Case Studies By Business Challenge

Proving Feasibility of Phase IV Study Protocol

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Situation

The mainstay of treatment for acute myocardial infarction (AMI) has traditionally been the rapid administration of a thrombolytic agent. The market for these agents is mature, with a number of players competing for market share. However, the increasing use of immediate percutaneous coronary intervention (PCI) is now eroding the thrombolytic/AMI market.

Our client’s agent, an established thrombolytic, is particularly suited for use in the pre-hospital environment. It can be administered by ambulance personnel thereby ensuring AMI patients receive thrombolysis at the earliest possible juncture. However, many centres throughout Europe are now equipped with 24-hour, seven-day-a-week PCI facilities and admit patients for immediate PCI. As these centres move away from thrombolysis completely, the future sales of our client’s agent are threatened. As a consequence, a clinical trial protocol has been developed to evaluate a pre-hospital optimised thrombolytic strategy for treating early presenting AMI patients.

Our challenge was to identify 250 appropriate investigational centres from across Europe and obtain qualitative information on their experience and treatment protocols. A critical success factor was that participating centres had to have an established infrastructure and good experience in both pre-hospital thrombolysis and immediate PCI.

Solution

Using online search engines we developed a database of around 800 candidate centres from across Europe to act as a resource for identifying centres and investigators with previous experience in similar studies. Contact information was obtained and verified through e-mail and telephone contact. A carefully crafted feasibility questionnaire was developed. Potential investigators from 20 countries were contacted and questionnaires completed. All responses and additional, relevant information were entered into a database and incorporated into a final report.
 
Results

The study was completed within three weeks. Based on the findings it was confirmed that a majority of centres treat AMI patients mainly with immediate PCI. However, a sufficiently large sample of centres who matched the study criteria was identified and confirmed the feasibility of the clinical trial.

 

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