JMIR Publications

ABSTRACT

Background:

Clinical trials are known to provide cause-effect results and data with low-levels of bias. However, the problem of lack of funding for clinical trials, which are considered expen-sive, means that academic sponsors are rarely able to conduct them. Academic trials are considered highly relevant for the valuable results they provide on clinical questions. This is why initiatives to conduct unfunded clinical trials have been identified as an im-portant issue to pay attention to in future studies. Therefore, we present our initiative through Roger's theory, which is highlighted in the literature for diffusing innovative change across organisations.

Objective:

The purpose of this paper was to describe our case of management for conducting a nonfunded nurse-led clinical trial based on our previous low-interventional clinical trial across a specific health organization and nurses.

Methods:

We conducted a low-intervention, non-externally funded, clinical trial using the human and material resources available on site. We managed our trial in a Clinical Trial Unit where there were staff, sources and ongoing commercial clinical trials. We conducted our trial based on an ongoing commercial trial and, to do so, we needed behavioural changes. We rely on Roger's theory, and we identify strengths and barriers to change by analysing actors' characteristics, perceptions of the situation, motivation and infor-mation. Afterwards, we divided the staff according to their characteristics on innova-tion and change into: permanent staff (research staff with a culture of change) and non-permanent staff (nursing staff with occasional attendance and resistance to change). First, we pre-selected to participate in our trial only those nurses who were more aware of change (innovators and pioneers) to avoid a massive rejection and later they joined (late adopters). We follow Roger's phases: for research staff, being aware of the fund-ing, we focus on the ‘persuasion phase’, while for nursing staff we mix the ‘knowledge and persuasion phase’, where we use pioneers and early adopters as a positive step for other nurses, and non-financial incentives (persuasion). Our trial consisted of different methods of vein cannulation, which procedure was performed in the ongoing commer-cial trial. Thus, the entire development of our low-interventional clinical trial was con-ducted without interfering at any point with the parallel commercial clinical.

Results:

The presented management was performed to effectively conduct our study, and we met our aims without external funding, without ethical impact during the commercial clinical trial. Costs remained low, primarily because the major expenses were covered by the commercial clinical trial as an inherent part of its design.

Conclusions:

Our initiative is cost-effective for conducting a low-interventionist clinical trial with no or limited funding. This initiative can be used by researchers with valuable academic research questions who do not have external funding to conduct it. Clinical Trial: ClinicalTrial.gov NCT04027218