There are more than 15 million cancer survivors in the U.S. today. Every day, new treatments help more people successfully fight cancer to live longer lives. Many of those patients have been saved because of clinical trials.
Every medical breakthrough and cancer treatment started as a clinical trial. Research studies give us the power to transform scientific research into better ways to prevent, diagnose and treat cancer. But the path from drug inception to widespread market availability is by no means an easy one. On average, it takes 10-15 years and $2-3 billion to develop a single drug that is effective and suitable for human use.
Drug Discovery and Early Research
There are years of work that must happen before a drug is given to a patient. The initial laboratory and research process can take an average of seven years. The discovery phase generally starts with 10,000 – 20,000 combinations of drugs to target a disease, with only 1 to 5 of those moving forward to further testing. For a drug to move into a clinical trial it needs to:
- Look very promising in the lab
- Demonstrate safety in animal studies
- Be clear how the drug is given (whether it's a pill or IV) and how it's absorbed
All of these things are studied extensively before a drug enters a clinical trial.
The People Factor
Clinical trials are conducted to understand how a certain approach (treatment, test, etc.) affects the people who receive it. Participation in a clinical trial is completely voluntary and the patient’s best interest always first and foremost. The benefits, risks and the purpose of the trial is always fully explained.
On a clinical trial, a patient’s care team is comprised of expert physicians, nurses and technicians. They assess every lab, medicine and symptom to carefully examine the impact on the patient, care and outcome. Further protection during a trial is assured through scientific reviews, institutional review boards, data safety and monitoring boards, and FDA inspections.
Clinical Trial Phases
There are generally four phases of clinical trials that build on one another to learn more about the treatment:
Phase I – Is the treatment safe?
This phase typically involves 20-30 participants with goals of assessing:
- How well a drug or procedure can be tolerated in people
- The best dose, schedule and delivery
Phase II – Does the treatment work?
This stage involves a larger group of dozens of people. It determines if the treatment is impacting the specific area or tumor, while still monitoring safety.
Phase III – Is it better than standard of care?
With hundreds to thousands of participants, this phase compares the safety and effectiveness of the new treatment against the current standard treatment.
After the third successful phase of clinical trials, the drug’s manufacturer or sponsor is ready to submit a new drug application (NDA) to the FDA. This requests approval to market the drug in the general population.
Phase IV – Is the treatment safe over time?
Often occurring after FDA approval, it puts the treatment into the hands of a large number of people, while still ensuring patients are monitored for any long-term effects.
The Sarah Cannon at HCA Midwest Health Impact
Through our clinical trials program, Sarah Cannon and HCA Midwest Health are ensuring patients in our communities have convenient access to cutting-edge treatments. Clinical trials not only benefit the patients of today, they also make possible the discoveries that may save lives in generations to come.