"The ACTRI is part of a national
Clinical and Translational Science Award (CTSA) consortium created to accelerate laboratory discoveries into treatments for patients by facilitating research resources for all investigators. The CTSA program is led by the
National Institutes of Health's National Center for Advancing Translational Sciences (NCATS).”
In order to evaluate and improve our efforts to advance translational research, the ACTRI has adapted and embraced the multi-T phase concept of translational research, described below.
Definition of Translational Research
Translational research involves moving knowledge and discovery gained from the basic sciences to its application in clinical and community settings. This concept is often summarized by the phrases "bench-to-bedside" and "bedside-to-community" research .
T-Phases of Translational Health Research
As the concept of translational health research has evolved with practice and time, it is clear that translational research encompasses a bidirectional continuum. For didactic purposes, translational research has often been described in phases of translation, or "T-phases." The ACTRI has adopted a model of 5 phases (T0-T4), adapted from Khoury et al. :
Example of T0-T4 Translational Health Research
Identification of opportunities and approaches to health problem.
|Basic research question||Are there specific gene mutations associated with breast cancer?|
|Discovery of candidate health application||Phase I and II clinical trials; observational studies||Is there an association between BRCA mutations and breast cancer?|
|Health application to evidence-based practice guidelines ||Phase III clinical trials; observational studies; evidence synthesis and guidelines development||What is the positive predictive value of BRCA mutations in at-risk women?|
|Practice guidelines to health practices||Dissemination research; implementation research; diffusion research Phase IV clinical trials||What proportion of women who meet the family history criteria are tested for BRCA and what are the barriers to testing?|
|Practice to population health impact ||Outcomes research (includes many disciplines); population monitoring of morbidity, mortality, benefits, and risks studies||Does BRCA testing in asymptomatic women reduce breast cancer incidence or improve outcomes?|
Reproduced with permission from the
Institute of Translational Health Sciences.
Khoury MJ. et al. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genomic discoveries into health care and disease prevention? Genet Med 2007:9(10):665-674.
ACTRI Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies of human subjects that are designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases:
- Phase I. Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
- Phase II. Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
- Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the interventions to be used safely.
- Phase IV. Studies conducted after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
All clinical trials research supported by the use of ACTRI services must be peer reviewed.