Time and money
Second tier efficacy tests can be relatively expensive and time-consuming. For instance, a human intervention study on blood cholesterol, on blood pressure or on elasticity of the arterial wall may take about one year, including the recruitment of volunteers and reporting.
One study will do?
Ideally, a second tier efficacy study should give a definitive answer. If for the main hypothesis to be tested a so-called primary outcome parameter is defined that is recognized as a beneficial effect or as a predictive marker thereof (a biomarker), if power calculations are adequate and if an effect is measured that is both biologically and statistically significant, one intervention study can indeed provide a definite, positive answer. But sometimes, at best, a trend towards a beneficial is observed that is not statistically significant. In most cases, more than one study is needed in order to prove an effect according to current standards.
Services provided for second tier testing may include, for instance, one or more of the following:
- selection of testing laboratories (based on considerable experience at lsbi with studies in vitro, in animals and in human volunteers)
- consulting with external experts to define an adequate way to measure an effect in the domain of choice
- in human volunteers, identifying the target population as well as methods to measure, for instance: blood sugar (fluctuations after a meal or baseline levels), gastrointestinal health, cardiovascular health, resistance to infections, body weight reduction or maintenance, lean body mass, bone mass, oral health, physical performance, mental performance or well-being
- in animals, for instance: quantify growth, normal behaviour, content of desirable nutrients, grade of produce
- monitoring of intervention studies or any other studies deemed necessary
- consulting with authorities
- further defining and building elements of a dossier for communication or for claim registration <hier graag een link plaatsen naar de desbetreffende webpagina>
- adapting the tentative time schedule towards market introduction, if necessary
- estimating overall feasibility and chance of success
- providing a basis for further decisions