Drug development is an essential process in the healthcare and medical industry. So much goes into creating safe and effective drugs to better treat different conditions and serve patients better.
According to the FDA, here are the steps for drug development…
Step One: Discovery and Development
In this step, the need for a new drug has been identified, and research begins in a laboratory. Researchers typically find new drugs when insights into a disease are found, existing treatments produce unanticipated effects, or technological advances create new avenues for development. The trial and error process begins in research to find compounds that are viable options for further research. When compounds are found promising, researchers continue to conduct experiments and gather information on the compound itself as well as how to produce it most effectively in drug form. The effectiveness and interactions with other drugs and compounds are also studied and observed at this stage.
Step Two: Preclinical Research
Testing involving people is taken seriously and can not be conducted until researchers are sure that the drug is safe. That is why in preclinical research, good laboratory practices (GLP) are used. These consist of rules to ensure ethical safety and requirements for quality testing and procedures. The results from testing at this stage determine if the product is safe to move on to clinical studies and patient testing.
This step answers the majority of questions about the realities of the drug and how it interacts with the human body. Even so, before public production and distribution can even be discussed, the research team moves on to the next step of clinical research.
Step Three: Clinical Research
As one of the most lengthy aspects of the drug development process, clinical research goes on for years. This step involves the testing of the drug with people. Developers design the studies around Clinical Research Phases and the Investigational New Drug Process (IND). These processes must be completed before human testers are involved. The IND application must be submitted to the FDA before clinical trials can start. All of the preclinical research and data, as well as information about the investigator and developers, must be included. The FDA will respond to the application and either approve clinical trials or place a clinical hold if requirements aren’t met.
There is a specific protocol and plan developed by researchers and manufacturers for clinical trials. This includes confirming participant numbers, groupings, and qualifications, drug dosage and administration, and data collection and analysis.
Clinical Trial Phases
Phase 1: The first phase involves a small number of qualified participants with the condition being treated. This stage lasts several months, and if the results prove successful, the drug moves on to phase two. 70% of drugs move on to the next phase.
Phase 2: This phase utilizes a larger group of people (sometimes several hundred) and will be carried out anywhere from a few months to over 2 years. The timing of this stage is dependent on the drug and determines the efficacy and side effects of the drug. As this phase is more in-depth and informative on how the drug will perform commercially, only 33% of drugs continue.
Phase 3: Anywhere from 300 to 3,000 people with the condition participate in this phase over one to four years to monitor efficacy and reactions. 25-30% of drugs continue to phase 4.
Phase 4: Several thousand volunteers with the condition are involved in this final phase to ensure the safety and efficacy of the product.
Step Four: FDA Review
Once the drug developer determines from all research that the drug is safe and effective, they will file an application to market the drug, which will be reviewed by the FDA review team. The New Drug Application (NDA) will include all of the data gathered from each step of the process up until this point as well as directions for use, labeling, patent information, safety updates, data from other studies, and drug abuse information. The review team is made up of individuals from different fields of medicine who will review all of the data, conduct clinical study site inspections, and assemble all reviews and reports as a record for FDA review.
When determining a safe and effective drug, the FDA will work with the applicant on narrowing down prescribing information (the “labeling” process). If the FDA requires more information or additional studies, they will address that with the applicant.
Step Five: FDA Post-Market Safety Monitoring
Continued monitoring of the drug and its safety will be in effect once public availability is established. This is conducted through supplemental applications, INDs for marked drugs, manufacturer inspections, drug advertising, active surveillance, generic drug manufacturing, and reporting.
As you can see, this process is extensive and lengthy. Between 30 and 50 drugs get approved each year on average. While this process takes a long time, it is important to ensure the safety of drugs and have total knowledge of side effects and how the drug interacts with the human body, environment, and other substances. All in all, drug design, testing, and implementation are essential in the healthcare industry as a whole and should be held with high respect and importance.