NCT07663058

Brief Summary

This PhD explores the views of clinical research nurses (CRNs) and research-patients as they take part in clinical research within their respective roles, i.e., as a specialised staff member and as a patient volunteer. Clinical research is supported by NHS England as the best way to improve patient care by finding out whether a new treatment is better than what is available. CRNs are specialist nurses who manage and coordinate clinical research. CRNs are responsible for the safe running of research; they ensure the right information is collected for the research/trial to be successful. CRNs support the well-being of research-patients, by taking note of any new, or existing healthcare needs of research-patients while they take part in research. CRNs coordinate the activities that research requires, biological samples, scans, documentation. Balancing their responsibility towards research-patients, on the one hand, and research management, on the other, can bring unique challenges for the CRN. CRNs can feel conflicted between these two responsibilities, e.g., when they think that a drug trial, or the research activities in a study is at odds with the research-patient's best interest despite the research-patient's consent to take part in research. CRNs are tasked with maintaining/facilitating recruitment of research-patients, this can be a challenging aspect of their role especially if they feel pressured to approach patients to take part in research. Currently, we know little about how CRNs balance these two responsibilities, or what other problems CRNs have in their everyday role when balancing these responsibilities. Finding out more about these aspects of the CRN role is important because it may not only improve job experience but can also give a better understanding of what can be changed to improve how CRN perform their role which could ultimately improve research-patients' experience of taking part in research. To address this issue, this PhD will explore CRNs and research-patients' views about clinical research, the challenges CRNs face, how CRNs balance their responsibilities, and what role does the relationship between CRNs, and research-patients play overall in what they say about their experience of taking part in clinical research. The researcher will interview and shadow CRNs and research-patients at a central NHS Hospital. This is a LISS/ESRC funded PhD at King's College London and supported by Guy's and St Thomas NHS Foundation Trust.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
28mo left

Started Aug 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

June 17, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

Clinical Research NursesResearch-PatientsResearch ExperienceTherapeutic MisconceptionEthical ChallengesCRN Dual Role

Outcome Measures

Primary Outcomes (1)

  • Recruitment of CRNs and Research-Patients

    Recruitment of up to 15 CRNs and up to 15 research-patients for interviews

    End of recruitment date is 30 Dec 2028

Other Outcomes (1)

  • Addressing the Research Aims and Research Questions

    3 years

Study Arms (2)

Clinical Research Nurses (CRN Group)

CRNs working in adult clinical research

Other: InterviewsOther: Non-participant observations

Research-Patients

Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over)

Other: InterviewsOther: Non-participant observations

Interventions

Semi-structured interviews

Clinical Research Nurses (CRN Group)Research-Patients

Non-participant observations of clinical research visits

Clinical Research Nurses (CRN Group)Research-Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CRN, research-patients

You may qualify if:

  • Research-patients aged above 18 years old.
  • Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over) at GSTT.
  • Research-patients who are willing and able to provide informed consent.
  • CRN willing and able to give consent.

You may not qualify if:

  • Patients who showed an interest in taking part in research but were not recruited, e.g. due to screen failure, or ineligibility.
  • Research-patients recruited to research via proxy consent, e.g., next of kin.
  • Patients unable to provide informed consent, e.g., lacking mental capacity.
  • Research-patients considered vulnerable or at risk of harm, by the research team
  • Research-patients taking part in mental health or maternity trials or studies
  • Research-patients not fluent in English or not able to converse well in English
  • Clinical research midwives and clinical research nurses working in mental health, maternity, and paediatric research are excluded from this study.
  • CRNs not willing or unable to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

June 26, 2026

Record last verified: 2026-06

Locations