In order for a new cancer treatment to get approval from the FDA to come to market, it must go through clinical testing to ensure efficacy and safety for patients. After all, the first rule of medicine is “do no harm” and clinical testing helps to ensure this. Clinical testing can also help determine which types of patients respond best to the treatment so that it can be accurately prescribed.
You’re probably aware that the development cycle of a new cancer treatment is lengthy—in fact, it takes years to discover, develop and bring a new treatment to market. The good news is that clinical testing is the last stage needed to make this happen.
So, how do clinical trials work?
A clinical trial program consists of three phases of testing that must be completed before applying for product approval:
1. Is it safe?
A Phase 1 clinical trial determines if the treatment is safe and at what doses. This is often tested in a small group of healthy volunteers (usually 10-15). Sometimes patients with advanced cases of disease choose to participate; for example, if their other treatment options have been exhausted.
2. Does it have the intended effect?
Once the treatment has been determined to be safe, a Phase 2 clinical trial examines if the treatment affects the disease in the expected way. Are there any other side effects or effects on the body to take note of?
3. How effective is it?
In Phase 3 clinical testing, we know the treatment is safe and that it has some therapeutic benefit. But just how well does it work? And, how well does it work in comparison to currently available treatments? This phase will look at treatment efficacy in the most uniform group of patients possible. This will help to ensure that the results of the study can be attributed to the treatment and not another variable (e.g. patients having a different type or stage of disease, pre-trial treatment history or biomarker profile). This third phase will help determine whether the new treatment should be approved and marketed.
In some cases, there may also be a fourth phase of testing:
4. What are the long term effects?
Once a treatment is approved and is being marketed to patients, regulatory authorities may ask that one or more Phase IV clinical trials be conducted. This fourth phase of testing is also referred to as “post-marketing surveillance” because it keeps track of the treatment’s long term effects, including both the benefits and risks.
Did you know Oncolytics is currently conducting clinical trials of REOLYSIN in six of the ten most common cancers diagnosed in men and five of the ten most diagnosed in women? Check out a list of all our clinical trials in progress. We have conducted trials in Phases I through III in a wide range of cancer indications.