Biotech Clinical Trials & FDA Approval

Biotech clinical trials are carefully controlled research studies conducted on humans to test the effectiveness and safety of new drugs, medical products, or treatments. Before a company can initiate any biotech clinical trials (i.e. testing on humans), it must conduct extensive experiments on animal and human cells, and in live animals. If this stage of testing is successful, the company files an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to request permission to conduct biotech clinical trials. All drugs in the United States undergo three phases of clinical trials before gaining FDA approval for general use:

• Phase I biotech clinical trials are the first evaluations to determine the safety, dosage range, or side effects of new drugs or treatments. Phase I trials are usually conducted among a small group of people (20-80).
• Phase II biotech clinical trials are conducted on a larger group of people (100-300).
• Phase III biotech clinical trials are then conducted on an even larger group of people (1,000-3,000). Phase III trials are used to confirm effectiveness, monitor side effects, and compare the drug or treatment to commonly used treatments.

Once a company has obtained a New Drug Application (NDA) from the FDA and has begun marketing its new drug or treatment, it may undergo a fourth biotech clinical trial phase. These studies determine the effect of the drugs or treatments in various populations, and monitor any side effects from long-term use.

FDA approval is not something to take for granted. About 95% of drugs fail in development. The drug discovery process is a long distance journey with many hurdles. Drugs must be potent, specific and convenient to take — much easier said than done. We make huge demands on these companies to design a small molecule that can be taken by mouth, survive the stomach, reach the bloodstream and last long enough to kill the invading bug, and at the same time cause no side effects.

In some cases, patients are given access to drugs or treatments that have not yet gained FDA approval. IND protocols give people with life-threatening diseases access to new drugs when no good alternative treatments exist.

FierceBiotech is a free daily email newsletter that keeps you up to speed on important biotech clinical trial developments, drug pipelines, and FDA approvals. We pay special attention to the business side of biotech clinical trials. The newsletter tracks advances in pharmacogenomics and screening techniques, venture capital investments in drug development companies, key initiatives from the NIH (National Institutes of Health) and other organizations, and companies’ efforts to advance their clinical trials pipelines and bring new drugs and treatments to market.

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