PATIENT EDUCATION

A Drug’s Journey to
Your Medicine Cabinet

The steps involved to test a new drug for use

The pharmaceutical industry is working quickly to test a wide variety of potential cures for COVID-19. While drug makers have suggested a cure will be available by the end of the year, researchers are setting a timeline of 12 to 18 months to develop a vaccine. We asked, Mohammed Uddin, Albany College of Pharmacy and Health Sciences intern to explore the clinical trials and research development involved in drug development.

Microscope

The journey of an experimental drug from the laboratory into your medicine cabinet takes on average about 15 years. The researcher’s main goal is to find better ways to prevent, detect, and treat diseases. The first 6 to 7 years of drug development consists of researchers discovering a number of molecules that have the potential to become a drug for medical treatment. Once a molecule is identified by a researcher, it first goes through the preclinical testing period to ensure it is safe and effective in the laboratory and in animals.

Prior to testing the molecule in humans, researchers must find out whether the drug molecule has the potential to cause serious harm. If the results of preclinical testing determine the molecule to be safe and effective, researchers will then file an ‘investigational new drug application’ (IND). The IND must be approved by the Food Drug Administration (FDA) and by an institutional review board (IRB). The purpose of the IRB is to protect the safety and well-being of people who will be testing the new drug and to ensure ethical values are met. If the FDA approves the IND, this means the researcher may begin phases of clinical trials. Clinical trials are research studies that involve humans to test the new drug for safety and efficacy, and is typically done in a series of 3 steps:

Phase 1 Trials

This phase takes several months and includes about 20 to 100 healthy volunteers. The goal is to find a safe dose for the new drug, determine how the treatment should be given, and learn how the drug affects the body. If safety is determined, then the drug testing moves to the next phase.

Phase 2 Trials

This phase may take several months and up to 2 years and includes several hundred people with the disease or condition for which the drug is being developed. The goal is to further assess safety, but now also see if the drug actually works. If efficacy is determined, then the drug moves to the next phase.

Phase 3 Trials

This phase may take up to 4 years and may include several thousand people from patient populations for which the medicine is eventually intended to be used. The goal is to further assess if the drug works, but also to look at the long-term side effects of the drug.

If all 3 phases are successfully completed and the trials have shown the drug is safe and effective, then the researcher may file an application known as the “new drug application” or NDA. The purpose of this application is for the FDA to approve the researcher to begin marketing the drug for commercial sale. Reviewing of the NDA by the FDA can take up to 2 years. If the NDA is approved, the drug may be marketed with FDA regulated labeling.

After approval, a phase known as ‘post-marketing monitoring’ begins. Although clinical trials have shown the drug is safe and effective, it is impossible to complete long-term safety information by the time the drug is approved. After the public begins to use the medication, the researcher is responsible to submit safety updates such as side effects and other reports of issues or concerns to the FDA. The FDA will review these reports and may decide to add cautionary statements for use or if side effects are too serious, may withdraw the drug from the market.

New drugs are protected by patents when they are approved for marketing, which means no generic drugs can be manufactured until the patent expires. Although this process may be seemingly long, it is the only way to get the safest drugs to make it to your local pharmacy!

Written by Mohammed Uddin, Pharmacy Intern

References:
Drug Development Process [Internet]. [cited 2020Jun13]. Available from: https://ccts.osu.edu/content/drug-development-process
Learn About Drug and Device Approvals [Internet]. 2018 [cited 2020Jun13]. Available from: https://www.fda.gov/patients/learn-about-drug-and-device-approvals
The Drug Development and Approval Process [Internet]. [cited 2020Jun13]. Available from: https://www.fdareview.org/issues/the-drug-development-and-approval-process/