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Case History 1 - Trial Naive

Indication: Rheumatoid Arthritis
Country: United Kingdom
Sites: 34 sites in total / 14 used Site Nurse Support

Situation:

MRN was involved in selecting and setting up 34 sites within the UK for a late phase rheumatoid arthritis study, the remit being to identify and utilize a wide spread site base, covering all geographical regions and reaching into trial naive sites, where required. In order to do this, sites with little or no trial experience were considered, as well as sites with little or no research resource (i.e. sites that would not normally be chosen). Total study duration was 6 months per patient and involved 2-hour infusions once per month on site. With other assessments and QOL measures involved, each patient visit was in the region of 4 hours and had to be conducted within dedicated infusion suites where the patients could be treated comfortably. In total, 14 sites utilized MRN Site Nurse Support and 20 worked with their own resource.

Results:

• Over a 6 month period the MRN resourced sites recruited a total of 46 patients and those without MRN resourced recruited a total of 62.
• The MRN sites recruited on average 3.7 patients per site and the non-MRN sites an average of 3.1 per site.
• Provided inexperienced sites with resources to become involved with clinical trials

Patient recruitment: Trial naïve sites with MRN Site Nurse Support versus Experienced sites without MRN Site Nurse Support

The graph shows that the non-MRN sites performed better initially - which would be expected of sites utilizing internal staff who already know their patient population – however, as recruitment progresses MRN supported sites perform better due to the ongoing targeted search for patients. The figures are especially powerful considering that these sites are unlikely to have been considered if the resource hadn’t been provided.

 

For more case histories, click here.

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