Applying a business model based on marketing theory to clinical trials can give a consistent framework for planning and managing patient recruitment, say academics.
The need to overcome slow patient recruitment is driving the development of novel strategies, one of which is the adoption of business and marketing strategies. Although superficially very different, some believe business and clinical trials share many similarities.
Businesses strive to find customers and encourage them to buy what is on offer, clinical trials strive to find doctors and patients/volunteers and encourage them to sign up and stay on board, says the review published in the journal Trials.
The review looks at three studies, CRASH-2, TXT2STOP and LIFELAX, which used the business model to develop clinical trial processes, for diagnostics and as an audit tool respectively.
In the TXT2STOP trial, a study of smoking cessation support via text message, application of the business model resulted in a new conceptualisation of recruitment. This recognised the trial was being promoted to three distinct groups: directly to smokers; primary care teams; and smoking cessation services.
Recognising these groups led to the trial team identifying factors which would encourage them to participate and, conversely, elements likely to put them off. After adopting a strategy based around this knowledge the trial recruited 4,744 participants in 10 months; prior to the shift 1,056 had been recruited in eight and a half months.
The business model was proposed in a 2007 Trials paper. In the paper clinical trials were broken down into four units: building brand values; product and market planning; making the sale; and maintaining engagement.
Each unit, which includes three sub-units, uses business terminology but can be applied to the process of recruiting patients to a clinical trial. For instance, the building brand values component conveys what the trial 'stands for' to potential participants and collaborators.