Choosing Clinical Trials

A clinical trial is just one of many treatment options at Medical Oncology Care Associates. Investigational studies may offer exciting new treatment possibilities, and it can be exhilarating to be part of making cancer history. For others with advanced cancer, clinical trials may offer new hope when standard treatments have failed.

Before participating in a clinical trial, discuss it with your doctor or cancer specialist. Make sure to get all the details of the intended benefits and possible side effects before signing any consent forms.

Here are some issues to consider before enrolling in a clinical trials:

Eligibility – Clinical trial investigators follow strict criteria to recruit study volunteers. Recruitment forms list “inclusion and exclusion criteria” things like diseases type, treatments status, medical history, age range, gender, ethnicity and other factors necessary to join the trial. Forms may also list what investigators aren’t looking for, known as “exclusion criteria.”

Benefits – Although clinical trials offer no guarantees, scientists have a strong belief that study drug or treatment will provide benefits equal to or better than standard care methods. If that is the case, study volunteers will be the first to receive this new modality, and will continue to receive medical checkups to monitor their progress.

Risks – The clinical trial process is not risk-free. Study investigators have anticipated many of the side effects, but not all can be known ahead of time. If a new treatment exhibits potentially dangerous side effects, the trial is immediately discontinued and participants receive follow-up care to ensure they were not harmed. Remember, most standard cancer treatments do have side effects, which include nausea, hair loss and compromised immune systems.

Duration – Clinical trials can last anywhere from a few weeks to several years. Some require frequent clinic or hospital visits, which can interfere with your normal routine; others only need monthly or quarterly monitoring. Some studies, particularly Phase Three, are conducted at several locations, but if you don’t live near a trial site, you may have to consider long travel issues or temporary relocation to participate.

Cost – It is essential to determine what your out -of-pocket expenses will be in a clinical trial before enrolling You may be responsible for some or all of the costs involved, including blood work, x-rays, and other procedures. Sometimes, a biotechnology or pharmaceutical company or other research grant will sponsor a clinical trial and pay some, but usually not all expenses.

Insurance – Call your health insurance carrier or managed care provider to see if they cover clinical trials. Insurance companies may deny coverage if the treatment is considered experimental, but they might pay if the study treatment is similar to something the patient would receive outside a clinical trial.

Source: NIH