In this series - The Pain Clinic - Kate O’Brien, formerly a senior research nurse and now a site consultant, examines the most common problems facing clinical trials today and what the potential solutions to them are (read the previous posts here). This week, the site feasibility process.
The feasibility process is necessary to determine which sites have the capacity, experience and suitable patients available in order to recruit effectively. However, the statistics demonstrate that this process is not reliable; less than half the sites selected deliver the numbers promised and one in ten fail to recruit a single patient. This results in costly delays to the trial completion. So – why is this area such a problem?
The site’s perspective
From the site’s perspective, there are a number of issues:
- The criteria provided by the Sponsor are often difficult to search on which leads to inaccurate results.
- There is no payment for completing feasibilities, so the coordinator must achieve a fine balance of time management, trying to provide enough information for the Sponsor, without impacting on the cost effectiveness of the unit.
- Sites are aware that the Sponsor is looking for a limited number of sites and so can over estimate their potential performance in order to secure work.
- Once a site has submitted a feasibility there is often a lengthy delay before they are notified that they have been awarded the trial, so in the meantime they may have applied for other similar studies.
- Sites that are not selected are often not notified, and so more time is spent contacting Sponsors. No useful feedback is provided on why they have not been successful, so the site is unable to act on this to improve. Often the only information they are offered is that the Sponsor has selected site’s that can provide more patients, which then leads to a vicious circle of site’s promising higher numbers in order to secure work and then not being able to deliver causing problems for the Sponsor. It is vital that the reasons for non-selection are reported to the site so that the Sponsor can then assess whether the site has taken steps to remedy the problem if approached in the future.
Searchable national database
From the Sponsor’s perspective the Protocol is unlikely to be finalised at the time of site selection, so they are unable to provide the final criteria. They are unaware of the computer systems used at site’s so cannot specify searchable information.
There are a limited number of computer systems used to collect patient data at sites. In Primary Care the GP systems of choice is a contractual framework to supply IT systems and services to GP practices and associated organisations in England. The two systems they provide are SystmOne and EMIS web. Both these systems have the facility for a single search to be built and exported to all users.
The Sponsor could assume the responsibility for constructing the search and exporting it to potential sites. The sites are then able to run the search and report the anonymised data collected. This would give the Sponsor control over the criteria used to identify possible numbers and provides a level playing field for sites as it standardises the information generated. Some sites may protest that they do not read code all their patient information, unless the circumstance occurs when this affects the majority of sites, perhaps the Sponsor needs to question the suitability of using these centres.
This solution would counteract the issues of sites not being provided with enough information at this stage, and not being able to search on some of the criteria provided.
Many of the more forward-thinking sites now have websites containing information about their team and studies that are recruiting. These can be used to check transparency over capacity and workload.
A national database of previous performance could provide valuable information. This could include
- Recruitment target
- Numbers enrolled
- Numbers randomised
- Number of screen failures
- Number of subjects discontinued
This information could then be used to extend the database to highlight sites that repeatedly meet or miss recruitment targets. Information on FPFV dates met and recruitment timelines would give a positive indication on a team’s efficiency to Sponsors just as the capacity to record Sponsor/MHRA inspection findings or concerns over a site’s performance may help to guide support to where it is needed. This record would help sites to provide supporting evidence for their feasibility assessment.
Transparency is necessary to maintain high standards within the industry and deliver the best experience not only for Sponsors but also for patients.