The role and potential contribution of clinical research nurses to clinical trials

2007 ◽  
Vol 0 (0) ◽  
pp. 070621074500021-??? ◽  
Author(s):  
Karen Spilsbury ◽  
Emily Petherick ◽  
Nicky Cullum ◽  
Andrea Nelson ◽  
Jane Nixon ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Potential Contribution ◽  
Research Nurses

scholarly journals The conundrum of clinical trials and standard of care in sub-Saharan Africa – the research nurse perspective

2019 ◽  
Vol 24 (8) ◽  
pp. 649-660 ◽  
Author(s):  
Jane Frances Ndyetukira ◽  
Richard Kwizera ◽  
Florence Kugonza ◽  
Cynthia Ahimbisibwe ◽  
Carol Namujju ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
Research Nurse ◽  
Loss To Follow Up ◽  
Resource Limited ◽  
Research Nurses ◽  
Sub Saharan

Background Nurses form a very important part of the health workforce in sub-Saharan Africa. Research nurses are critical to the implementation of clinical trials. The duties and responsibilities of a research nurse are complex and continue to evolve as new practices and guidelines are formulated. Aims In this paper, we have highlighted the major contributions of research nurses in HIV clinical trials in sub-Saharan Africa from the unique perspective of Ugandan nurses. Methods The requirements and challenges of two multi-site, randomised cryptococcal meningitis clinical trials in Uganda were assessed from the perspective of research nurses conducting complex research in resource-limited settings. Results Over the course of 8 years, approximately 1739 participants were screened and 934 people were enrolled into the two trials. The nurses found that patient education and engagement were among the most important predictors of success in minimising loss to follow-up. Conclusions Research nurses played a key role in communicating clinical research goals to patients, obtaining informed consent, minimising loss to follow-up, and ensuring that research practices are translated and implemented into standard of care. However, there remains a need to integrate the same level of care provided in clinical research studies to non-study patients.

The role of clinical research nurses in minority recruitment to cancer clinical trials

2021 ◽  
pp. 106590
Author(s):  
Kristen A. Legor ◽  
Laura L. Hayman ◽  
Janice B. Foust ◽  
Meghan L. Blazey
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Cancer Clinical Trials ◽  
Minority Recruitment ◽  
Research Nurses

scholarly journals Exploring obstacles to critical care trials in the UK: A qualitative investigation

2016 ◽  
Vol 18 (1) ◽  
pp. 36-46 ◽  
Author(s):  
Natalie Pattison ◽  
Nishkantha Arulkumaran ◽  
Sally Humphreys ◽  
Tim Walsh
Keyword(s):  
Clinical Trials ◽  
Critical Care ◽  
Clinical Research ◽  
Structured Interview ◽  
Research Network ◽  
Research Networks ◽  
Research Teams ◽  
Qualitative Interview Study ◽  
Research Nurses ◽  
The Uk

Background Clinical trials in critical care are often resource-intense, with many unique challenges. Barriers to effective recruitment and implementation of study intervention have not been explored in a UK context. Aim To identify facilitating factors and barriers to enrolling patients into critical care clinical trials within the UK from clinician’s perspectives. Methods A qualitative interview study was undertaken on behalf of the National Institute of Health Research critical care specialty group, in which research active clinicians across different Clinical Research Networks were interviewed. A loosely structured interview schedule was used, based on themes generated from the literature associated with accessing critical care trials. Research teams (critical care doctors, research nurses, and trial coordinators) from hospitals from each Clinical Research Network were contacted to try to achieve representation across the UK. Results Interviews were carried out across nine UK Clinical Research Networks with a range of doctors and research nurses. All hospitals were teaching hospitals with varying research nurse numbers and allocated consultant research sessions. There were a range of six to nine ongoing clinical trials in critical care for each centre representative interviewed. Data were analysed using framework analysis, and six final themes were identified related to factors associated with: centre, unit, resources, study, clinician, and patient/family. The most commonly cited barrier to conducting clinical trials was related to resources, namely insufficient human and financial resources, leading to staff and study recruitment difficulties. Clinical uncertainty and equipoise regarding comparative merits of trials were challenging in terms of engaging critical care teams. A number of patient and family factors added complexities in terms of recruitment; however, refusal rates were generally reported as low. Conclusion Flexibility in funding and employment by research teams enables continuity of studies and staff. Innovative measures to incentivise research nurses and clinical teams can help recruit more patients into trials. Research teams are highly committed to providing cover to recruit critical care trials, and a significant effort to anticipate barriers is undertaken; these endeavours are summarised to provide guidance for other teams wishing to address any potential difficulties.

Removing barriers to clinical research in community hospitals—The Fox Chase Cancer Center Partners experience

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6614-6614 ◽  
Author(s):  
M. A. O'Grady ◽  
S. J. Cohen ◽  
P. A. Keeley ◽  
E. Sein ◽  
B. J. Miller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Median Number ◽  
Cancer Center ◽  
Community Hospitals ◽  
Research Programs ◽  
Regulatory Burden ◽  
Clinical Trial Accrual ◽  
Research Nurses

6614 Background: Although the majority of cancer patients are treated in community hospitals, resources to support community clinical trials are often limited. The Fox Chase Cancer Center Partners (FCCCP) initiative is a large academic and community based oncology program in the Delaware Valley. We hypothesized that a detailed clinical research assessment within the 18 main community cancer research programs of the FCCCP would result in improved clinical trial accrual. Methods: The FCCCP clinical team completed research assessments at 10 affiliated community hospitals during 2004–2006 to evaluate active trials, research nurses and data managers, and research barriers. Institutions were benchmarked for staffing, processes, outreach, and quality improvement. Results were presented to administration at each hospital and impact on research accrual recorded. Results: In 2004, 371 patients were treated on clinical trials at 18 FCCCP community research programs. The median number of data managers, research nurses, and open protocols per site was 0.7, 1.6 and 48 respectively. The most common perceived barriers to accrual by investigators and research staff were regulatory burden, time, and awareness. Recommendations included: improved tumor registry identification of clinical trial candidates, increased staffing, improved web-based outreach, and targeted research affiliations. With regulatory burden a significant research barrier, the following IRB streamlining processes were recommended: NCI Central IRB, for-profit IRBs, IRB reciprocity, and centralized health system IRBs. With implementation of recommendations, 10/18 IRBs have transferred to the NCI-Central IRB for phase III cooperative group studies. The median number of data managers and research nurses per site increased to 1.25 and 1.7 respectively. Although the median number of open trials per site remained at 48, accruals to clinical trials increased to 805, representing a 116% increase. Conclusions: Research assessments are feasible in a large academic-community hospital partnership program and result in best practice recommendations with increased clinical trial accrual. Larger scale implementation of research infrastructure in community oncology programs is warranted. No significant financial relationships to disclose.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

scholarly journals Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research

2021 ◽  
Author(s):  
Elizabeth Biswell R ◽  
Michael Clark ◽  
Michela Tinelli ◽  
Gillian Manthorpe ◽  
Joanne Neale ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Social Care ◽  
Research Nurse
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