How Clinical Research Training Fits into the FDA’s 5-Step Drug Development Process

Graduates of a clinical research program know how vital research is to the FDA’s 5-step process

Graduates of a clinical research program know how vital research is to the FDA’s 5-step process

Every year, new drugs are put on the market with the intention of providing relief for suffering patients. These drugs have gone through years of research, testing, trials, and applications in order to be approved. Therefore, patients have some assurance that the drugs on the market meet certain safety and quality standards.

To make that assurance, the Food and Drug Administration (FDA), much like Health Canada, uses a five-step drug development process. If you’re interested in a clinical research career, it is important to know each step in the process, as there is frequent collaboration between both governing bodies. Read on to learn about each FDA step.

Professionals With Clinical Research Careers Know the First Step Is Discovery and Development

The first step to creating a new drug is the discovery and development process. For the discovery portion of the process, new insights and technologies are taken advantage of to test against a large number of diseases. The list of compounds that may be candidates for treatment is whittled down until only the few most promising ones are sent into development. Development, as any clinical researcher knows, involves conducting experiments to determine how the drug is absorbed and distributed throughout the body, as well as its benefits, side effects, and effectiveness.

Step 2: Preclinical Research

Professionals with clinical research careers know that the second step is the preclinical research phase. During this step, the toxicity and potentially harmful nature of the drug are tested. The drug can be tested in vitro (in a test tube) or in vivo (in a living organism). Animal testing may be conducted at this stage as well. Regardless, all testing in step two needs to meet the basic requirements for operating protocols, reporting, facilities, equipment, and conduct. These studies determine whether the new drug reaches the third step of development.

As professionals with clinical research careers know, the second step for the FDA is preclinical research

As professionals with clinical research careers know, the second step for the FDA is preclinical research

Clinical Research Training Prepares You for Step 3: Clinical Research

The middle phase in the FDA’s drug development process is the one that clinical research professionals have the biggest part in. In this phase, clinical research and clinical trials are conducted on human patients to determine if the drug is safe, effective, and worthy of hitting the market. Generally, this step will involve multiple different phases of clinical trials. In the US, the first phase may involve 20 to 100 patients and can last a few months. Each successive phase (up to 4) will grow larger and longer in scale. In Canada, however, this step is completed a little differently and there are three phases outlined distinctly for each new drug.

Grads of Clinical Research Programs Know How to Prepare For Step 4: FDA Review

As any graduate with clinical research training knows, the penultimate step of the process involves collecting all research information—studies, data, and reports—and submitting it to the FDA in a formal application to market the drug. Health Canada also follows this step, with a similar application process.

During this step, researchers must indicate what labeling would be used, as well as directions for proper use. Following that, the governing body conducts a thorough review of the material, which can last from 6 to 10 months.

Step 5: FDA Post-Market Safety Monitoring

The last step is one in which the FDA has a partnership with Health Canada in order to ‘harmonize and align their pre and post-marketing surveillance requirements and standards.’ As clinical researchers know, these governing bodies inspect the manufacturing processes for each drug to make sure they are up to standard. They also make sure that all advertising is legitimate and that any changes to the drug—toxicity, dosage, new form, etc.—are requested through a supplemental application process and have legitimate clinical research to justify the change.

Have you been thinking about starting a clinical research program

The final step in the FDA’s 5-step drug development process is post-market safety monitoring

Much like Health Canada’s drug development process, the FDA’s 5-step drug development process is meant to ensure that all drugs on the market meet the same standards of safety and quality. To do so, clinical research is a vital part of the testing, trial, and application process.

Have you been thinking about starting a clinical research program?

Visit AAPS for more information or to speak with an advisor!