Case Studies


Phase III study requiring full service support including regulatory affairs and ethics

A multinational large scale cardiovascular primary prevention trial; the study was long term (5 year) and event driven (until a cardiovascular event occurs) or the study is terminated. CCA oversaw sites in the UK and Ireland.

Agent

An analgesic, antipyretic, anti-inflammatory and antiplatelet salicylate drug


The Challenge

The study reached out for a previously overlooked pool of patients since the current primary prevention database was lacking a moderate CVD risk population to benefit assessment of the drug safety and efficacy.

Moreover populations with lower risk (i.e. Primary prevention)  require far larger number of patients than secondary or high risk population trials. Key reason to restrict the population to the moderate cardiovascular risk category (15% 5 year) was the positive risk to benefit ratio.
The sponsor  was looking for high recruiting sites across Europe and the US in order to reach their recruitment targets within the given timelines.
Patient retention and follow up on the study for five years was crucial to the study’s success.

The CCA approach – Since high recruitment levels were crucial to the success of the study, CCA carefully approached Investigator’s recruitment, choosing only the best, most experienced GPs and Primary Care institutions with a large enough patient population in order to  make sure that each individual site meets recruitment targets. Moreover highly experienced monitoring staff was assigned to monitor and oversee recruitment and data collection at each of the sites. 

What is more, qualified research nurse staff was assigned to assist the site according to the site’s needs in searching through patient database in order to indicate potential patients, as well as in patient screening and randomisation.


The Outcome

We met the study targets; each site managed to recruit the required number of patients

 

 

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