Clinical Research, such as all human activities, can be victim of mistakes; shorter and shorter times, competition between companies and business needs, often push to skip steps, conducting preliminary analysis and assessments not always adequate and complete. Most of the problems related to the studies conduction depend on methodological criticism and issues, resulting in a waste of time and resources. This is proven, for example, by the increasing number of substantial amendments: the need to change a protocol, is often synonymous of deficiencies and inaccuracies in the initial documentation submitted to the competent authorities increasing the risk of a poor quality of data collected and highlighting the weakness of the study rational and objectives.
The methodological rigor in planning, conducting, analysis and reporting the study phases, aims to minimize the risk of issues by acting on the main critical areas such as:
- Study rationale (ability to transform a clinical need into a clinical trial)
- Primary and secondary endpoints definition
- Identification of the appropriate experimental design
- Definition of the number of patients to be enrolled and the inclusion and exclusion criteria
- Randomization procedures and blindness
- Analysis populations definition
- Interim analysis planning
A study results can be stronger if the study does not present systematic errors, errors that can be avoided (or reduced) putting the attention on the study design phase. The world of Clinical Research will always have to deal with uncertainty: we cannot avoid the unpredictable risk of an investigational drug and we cannot guarantee its absolute effectiveness on the entire population. To contain the uncertainty factors, we must act on the unpredictability elements, minimizing errors frequency and severity; to do this, the main resource is the methodological approach in the planning phase of a new study to evaluate the new treatment through correct and rigorous trials.
PRINEOS has the aim to operate to improve the efficiency and effectiveness of clinical research by carrying out an analytical and critical approach to properly answer to the fundamental questions (epidemiological, diagnostic, therapeutic, prognostic) that characterize each clinical study: is the study scientifically valid? Are study results clinically relevant? Are study results applicable to clinical practice?