As an integral part of healthcare research, clinical trials are conducted to assess the safety and efficacy of potential new drugs and medical devices such as new diagnostics. These studies comprise part of the development component in healthcare research. Furthermore, clinical trials are required by Federal agencies to approve and license new drugs and devices.
There are multiple progressive phases in clinical research. Phase I studies typically involve a small number of healthy volunteers. This phase is closely controlled to monitor how the drug is absorbed and distributed in the body. Physicians are also carefully examining the patient for adverse reactions to the new drug.
Phases II and III enroll patients with the disease that the drug is intended to treat. These studies are completed in collaboration with physicians and research groups experienced in conducting clinical trials. If the phase II safety and efficacy results look promising, the phase III trials are then completed in much larger disease populations with considerably more physician research centers. Phase III studies are the largest component to clinical development in terms of patient numbers, study centers and study costs.
Finally, in some instances, the pharmaceutical company or regulatory authorities require Phase IV or post-marketing studies to address new or specific issues that weren't identified in the earlier trials.
In general, clinical trial design involves integrating information from various departments within the company, following the requirements of local and federal regulatory agencies and complying with the ethical guidelines set forth by committees for human rights. The role of Phenomenome's clinical trial team is to bring Phenomenome's research discoveries from the laboratories to the clinic and ultimately into standard care medicine.