New drugs are typically developed through a series of clinical trials in the modern pharmaceutical industry. These trials are designed to test the safety and efficacy of a drug in humans. The biopharmaceutical industry in the United States was worth $1.4 trillion in 2020, according to PhRMA. It’s a vast number, but it doesn’t tell the whole story.
Getting a drug from the lab to the shelf is long and arduous, with no guarantees for success. This article will provide an overview of what happens during each phase and why it takes so long for a drug to reach your local pharmacy.
How Long Is the Drug Development Process?
It’s a lengthy and complicated process. Biotechnology Innovation Organization’s research shows that it takes an average of 10.5 years for a Phase I program to progress to regulatory approval. It costs pharmaceutical companies billions of dollars. It also involves many regulatory hurdles, as the FDA is responsible for regulating all drugs in America, from their initial creation to their final distribution.
The medical industry is constantly changing and evolving. New drugs are being invented every year that have the potential to change the face of medicine forever; however, these innovations will not be helpful unless they undergo rigorous testing and research before they can be approved by federal agencies such as the FDA or CDC.
Drugs are developed in several stages, preclinical, clinical trials, and post-marketing surveillance. Each stage requires the use of special equipment and sterile environments called cleanrooms. Pharmaceutical cleanrooms ensure that the drugs are produced in a safe and sterile environment, without contamination from outside elements.
Some companies even use laser cleanrooms to mark the drugs for better efficiency. These cleanrooms help manage the laser beams without harming or contaminating the drugs. Laser cleanrooms are also used to drill holes in pills and perform other processes that require precision in small spaces.
Preclinical Studies
Preclinical studies are conducted in animals, usually mice or rats. They are used to test the safety and effectiveness of a drug before it is tested in humans.
In these tests, the researchers look at how a drug behaves in different parts of an animal’s body. They also find out how much of that drug gets into the bloodstream and how long it takes to leave the body.
Phase 1 Trials
Phase 1 trials are the first trials that test a drug’s safety in humans. In these studies, conducted in a small group of 20-80 healthy volunteers, researchers determine whether a drug candidate can be absorbed and transported to tissues throughout the body. They also look for signs of toxicity (harmful side effects) at different doses.
Phase 1 trials last about six months and do not involve any comparison between healthy volunteers and those with cancer or other diseases. Therefore, Phase 1 results cannot determine if a new drug might be effective against cancer or another disease; they only provide information about its safety as part of routine medical care.
Phase 2 Trials
Phase 2 trials are designed to determine the safety and effectiveness of a drug in a larger group of people. They also allow researchers to evaluate whether the treatment caused any adverse side effects and, if so, how they can be prevented or managed.
Phase 2 trials usually involve several locations for testing purposes and a randomized assignment into treatment groups. Additionally, many phase 2 studies are double-blinded—that is, neither participants nor researchers know who is receiving active medication versus placebo until after data collection has been completed.
Pharma Intelligence says Phase 2 development is the most significant hurdle in drug development. Only 28.9% of candidates make it through this phase.
Phase 3 Trials
Phase 3 trials are the final testing stage before the FDA approves a drug. These are the most extensive, expensive, and important phases of clinical trials. The purpose of phase 3 trials is to confirm that the drug works and is safe in a larger population compared to previous studies.
The main goal at this stage is to obtain enough information about how much benefit patients can expect from taking a new medicine. There may be more than one trial at this stage, but each will use similar methods so that results can be pooled together for comparison purposes.
FDA Approval
Approval by the FDA is the final step in the drug development process. The US Food and Drug Administration approved 50 new drug therapies in 2021.
Drugs are approved based on results from clinical trials and their risk-benefit profile. Approved drugs are considered safe and effective, while unapproved drugs are considered unsafe or ineffective. Once the FDA has approved a drug, it can be prescribed to patients with a disease or condition that has not responded to other treatment options (e.g., surgery).
Post-Market Approval Studies
Post-market approval studies are conducted after a drug has been approved by the FDA and released to the public. These studies aim to monitor how well a drug works in real-world settings and any side effects that were not discovered during clinical trials.
Some examples of post-market approval studies include:
- A study designed to monitor whether or not there are any severe side effects (as opposed to minor ones) caused by taking a certain medication over an extended period.
- A study was designed to see if taking two medicines together will have more positive effects than taking either alone.
Conclusion
Drug development may take 10-15 years and cost $1 billion or more, as confirmed by a study published in The Journal of the American Medical Association. It has many phases, each of which must be approved by the United States Food and Drug Administration (FDA).
In the end, there is no perfect drug development process. There will always be problems and challenges to face, promising drugs that end up being ineffective or dangerous and costly drugs that never make it out of the development phase. The key is understanding the basic steps involved in this process and preparing as much as possible for the future.
For more information on how your medicine is made, check out the infographic below!
Infographic provided by The Emmes Company, a biostatistics organization
