Cancer Clinical Trials – What You Should Know

To the general public, these words can be overwhelming.

Even to people in the healthcare industry or those helping a loved one cope with a serious illness, the words “clinical trials” can conjure up images of desperate medical experiments with little hope of success. In reality, this stigma is unwarranted. Medical advances and breakthroughs can and have resulted from clinical trials. Without them, we wouldn’t have many of the treatments we have today. 

In short, clinical trials are research studies that allow for new and promising therapies to emerge from the laboratory to the bedside, comparing new, investigational therapies against the standard, current therapies.  Trials occur in well-defined phases.

Phase I trials:  These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe.  A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

Phase II trials:  A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works.  Phase II studies usually focus on a particular type of cancer.

Phase III trials:  These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization).  Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide

Often patients seek out clinical trials after all other standard therapies have failed. To qualify, a patient must complete a physical exam, give a full medical history and, if eligible, sign a consent form before receiving the experimental drug. 

The rules and regulations vary from trial to trial and a person’s past treatment history can dictate whether they are eligible or ineligible. Additionally, many insurance carriers restrict access to clinical trials, often denying coverage for doctor visits, laboratory tests, or medications associated with trials. Out of pocket expenses can be astronomical and make trials an unaffordable choice for many.  

Recognizing a need for change, the medical community and certain state legislatures have been trying to secure better coverage for clinical trials. Just recently, Texas, Oregon, and New Mexico passed laws requiring an improved level of care for people involved with clinical trials.  Even the sickest patients have a powerful voice, Use yours to seek from your legislators better insurance coverage to help gain access to potentially life saving clinical trials. 

To learn more about clinical trials, the National Cancer Institute’s site at www.cancer.gov There is an entire section devoted to clinical trials, including public search engines.   

Submitted by Heather Matthews, Cancer Research Specialist at Patient Navigator, LLC