A Look into the Life of an Investigational Drug

A new drug can be discovered in many different ways. If the drug shows promise to add, improve, streamline, or even cure a condition, it follows the same 5 steps to the approval process. The drug development process is strictly regulated by the FDA before any drug becomes available to the public. This rigorous, in-depth process will leave you with a newfound sense of appreciation that every possible angle has been looked at before you can buy a new drug.

Step 1 – Discovery and Development

  • Discovery- The way a new drug is discovered can include some of the following:
    • An existing treatment produced unanticipated effects, spiking interest in researching other uses for the compound.
    • New technology allows a targeted approach to specific sites in the body. This could allow more in-depth research on area-specific conditions and how a compound is affecting the condition.
  • Development- Once a potential compound is discovered, more information is needed, so experiments are conducted to gather data on how the drug is processed, what dosage is the best, and any side effects.

Step 2 – Preclinical Research

Prior to testing the drug on humans, researchers must find out whether or not the drug can potentially cause serious harm. The two types of preclinical research are in vitro, or in vivo. These are done under the required FDA good laboratory practices that set basic standards for study conduct, facility standards, and more.

  • In Vitro (means “in the glass”)- Performed with microorganismscells, or biological molecules.
  • In Vivo (means “within the living”)- Performed using whole, living organisms or cells like animals or plants.

Step 3 – Clinical Research

If a drug is deemed safe and effective enough to test on humans, the Investigational New Drug Process will begin. This process must be done before any clinical study is done. It starts with designing a clinical research study, which outlines what research questions hope to be answered, the purpose of the study, selection criteria for participants, dosage of the drug, and more.

Once the protocol is developed, an Investigational New Drug application and additional required data will then be submitted to the FDA. If approved, the clinical study process can begin with phase 1-4 clinical research studies. Data must be submitted back to the FDA review team during each phase, and once each phase is completed.

Step 4 – FDA Review

After the clinical studies are conducted and the drug determined to be safe and effective, a New Drug Application will be submitted to the FDA for approval to market the drug to the public. A few examples of what the application will include are:

  • How the drug will be labeled.
  • Safety information.
  • Data from all phases of clinical studies including preclinical results.
  • Dosage information. (Any variance to the originally approved amount requires a separate application.)

Oftentimes, the FDA will require additional information and work to refine the prescribing information before final approval is given.

Step 5 – FDA Post-Market Safety Monitoring

Up until this point, the safety and effectiveness of the investigational drug have been pitted against every possible known scenario. Once it is out in the public, the drug may face a new unknown scenario that may challenge that. This is why the FDA will continue to monitor the drug over its lifetime with any issues reported.

Cautions can be added to the labeling, dosage restrictions could be implemented and other interventions for more serious issues could result from the issues reported. In short, a drug will always be under an objective microscope as long as it is available to the public.

If this blog has piqued your interest in participating in a clinical trial, click HERE to find available studies in your area. Qualified candidates who participate will receive study-related care at no cost and receive compensation for travel.