Since the World Health Organization deemed COVID-19 a pandemic in March, scientists, doctors, and pharmaceutical experts have been scrambling to develop treatments and vaccines. With more deaths every single day, and no well-established immunity to the novel virus, people around the world are anxiously awaiting the protections that pharmaceutical drugs may provide.
So what exactly is the timeline to bring a new COVID-19 drug to the market? President Trump has optimistically predicted a vaccine by the end of 2020, but many experts disagree. The truth is that the development of a pharmaceutical drug is a complex, intricate process that requires time to ensure safety.
The Normal Timeline of Bringing a Drug to Market
Thanks to stringent oversight by the FDA, every drug must undergo rigorous testing, trials, and analysis before it’s deemed suitable for patients. This isn’t a quick process by any means, and in fact, time is the key to success.
Most drugs average ten years from inception to FDA approval and marketing. The process begins with basic research, drug discovery, and pre-clinical research in animals or petri dishes. These initial steps alone may take months or years.
Once a potential new medicine has proved its promise to help human patients, it enters the first of three phases of clinical trial research:
- Phase 1: Evaluate the safety of a drug or medical device using a small number of healthy volunteers. Overall, researchers design Phase I to identify how the drug is absorbed, metabolized, and excreted. About 70% of all clinical trials pass Phase I and receive FDA approval to move into Phase 2.
- Phase 2: The same drug is given to a larger group of people, usually up to 300 participants. Instead of focusing only on safety, Phase II trials gather data on the drug’s efficacy. Only about 30% of all clinical trials pass Phase I and Phase II for approval of Phase 3.
- Phase 3: A Phase III trial is much larger than the phases before it. Most Phase III trials enroll thousands of volunteers to collect, confirm, and assess the following information about the experimental treatment. This includes the drug’s efficacy, side effects, performance, safety factors, and benefits. Phase III trials may last for years.
Finally, a successful Phase 3 trial leads to FDA review and possible approval for marketing to consumers.
Pharmaceuticals Seek to Compress COVID-19 Drug Development Timeline
In the face of the COVID-19 pandemic, ten years is far too long to wait for a treatment or vaccine. This is exactly why scientists and pharmaceutical teams are committing incredible resources to compress the drug development timeline and unveil coronavirus drugs in only a fraction of that time.
The Coronavirus Treatment Acceleration Program (CTAP) is an FDA special emergency program developed to fast track promising COVID-19 treatments and give them to patients as quickly as possible, while also gathering data regarding safety and efficacy.
CTAP is using the following methods to accelerate drug development timelines:
- FDA response within one day to developers and scientists seeking to develop new drug or therapy
- Ultra-rapid, interactive input on development plans
- Protocol review within 24 hours of submission
- Completed review of single patient expanded access requests around-the- lock, generally within 3 hours
- Expedited quality assessments for products to treat COVID-19 patients and transfer manufacturing to avoid supply disruption
These methods may shorten the standard timeline required for drug development, but they can’t change the fact that appropriate phase 1, 2, and 3 clinical trials are critical to successful, safe drug approval.
Which Drugs Are On the Horizon?
As of May 11, 2020, 144 active trials of therapeutic agents for COVID-19 are in progress, with more than 450 development programs for therapeutic agents in the planning stages.
The initiatives at Oxford University, Johnson & Johnson, and Gilead have received a great deal of media attention for moving faster than other drug efforts. Only time will tell whether they receive the FDA seal of approval needed to enter the market. Though it won’t take ten years, it’s possible that Americans could be waiting for a coronavirus treatment or vaccine until the end of 2021 or beyond.