What You Need to Know About Clinical Trials

Patient Expert

People who are diagnosed with lung cancer may want to consider participating in clinical trials. These studies involve volunteering for a research study that tests detection methods, diagnosis methods, analysis methods, new drugs, alternative therapies or new devices to determine if these treatments work and are safe for use. These studies help researchers advance the pool of knowledge and available resources that eventually may benefit people who are diagnosed with lung cancer in the future. Ultimately, the goal is to eventually prevent lung cancer.

People with lung cancer who want to volunteer in a clinical trial should do so only after exploring the full picture of what their involvement may mean for them.

How studies are organized
Although the researchers have analyzed previous studies and conducted lab research, they do not know what the results of a clinical trial will ultimately be when the study starts. Researchers are strictly bound by laws, requirements and procedures that protect the rights and the health of study participants. For instance, all research must be approved prior to the start of a clinical trial. Furthermore if a new investigational drug is being studied, researchers must file an application with the Federal Drug Administration (FDA) before treating human study subjects with the new drug.

Clinical trials are often multi-year commitments that are designed to advance knowledge about the area being studied. Researchers often conduct clinical studies in phases that have specific goals:

  • Phase 0 – Exploration to determine if and how a new drug may work
  • Phase 1 – Exploration into whether the new treatment is safe
  • Phase 2 – Exploration into whether the new treatment works
  • Phase 3 – Exploration into whether the new treatment is better than what’s currently available in the marketplace

Benefits of participating in a study
Participants should be aware that any treatment administered during the study is considered experimental and may not ultimately help their condition. With that said, some studies do offer participants the possibility of getting “cutting-edge” treatments that may make a difference for their condition.

Study participants also create a medical legacy that will help others who are diagnosed with lung cancer in the future. Therefore, it’s important to weigh the benefits and risks of participating in a clinical trial and determine whether participation in a trial fits an individual’s values, preferences and priorities.

Cost of participating in a study
Potential participants need to talk to their insurance companies about whether the costs of participating in a clinical trial will be covered by insurance. Many insurance companies have been reluctant to cover these costs since the treatments are not “proven” to be effective.  Insurers may only cover costs that would have been part of a normal treatment plan if the participant wasn’t taking part in the study.

In many studies, the study’s sponsor will cover a participant's new treatment, follow-up assessments and travel costs. The sponsor may be a government agency, a drug company, a biotechnology company or another type of agency.

Identifying clinical trials
Several resources are available that can provide information about clinical trials that are recruiting new participants. These resources include:

Primary Sources for This Sharepost:
American Cancer Society. (2014). Clinical Trials: What You Need to Know.