Intervention research or clinical research involving human subjects meets a precise specifications according to the principles of Evidence Based Medicine. It relies on a particular experimental protocol called randomized controlled trial or clinical trial phase 3 This experimental applied research aims to demonstrate the effectiveness of a treatment strategy or action health prevention with a level of statistical power and a statement of side effects in humans, and that in respect of a national and international ethical framework.
The study participants were randomly assigned to one of two groups (the simplest case), a group testing innovation (non-pharmacological treatment, medical device, new technology development) and a control or placebo group. Individuals can participate in a study if they meet the criteria for inclusion (eg, greater than 70 years old) and the criteria for non participation (eg presence of cardiac disease). If the group testing innovation receives on average statistically superior results to the control group on several measures of effectiveness, safety, satisfaction and quality of life, then the evidence of the superiority of innovation compared to the control group become irrefutable. These studies provide rich data on how to manage innovation. These protocols are framed at the regulatory and ethics.
Observational Research vs Interventional Research
Observational research as its name suggests tracks changes in individual and collective trajectories seeking to identify the factors behind the change in trajectory. In contrast, intervention research designed to act on a particular issue and change over time. There is no opposition but a complementarity between these two methodological and epistemological ways. The first notes improvements in health, survival and quality of life for people who have undergone therapy or preventive action. It can also observe additional benefits to families and relatives and even save money. However, it does not provide irrefutable efficiency and cost / effectiveness evidence, it just provides a proof of concept. The second relied on the randomized controlled trial where possible, reflects the power of a therapeutic or preventive health innovation to a targeted population.
Current budget limitations in health and growing expectations of improved quality of care will impose severe arbitrage therapeutic priorities. These choices will be increasingly based on impeccable scientific and medical evidence rather than on clinical intuition, on mechanistic studies or cohort analyzes. We have never been a greater need to demonstrate and compare the cost / effectiveness of health innovations.
The General Message
Without intervention research, there would be no evidence that a therapeutic strategy or a health care prevention is better than another for patients or those at risk vis-à-vis their health.
What it means for Health Professionals
The findings of intervention research provide a framework for effective health professionals. This does not invalidate the clinical sensitivity of health professionals concerned. The latter must naturally be adjusted to the needs of the intervention each patient. Intervention research provides guidelines for users, people with health risk and chronically ill. She finally gives data to researchers to conduct meta-analyzes.
What it means for Researchers
Interventional research test with sufficient population from a calculation of the number needed if the mechanisms are in action at the selected dose. Blog on Health recommend reading the site Michel Cucherat CNRS and the Faculty of Medicine of Lyon for details.
What it means for Policymakers
Intervention research builds on previous fundamental research highlighted action underlying mechanisms in animals and/or humans. It provides invaluable data on how to manage innovation, its adverse effects, reports profit / risk situations as they arise and its cost / effectiveness ratio.
Cucherat M (2013). Web site (in French).
To reference this Blog en Sante © article.
Ninot G (2014). Definition of behavioral clinical research. Blog en Sante, L6.
© Copyright 2014 Grégory Ninot. All rights reserved.