Part 1: What is a Clinical Trial?

You may have heard of cancer clinical trials before. Pharmaceutical companies trick you into testing out this new drug so they can make lots of money while treating you like a lab rat, right?
Wrong.

A clinical trial is a research study involving people that tests new therapies for cancer. Clinical trials are often misunderstood. Before a treatment goes to trial in the first place, it has to pass rigorous standards of research and years of testing in a lab and on animals.

Clinical trials are also the only way that new therapies can be approved for market in the United States. People sometimes fear that participating in one means taking a chance on risky care, but the trials often represent the newest treatments and highest standards of care available. A cancer clinical trial is the environment in which new cancer therapies are proven for their effectiveness. All medicines and treatments we currently use in the healthcare industry were once tested in a clinical trial after years of development in research labs. If not for this research process, we may not have Gleevec (sometimes used to treat Leukemia), the HPV vaccine, Avastin for non-small cell lung cancer, or Xalkori for ROS1 and ALK mutations, — some of the best cancer treatment drugs available today.

Without the clinical trials process, we would have no way of proving that medicines such as these are safe or effective. Patients who participate in clinical trials have the opportunity to access and potentially benefit from these therapies early and to help prove or disprove their use for future generations of patients.

As a trial participant, you not only benefit from these new treatments, but you also contribute to the body of knowledge that advances the cures for different types of cancer.

Here’s the (simplified!) process of how drugs pass through clinical trials:

  1. A new drug is tested for years in a research lab and shown to have a marked benefit as a cancer treatment.
  2. This drug is then brought to trial and is tested in three different phases. (See part two of this blog post series to learn about these phases.) Most trials in the US are monitored by an Institutional Review Board (IRB), composed of doctors, statisticians, and laypeople. The job of this board is to ensure that the rights of participating patients are protected, that the risks of the new treatment are low, and the benefits are worth it.
  3. The physicians administering the trial carefully test dosages of the drug as well as combinations of treatments to find the most effective way to combat a particular type of cancer.
  4. The trial gathers a large enough pool of participants to show whether the drug is an effective treatment across a broad spectrum of cancer patients.
  5. The trial submits their research analysis to the FDA (Food and Drug Administration) for approval to sell this drug on the market.
  6. Millions of cancer patients benefit from this new treatment.

It’s important to note there is no guarantee that a new treatment will work and unknown or negative effects are possible. But all clinical trials are required to treat their patients with the highest standards of care.

The truth is that clinical trials make it possible for patients to receive top-notch, cutting-edge treatments. When we do find the cures for different cancer types, it will be through the data acquired from clinical trials. To learn more about cancer clinical trials, check back for Part 2 of our Clinical Trial blog series, focusing on the phases of clinical trials, or visit our clinical trials awareness page to gain access to our ebook, ‘5 Things You Need to Know About Clinical Trials & Precision Medicine.’

If you found this post to be helpful, please feel free to share it with others who may have questions regarding what clinical trials are. Or if you have any questions that weren’t answered in this post, please add them to the comments section below.

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