The development of new drugs for mesothelioma is critical, however, many steps must be taken to bring what begins as an investigational drug to final approval. This process is often slow, sometimes taking years before safety and effectiveness standards are met. Following are steps in the drug development process.
Step 1: Research and pre-clinical testing.
The drug undergoes basic laboratory and animal testing for safety and effectiveness. This step may take as long as four years.
Step 2: Investigational New Drug (IND) application.
The entity sponsoring the trial, for instance, a federal agency, medical institution, co-operative group or pharmaceutical company, must file an application with the Food and Drug Administration. If approved, clinical trials can begin. More on investigational new drug applications.
Step 3: Phase I clinical trials.
Phase I trials determine the appropriate dosage of the drug for use in humans, and also determines whether it is safe. It may take up to 2 years to enroll enough participants to evaluate whether the trial has been successful and can proceed to Phase II.
Step 4: Phase II clinical trials.
Phase II trials evaluate the effectiveness of the drug, as well as any side effects associated with its use. Again, this process may take up to two years. If the Phase II trial is successful, a Phase III trial is designed.
Step 5: Phase III clinical trials.
Phase III trials compare the effectiveness of the new drug against a standard of treatment. This phase can take up to four years to accrue enough participants. The results of Phase III trials are then reported at medical conferences and in scientific journals.
Step 6: New Drug Application (NDA).
Once adequate data has been gathered to support a certain indication, the trial sponsor files a New Drug Application with the Food and Drug Administration. This means the drug has been proven safe and is superior to the current standard of treatment.
Step 7: FDA Approval.
The Food and Drug Administration approves the drug, allowing it to be marketed to the public, and authorizing it to be “labeled” for a specific use. Labeling includes information on appropriate dosage, indications, safety and potential side effects.