Northeast Clinical Trials Group
Northeast Pennsylvania's Resource for Medical Research
570-504-5507
Research Process
Clinical research is a very long process that starts long before NECTR is involved.
The process is as follows:
1. Discovery- This step takes ideas and makes them into realities. This step allows scientists to make new drugs, vaccines and devices that may change people's lives. This years can be several years or an "Aha!" moment.
2. Preclinical Development- This step is where dosing models are developed and the new treatment begins to be "fine tuned". This process often takes 3-5 years.
3. Clinical Phase- This portion of research is when human subjects are used to test the new treatment. The testing and analysis can take over 10 years to complete.
Prior to testing in human subjects, all new treatments, whether they are cosmetics, drugs, vaccines, or devices must be filed with the U.S. Food and Drug Administration (FDA) and given approval for testing.
Strict guidelines (GCP, ICH, State and local regulations) are followed for all subjects involved in clinical research.
All research subjects must be informed and consent to their decision to participate in clinical trials. NECTR follows strict guidelines for conducitng Informed Consent Processes in order to keep our subjects informed of the risks and potential benefits of participating in our studies.
Clinical Trial Phases:
Phase I Clinical Trials- This phase of clinical trials focuses on SAFETY. Healthy subjects participate in this phase and are given low doses of the treatment to ensure there is little-to-no risk involved in continuing with treatments. These subjects are watched very closely by physicians to see how they react to the new treatment (if the compound is sufficiently absorbed, how long the compound remains in the bloodstream, and which dosages are safest)
**NECTR does not conduct any Phase I trials
Phase II Clinical Trials- This stage of clinical trials focuses on EFFICACY. How well a new drug or device will work to treat/prevent an illness or medical condition. This is also where dosing is perfected. The subjects for Phase II studies are drawn from hospitals and research centers accross the Country and around the World. There are usually about 100-300 subjects involved in Phase II studies but this can vary depending on the type of study. These subjects are in need of the treatment offered and will meet strict guidelines for participation in the study (Inclusion/Exclusion Criteria)
Phase III Clinical Trials- In this final stage of clinical trials, the research is focused on CONFIRMATION of previous studies. The population for this phase tends to be quite large, usually 3,000-10,000 patients. The large number allows researchers to see how different populations are affected and how rare adverse effects (issues) may appear in those populations.
Phase IV Clinical Trials- These are commonly called "Post Marketing" studies as these products have been approved by the FDA and are available to the public. These studies provide additional data and focus on SATISFACTION of the product
