Patients reported higher rates of symptoms from the symptom list, while clinicians reported higher rates of symptoms outside of the symptom list. Time taken to compile the data from MHMW was significantly less than that taken to review medical notes (2.19min versus 5.73min respectively; P < 0.001). There were significantly less missing data points from the MHMW data compared with the medical notes (1.4 versus 7.8; P<0.001). This study confirms previous reports that patient- and clinician-reported adverse event data show low agreement. This study also shows that clinical trial sites could significantly reduce the work performed by research staff in the collection of adverse event data by implementing an electronic, patient-reported platform.

What is the carbon footprint of academic clinical trials? A study of hotspots in 10 trials

BackgroundClinical trials are fundamental to healthcare, however, they also contribute to anthropogenic climate change. Following previous work to develop and test a method and guidance to calculate the carbon footprint...

Faricimab versus bevacizumab for neovascular age-related macular degeneration: Cost analysis based on real-world data from the Swedish Macula Registry.

To analyse the impact on cost if faricimab is used as the first-line treatment for neovascular age-related macular degeneration (nAMD) compared to standard treatment with bevacizumab. Retrospective registry study including real-world data from the Swedish Macula Registry between 2017 and 2022. The observed number of injections and visits for bevacizumab during the first two years of treatment was used (n = 437 patients). Number of faricimab injections was obtained from published clinical trial data and unit costs mostly from publicly available Swedish sources. The provider cost included medication and visit cost and societal cost included additionally patient travel cost. Costs are presented in 2023 EUR. The incremental societal cost of faricimab was 277 EUR per patient compared to bevacizumab in the base case. Medication cost was higher (1516 EUR) while visit cost (-1183 EUR) and patient travel cost (-56 EUR) were lower due to longer injection intervals. Faricimab was of similar cost as bevacizumab for patients residing far from the clinic. The faricimab injection interval and the number of bevacizumab injections were major drivers of uncertainty in the results. Faricimab represents a cost-effective alternative to bevacizumab for patients with nAMD in Sweden. Its extended treatment interval is particularly beneficial for patients living far from clinics, and if the real-life faricimab injection interval extends beyond 12 weeks. Our findings emphasize faricimab's potential to free up healthcare staff to treat a larger patient population with existing clinic resources.

Health visiting research: Overcoming barriers

Research is often perceived as something that is carried out by scientists in labs or by academics in clinical trial units, and not something that many health visitors in practice can relate to. The recent national drive to move the nursing research agenda forward may seem daunting to many health visitors, resulting in them disengaging. This article highlights why it is important for health visitors to engage with research and how research aligns with health visiting practice. It explores the common barriers to engagement at every level using the socio–ecological model and discusses the ways in which health visitors can contribute to the national agenda. It is hoped that demystifying some of the research roles will make research more accessible to health visitors in their daily practice.

Establishing Protocols for Glycaemic Index Clinical Trials in an Academic Setting in Sri Lanka

The University of Peradeniya in Sri Lanka has initiated a Healthy Human Clinical Trial Unit (CTU) dedicated to post-prandial glycaemic response (PPGR) analysis. The present study, involving 42 participants aged 22-25 years, assessed the glycaemic index (GI) of four rice varieties: Super Kernel, Rathu Suduru, Ceylon Purple, and Red Fragrant. The results identified GI values ranging from 40 to 61, categorizing these varieties into low and medium GI groups, with Super Kernel and Rathu Suduru representing the lowest (40 ± 5.5) and the highest (61 ± 5.5) GI values, respectively. Glycaemic load (GL) values ranged from 8 to 12, falling into low and medium categories. This pioneering initiative validates the effectiveness of CTU in precise GI and GL evaluation for food labelling, which are essential for informing consumers about how different types of food impact the sugar levels in the bloodstream. Also, it is a precedent for future clinical nutrition research, emphasizing the need for consistent and harmonized methodologies in academic and regulatory contexts to support broader public health goals by providing accurate nutritional information to consumers. The processes and standards are detailed in a comprehensive guidebook (ISBN 978-624-94637-0-7), supporting the continuation and expansion of further PPGR studies.

Clinical Trial IBD Unit: The Role of the Study Nurse in Conduction of Trials and Patients' Care.

Clinical Trial IBD Unit: The Role of the Study Nurse in Conduction of Trials and Patients' Care.

PRECIOUS study (PREterm Caesarean/vaginal birth and IVH/OUtcomeS): does mode of birth reduce the risk of death or brain injury in very preterm babies? A cohort and emulated target trial protocol

IntroductionVery preterm babies are at risk of poor neurodevelopmental outcomes and death. Intraventricular haemorrhage (IVH) after birth is the most prevalent cause of this. Birth by caesarean section may protect...

Evaluating the use of paracetamol to prevent fasting headache during the first week of Ramadan: A randomized, open-label, clinical trial.

Fasting headaches frequently occur during the first few days of Ramadan, and treatment is challenging because of fasting. This study aimed to evaluate the effect of extended-release paracetamol on preventing fasting headaches. A randomized, open-label clinical trial investigated the efficacy of extended-release paracetamol at a daily dose of 1330 mg in preventing fasting headache. Adults aged 18 years and older were recruited through the Clinical Trial Unit at the King Saud University Medical City. The eligible participants in the study fasted 13.5 h daily during the first week of Ramadan. Participants in the treatment and control arms were followed up to investigate the occurrence, severity, and timing of headache symptoms via self-reporting using a standardized headache diary scale with a daily online link or phone call. The primary outcome was the frequency of headache episodes while fasting during the first week of Ramadan. A total of 238 participants were enrolled and randomized. Of these, 173 followed the protocol (80 treated, 93 control) for at least the first day and were included in the analysis. Most participants were young and healthy, with a mean age of 32.2 ± 10.2 years. More men were included in the study (102/173; 59.0%), a small proportion of participants were smokers (31/173; 17.9%), and almost all participants reported being coffee drinkers (165/173; 95.4%); nonetheless, these characteristics were evenly distributed between the two groups in the study. The overall incidence of headache episodes was 33.0% (57/173) on day 1 and decreased to 11.3% (18/159) on day 7. On average over the 7 days, no significant effect was observed for the treatment on the incidence of headache, as the findings from the generalized estimating equation model indicated (β = -0.398, p = 0.084; odds ratio = 0.67, 95% confidence interval [CI] 0.42-1.06). Moreover, there was initially no significant difference in the incidence of headache episodes between the treatment and control groups. However, the treatment group had significantly fewer headache episodes during fasting than the control group on day 3 (4/72 [5.6%] vs. 15/91 [16.5%], p = 0.031; relative risk [RR] = 0.34, 95% CI 0.12-0.97) and day 6 (5/69 [7.2%] vs. 20/90 [22.2%], p = 0.010; RR = 0.33, 95% CI 0.13-0.82). No adverse effects were observed during the study period. No significant differences were observed in the occurrence of fasting headaches between the two groups on most days during the study period. Additional studies are required to address fasting headaches during the first week of Ramadan.

1559P Equity of access and clinical impact of genomic testing in patients with cancer in a UK early phase clinical trials unit

1559P Equity of access and clinical impact of genomic testing in patients with cancer in a UK early phase clinical trials unit

Population pharmacokinetics of oral fosfomycin calcium in healthy women.

Fosfomycin is an antibiotic extensively used to treat uncomplicated urinary tract infections in women, and it is available in different salts and formulations. The European Medicines Agency (EMA) recommends further studies to characterize the pharmacokinetics of fosfomycin calcium for oral administration and to justify its dosage recommendation. A population pharmacokinetic model of fosfomycin calcium was developed after oral administration to healthy women. A clinical trial (a randomized, open-label, bioavailability study of single and multiple doses of 1000 mg capsules, single dose of 500 mg capsule and single dose of 250 mg/5 mL suspension of oral fosfomycin calcium under fasted conditions in healthy women volunteers, Code: PD7522.22, EudraCT: 2020-001664-28) was carried out at the Clinical Trial Unit, Araba University Hospital (Vitoria-Gasteiz, Spain). Twenty-four healthy women were included in the study, and plasma samples were collected at different times over a period of 24 h. The concentration-time data of fosfomycin in plasma were modelled by a population approach using a nonlinear mixed-effects modelling implemented by NONMEM 7.4 (ICON Clinical Research LLC, North Wales, PA, USA). The pharmacokinetics of fosfomycin was best described by a two-compartment model. Creatinine clearance and body weight were identified as covariates for fosfomycin clearance and volume of distribution, respectively. This study provides relevant information on the pharmacokinetic profile of fosfomycin in women after oral administration as calcium salt. This population model may be very useful for establishing dosage recommendations of fosfomycin calcium to treat urinary tract infections in women.

FOUND Trial: randomised controlled trial study protocol for case finding of obstructive sleep apnoea in primary care using a novel device

IntroductionObstructive sleep apnoea (OSA) is a common, but underdiagnosed, sleep disorder. If untreated, it leads to poor health outcomes, including Alzheimer’s disease, cancer, cardiovascular disease and all-cause mortality. Our aim...

Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project

BackgroundIt is essential that electronic data collection (EDC) systems are both compliant with regulations and the principles of Good Clinical Practice (GCP) to allow for the timely and accurate reporting of data including safety data. For clinical trials of investigational medicinal products (CTIMPs), investigators must immediately report to the sponsor any serious adverse event (SAE) that occurs in a site for which they are responsible. It is therefore expected that sponsors provide systems for timely review and reporting should a SAE be classified as a suspected unexpected serious adverse reaction (SUSAR). Challenges arise when data related to adverse events (AEs) needs to be re-entered for SAEs; this can be prone to error and may delay reporting. Additionally, recognising what has changed from an initial SAE report when an investigator responds to queries raised can cause errors.MethodA multi-disciplinary working group came together from a UK academic clinical trials unit (CTU) to establish if an electronic system could be created in the unit’s open-source EDC system—REDCap, to manage SAEs in an efficient way.ResultsA module has been created in REDCap to facilitate electronic SAE reporting: enabling an AE form to automatically trigger an SAE form for any AE which is also a SAE, prepopulating relevant fields of the SAE form, reducing the risk of delay and error when entering data into the SAE form. The system has also been developed with an embedded code to allow for instant visual recognition of any data updated following reporting to allow the sponsor to immediately review and resolve SAEs in a timely manner, complying with UK regulatory reporting. This functionality ‘The eSAE Project’ is now an active project for all of our new trials where data collection is undertaken using the REDCap system.ConclusionThe eSAE Project coded into REDCap offers a unique way of populating SAE forms with information already entered in the initial AE forms as applicable, coupled with highlighting any updates during the lifetime of the SAE for sponsors to identify any new information that needs to be reassessed to process and report the SAE.

Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and their corresponding protocols

BackgroundRetaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol.MethodsNinety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate.ResultsPlans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use “combined strategies” to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies).ConclusionRetention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.

QAPI 113 - A Comprehensive infection control response to a norovirus outbreak on an adult inpatient hematologic oncology and clinical trials unit

QAPI 113 - A Comprehensive infection control response to a norovirus outbreak on an adult inpatient hematologic oncology and clinical trials unit

Global perspective of barriers in research among oncologists from low-middle income countries.

e13781 Background: Cancer research in low-middle income countries (LMICs) face unique challenges, hindering advancements in patient care. Understanding the practices, barriers and strategic needs encountered by oncologists in LMICs is essential for enhancing research capacities and patient outcomes. This study aimed to assess the barriers and facilitators of research among oncologists in LMICs. Methods: This online cross-sectional survey engaged a diverse group of practicing oncologists from LMICs between December 8, 2023 and February 6, 2024. Respondents include both oncology trainees and consultants primarily from Asia (63%), Africa (18%) and Europe (10%). Using a validated questionnaire (test-retest reliability: 0.98), data analysis was performed using frequency and percentages to detail the survey responses, with 95% confidence intervals calculated to ensure the findings reliability. Results: A total of 276 participants from 29 countries, with a mean age of 38 years, responded to the survey. Fifty three percent (n=146) were male and 46% (n = 126) were female, four participants chose not to disclose. Majority of the respondents were trained in medical oncology and related specialties, 71% (n = 196). Forty one percent (n = 113) of them had less than 5 years’ experience as a cancer physician, while a significant proportion were mid-career oncologists with 5 to 15 years of experience. Regarding individual level barriers; 3% (n = 7) had 60 - 100% protected research time, 3% (n = 8) had local and international mentors, 36% (n = 100) had no biostatistical training, 50% (n = 138) had no clinical trial design training, 11% (n = 29) had utilized qualitative design, 60% (n = 165) had not participated in a population-based study, and 83% (n = 228) had not participated in translational research. In relation to system-level barriers; 30% (n = 84) had inadequate research infrastructure and 43% (n = 120) had no clinical trials unit. Respondents rated the degree of implementation of new research findings into local clinical practice as 3 on a five-point Likert scale. Conclusions: This study highlights the critical gaps in research capacity, resource availability, and infrastructure among oncologists from LMICs. Addressing these barriers through targeted interventions is imperative for advancing cancer research and improving patient outcomes in LMIC settings.

A single-centre study evaluating a geriatric screening tool in oncology phase I trial patients.

Though cancer is more prevalent in the older population, this patient group are underrepresented in phase I oncology trials. We evaluated the use of a geriatric screening tool (SAOP3) in patients of 70 years of age or older who attended a Phase I Clinical Trials Unit, with the aim of assessing the feasibility of the tool and identifying potential unmet needs in this patient group. Twenty-two patients over the age of 70 completed the SAOP3 questionnaire. Geriatric impairments and needs were analysed with descriptive statistics. Qualitative responses were grouped in themes using structured thematic analysis. All of patients triggered at least 1 geriatric domain, most commonly mobility. Six core themes were identified as being important to the patient including family, friends and positivity. On cognition assessment over 20% of patients triggered as requiring further cognitive assessment. The group had a relatively high screen fail risk. In conclusion, routine geriatric screening withSAOP3 was feasible and identified areas of patient need. Results highlight the prevalence of psychological distress and cognitive impairment. Geriatric screening offers an opportunity for prehabilitation prior to trial and support during trial participation to optimise safety and improve trial access.

Total toxicity burden as a practical tool to quantify the overall severity of multiple adverse events in clinical trials.

3156 Background: Phase I clinical trials (CT) report adverse events (AEs) using the Common Terminology Criteria for AEs (CTCAE) version 5.0. If multiple qualitatively AEs are recorded in a trial, this results into manifold AE counts. Total toxicity burden (TTB) is defined for each patient as the sum of the highest grade of each AE divided by the number of AEs recorded [Thall, 2003]. We computed the TTBs for five groups of drugs studied in phase I trials. Methods: Pts treated from 2016 to 2022 in the phase I CT unit at MD Anderson Cancer Center were included. Clinical baseline prognostic factors [ECOG, age, Carlson comorbidity index (CCI)] were included and analyzed. AEs according to the CTCAE v5.0 were collected and simplified into 21 categories per trial and patient. Treatments were divided into: Cytotoxic agents (Chemo), Targeted Therapy (TT), Immune checkpoint inhibitors (ICI), Chimeric antigen receptor T cells (CART), or Cytokines (CYT). Using regimen-related AEs for evaluable patients, mean (SD) TTB for each treatment group was computed using each patent’s worst grade as the severity weight for each type of AE. Results: A total of 1322 evaluable pts from an initial sample of 2,350 were collected. Median age was 61 years (range, 19-92), 75.6% ECOG PS 1, median CCI was 8, and all pts were treated in a phase I/II CT. A total of 1782 AEs were treatment related and 3071 AEs were not treatment related. 715 evaluable pts (54.1%) had at least one treatment-related AE, and 902 patients (68.2%) had at least one treatment unrelated AE. A total of 265 (20.0%) grade 1 (G1) treatment-related AEs, 231 (17.5%) G2, 184 (13.9%) % G3, and 29 (2.2%) G4, and one G5 was reported. The most frequent G≥3 AEs overall were Neutropenia (N=54), Anemia (N=52), and low platelets (N=35). The most frequent G≥3 AEs per treatment group were Neutropenia (10%), Anemia (15%), and increased AST/ALT (13%) in group Chemo, Neutropenia (8%), Low platelets (9%), and Anemia (9%) in group TT, Increased AST/ALT (10%), Anemia (5%), and Pain (5%) in group ICI, Neutropenia (10%), Anemia (10%), and Low platelets (5%) in group CART, and Nausea/Vomit (3%), Pneumonitis (1%), and Infection (1%) in group CYT. Mean TTBs for the five treatment groups were 2.7 (SD=3.3) for Chemo, 2.9 (SD=3.6) for TT, 1.7 (SD=1.9) for IO, 5.9 (SD=5.1) for CART, and 0.8 (SD=1.8) for CYT. Corresponding G≥3 treatment-related AE rates were 21.7%, 21.0%, 12.2%, 52.4%, and 6.4% in the five treatment groups. It appears that CART is the most toxic treatment group based on TTBs and conventional analysis based on G&gt;3. These results suggest that propensity score-based comparisons of mean TTB to correct for selection bias using prognostic variables are warranted. Conclusions: TTB is a useful tool to quantify the mean severity of qualitatively different types of adverse events experienced by patients in a clinical trial, and mean TTB may be compared between treatment groups.

Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts

Background/aimsThe value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University’s Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration.MethodsWe held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper.ResultsActions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies.ConclusionsGiven that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit’s experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations.