Clinical Trials: Overview

      A clinical trial is a research study involving volunteers that looks into using new drugs or therapies — and can give patients early access to incredible new treatment options. SurvivorNet consulted top oncologists from around the U.S. to put together this guide on the importance of clinical trials, when patients should consider enrolling, and what to expect when enrolled.

      Where to Find Trials

      If you are interested in taking part in a clinical trial, the first thing to do is speak to your doctor about the possibility of a trial. Blindly Googling trials may not be the best approach, however, the government does have a running clinical trial database you can make use of.

      Your doctor should also be able to recommend any trials that might be a good fit for you.

      Understanding ‘Inclusion’ Criteria

      However, just because you are willing to take part in a clinical trial does not necessarily mean you will be able to join. These trials have specific criteria that patients need to meet in order to take part. At the end of the day, even though these trials can have incredible results and provide you with access to cutting-edge therapies, these are controlled experiments.

      For each trial, there will be certain inclusion and exclusion criteria.

      Sometimes, patients may be excluded from certain trials if their cancer has spread to their brain. If the metastases are not under control, the patient may be unable to participate because researchers are concerned that they will not be able to complete the whole study.

      Your ‘Right to Try’ Cancer Drugs

      There are options for people who may not be eligible for the clinical trials they wish to participate in, but still want to try the therapies. A few years ago, the U.S. passed something called “Right to Try” legislation. This gives terminally ill people access to highly experimental drugs that are in “phase one” of the clinical trial process.

      Your doctor may also request access to a single patient IND (investigational new drug) on your behalf, which can also give access to treatments that the FDA has not yet approved.

      Risks vs. Benefits

      While clinical trials can provide people living with cancer with access to groundbreaking new treatment options, and even potential cures in certain situations, there are risks associated with enrolling in trials as well.

      Risks include:

      • Researchers may be unaware of potential side effects of new treatments
      • The experimental treatments may not work
      • It may be inconvenient to continue check-ins
      • You could be part of the trial that is not initially given the new drug

      Dr. Dana Chase explains why it’s important for patients to have open and candid discussion with their doctors about the potential to enroll in clinical trials.

      Understanding Informed Consent

      The informed consent process for a clinical trial will usually involve the research team presenting you with both standard consent forms as well as any other relevant information you may need about the treatments to know whether you wish to begin a clinical trial.

      Before you enroll in a trial, you must be given the opportunity to read the consent documents fully and to ask any questions you may have.

      The documents will likely contain the following:

      • The purpose of the research
      • Any risks and benefits expected from the research
      • Information about procedures that may cause discomfort (like frequent blood tests)
      • Any alternative procedures the patient might consider instead
      • How the patient’s information will be kept private
      • How long the study is expected to take
      • A form confirming you are participating in research voluntarily
      • Whether any compensation or additional medical care is available if some sort of injury occurs
      • The patient’s rights (like the right to stop research in the middle of the trial)
      • Contact information for any patient questions
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