The clinical trial process is a very regulated and oversight-intensive process. The Food and Drug Administration and the various Institutional Review Boards go to great lengths to ensure that the various research sites around the country are following the safety protocols put in place. Because while new drug development is extremely important to combat diseases, just as important is ensuring that this development is done in a humane and ethical fashion.
Clinical Research Trials LLC prides itself on its humane and ethical management of its numerous clinical research studies.
The clinical study process is broken down into a number of phases. While new drug development starts in the laboratory and then with animals, the human process is the most intensive and lengthiest of the development stages. Below is a brief breakdown of how the human stage is broken down.
Phase I- Phase I is the first study conducted on human participants. This stage tests the toxicity of the drug as well as helps conduct preliminary tests to determine proper dosages. The volunteer makeup is generally small with larger studies having less than 100 participants for Phase I research. Many times, participants are administered the drug and analyzed for a number of hours, or even days, to ensure that the participants are safe and not experiencing adverse side effects; and if they are, the clinical staff is on hand to ensure the participants receive immediate medical attention.
Phase II- Phase II of a clinical study is focused on determining how effective the drug is as well as finalizing any dosage questions left unanswered from Phase I. A participant in a Phase II study is typically already afflicted with the specific disease that the potential drug is meant to treat, except in the case of a vaccine being developed. A Phase II study will generally have 100-300 participants.
Phase III- Phase III is focused on confirming the effectiveness of the drug, finalizing any dosage questions still left unanswered after Phase II, and comparing the drug against similar forms of treatment. Typically, Phase III is expanded to 1,000-3,000 participants.
Phase IV- Phase IV studies are typically conducted after approval of the drug by the Food and Drug Administration for purposes of determining additional safety information or if the pharmaceutical company is considering marketing the drug for purposes other than those that the drug was initially approved for. Phase IV studies can last for up to 8 years and can therefore be very effective in assessing the long-term side effects of the approved drug.