Our Science
Clinical Trials
Accendatech is devoted to the development of anti-cancer trug. Clinical trials is essentian to gaining regulatory approval for new medications.
If you are interested in participating in a Accendatech clinical trial and would like to contact someone, please email contact@accendatechusa.com. If you are already participating in a clinical trial and wish to report a problem with the study drug or side effect(s), please contact your study doctor as soon as possible.
About Research and Development and Clinical Trials
Pre-clinical testing is conducted in the laboratory and often in animals to evaluate the safety, efficacy, ways of administration, and other properties of the investigational drug.
Once pre-clinical testing has been completed, an Investigational New Drug (IND) application is submitted to the FDA. Afterwards, the FDA will evaluate the investigational drug for safety to assure that human clinical trials participants will not be subjected to unreasonable risks.
A clinical trial is a research study done to evaluate new potential treatments in people. During a clinical trial, information is collected to determine if a study drug is safe and effective, as well as to evaluate the risks and benefits of the study drug. For more information about clinical trials in general, please see
ClinicalTrials.gov
.
Human clinical trials are conducted in four phases. Each trial phase has a different purpose and helps answer different questions:
- Phase 1: A study drug is tested in healthy people, often in volunteers without disease for the first time to evaluate its safety and to gain insights into the best ways to administer the drug.
- Phase 2: The study drug is tested to determine a safe dose or range of doses, to further evaluate its safety, and to begin testing in subjects with the disease of interest to determine if it has the intended or predicted effects.
- Phase 3: The study drug is tested, often in larger trials of longer duration to confirm its effectiveness and to further evaluate safety. Phase 3 trials often compare the study drug to commonly used treatments (if any) or to placebo treatment, if it is scientifically and ethically appropriate to do so.
- Phase 4: These are post marketing studies, and are performed after regulatory agency approval. These studies are designed to collect additional information including drug’s risks, benefits and optimal use in a broader patient population, often over extended periods of time.
After phase 3 clinical trial is completed, a Marketing Application is submitted to regulatory agencies. The Marketing Application contains all data gathered about the safety and effectiveness of the drug from the preclinical studies and clinical trials that have been performed. The Marketing Application also contains information about the chemistry, toxicology, pharmacology and manufacturing processes of the product. The regulatory agency reviews the data and, if approved, the new treatment can be marketed and distributed to the public through prescription by a qualified physician.
Clinical Trial
