Phase III Clinical Trials Confirm Effectiveness of Treatment
The chief medical officer of Trek Therapeutics based in Cambridge, Massachusetts, Robert Hindes, MD, manages clinical trials involving the company’s hepatitis C antiviral drugs. These include the NS5A inhibitor TD-6450, the protease inhibitor faldaprevir, the nucleoside polymerase inhibitor MIV-802, and the non-nucleoside polymerase inhibitor VX-222. Under the supervision of Robert Hindes, MD, combinations of these drugs are currently being evaluated in Phase II clinical trials.
After initially evaluating the safety and efficacy of a treatment in Phase II clinical trials, drug companies must use Phase III trials to confirm the effectiveness of the drug using statistically powered study designs. While Phase II trials often include several hundred participants, Phase III trials often require thousands of subjects in order to establish statistically meaningful data on the drug’s safety and effectiveness. Due to the expanded scope, Phase III clinical trials typically take several years to complete.
An important objective of Phase III trials involves establishing the effects of a drug or regimens on people from different demographic backgrounds. Effects of a drug can vary widely based on the age, ethnicity, and gender of a patient, as illustrated by the heightened sensitivity of Asian populations to the anticoagulant warfarin. As such, it is critical for Phase III trials to include a variety of subjects to determine any differences in side effects, tolerability, or efficacy.
After initially evaluating the safety and efficacy of a treatment in Phase II clinical trials, drug companies must use Phase III trials to confirm the effectiveness of the drug using statistically powered study designs. While Phase II trials often include several hundred participants, Phase III trials often require thousands of subjects in order to establish statistically meaningful data on the drug’s safety and effectiveness. Due to the expanded scope, Phase III clinical trials typically take several years to complete.
An important objective of Phase III trials involves establishing the effects of a drug or regimens on people from different demographic backgrounds. Effects of a drug can vary widely based on the age, ethnicity, and gender of a patient, as illustrated by the heightened sensitivity of Asian populations to the anticoagulant warfarin. As such, it is critical for Phase III trials to include a variety of subjects to determine any differences in side effects, tolerability, or efficacy.
