UK Clinical Trials Offer Insights into Hypertension Treatment Strategies

Ethnographic Study Reveals Complexities of Trust and Practice in Medical Research

A comprehensive 17-month ethnographic study, focusing on building trust in clinical trials, has shed light on the intricate realities of medical research within a diverse London community. The research, part of a larger PhD, utilized an immersive approach to understand trial operations and participant experiences.

Diverse London Setting for Landmark Study

The study was conducted at a UK clinical trial center situated in a vibrant, multicultural area of London, reflecting the UK’s 2021 census data which reported the locale as 61.3% white, 14.1% Asian, and 10.5% Black. The personnel and participants mirrored this demographic richness, representing various nationalities and ethnicities. This center was selected for its proven track record and success in managing clinical trials, notably leading recruitment for a significant, long-term international hypertension study. This success has been linked to a substantial decline in local cardiovascular event rates, with improvements reportedly exceeding the national average by approximately 300%. The center’s research portfolio includes numerous areas of cardiovascular disease and diabetes.

Investigating Novel Hypertension Interventions

Three distinct trials investigating hypertension management were the focus of the observational study. These trials explored diverse therapeutic avenues: combinations of existing licensed drugs, the consumption of an organic substance in liquid form, and the implantation of a device into a major artery. The trials represented a mix of commercial and non-commercial funding, chosen to provide a broad understanding of trial practices within the same facility. One of the trials, “Snowdon,” aimed to personalize hypertension treatment by examining how “self-defined” ethnicity might influence responses to antihypertensive medications. Participants in this trial were prescribed combinations of established hypertension drugs. The study, jointly funded by a government body and a charitable organization, planned to recruit a high number of participants across more than ten UK sites.

‘Ben Nevis’ Trial Explores Device Implantation

“Ben Nevis” was a commercially sponsored study by a private biotechnology firm, focusing on implanting a device into a major artery via a delivery catheter. Its primary objective was to assess the safety and effectiveness of this device in reducing blood pressure for individuals with refractory hypertension. The global trial aimed to recruit up to 200 participants at 50 international locations, with the London center targeting single-figure recruitment. This trial employed a sham-controlled design.

‘Scafell Pike’ Examines Natural Substance Efficacy

The “Scafell Pike” trial investigated whether a natural, organic substance, administered in juice form, could mitigate the thickening of heart muscle (left ventricular hypertrophy) and arterial stiffness in hypertensive patients. This trial aimed for triple-digit participant recruitment at the London center. It was sponsored by a UK university and a UK hospital charity, utilizing a double-blind, randomized, placebo-controlled methodology.

All participants in these trials received travel expense reimbursement. Additionally, “Ben Nevis” and “Scafell Pike” offered participants a nominal fee of £150 for their time. A common motivation cited by participants across all trials was the prospect of optimizing or reducing their existing medication regimen.

Immersive Data Collection Techniques

Data collection spanned the entire participant journey, including pre-screening, routine consultations, and post-trial follow-ups, alongside observations of the center’s reception area. Lead researcher, DJR, conducted all observations, adopting a minimally disruptive approach. For the “Snowdon” trial, observations were opportunistic, occurring on scheduled participant days. For “Ben Nevis” and “Scafell Pike,” visits were coordinated with Principal Investigators (PIs) based on appointment schedules. Staff provided consent for observation at the study’s inception. Participants were asked for consent upon arrival, with DJR introducing himself and the study before commencing note-taking in the corner of the room. His unobtrusive presence led one clinical trial practitioner to describe him as “a piece of the furniture,” indicating successful immersion.

Ethnographic interviews, characterized by their informal and spontaneous nature during observations, were also utilized to gain deeper insights into participants’ perspectives. These often occurred when staff briefly left the room. Staff interviews were typically conducted after participant visits had concluded. Interviews with healthcare professionals and some participants were conducted. However, due to the COVID-19 pandemic, interviews with some staff, including a PI on the “Snowdon” trial and both staff members on “Ben Nevis,” were not feasible. The PI for “Scafell Pike” was interviewed pre-pandemic. Participant interviews were limited post-lockdown due to concerns about their “vulnerable” status, though researchers felt sufficient data was collected to reach “information power,” indicating data saturation and meaningful insights.

Rigorous Thematic Analysis Underpins Findings

The analysis of 136 pages of fieldnotes and 86 pages of interview transcripts was conducted using NVIVO 12, employing thematic analysis. This qualitative method allowed for in-depth exploration of identified themes. Initial familiarization with the data, achieved through typing fieldnotes and transcribing interviews, facilitated the spotting of patterns. Thematic analysis involved iterative coding, with codes refined through discussions between DJR and co-authors, critically examining assumptions from an outsider’s disciplinary viewpoint. The writing process itself was integral to analysis, involving continuous data review and connection-making.