Delimiter Image

Understanding Clinical Trials

Clinical Trial Information

Understanding Clinical Trials

A clinical trial is a research study that is intended to help the medical community find new safe and effective ways to prevent, detect or treat diseases, such as cancer. Clinical trials are complex, and many investigational agents fail to show benefit in humans.

Medical researchers conduct clinical trials over many years, and in several phases to assess whether an experimental medicine is safe and effective for people to use.

PRECLINICAL

PHASE I

PHASE II

PHASE III

Mid-to-large sized studies of people with the disease to help determine if an experimental medicine is safe and effective for the intended patients. These studies also monitor for side effects or adverse reactions. Phase 3 studies may also compare the new treatment with the current standard treatment.

If an investigational therapy makes it through these phases, the sponsor of the investigation drug may seek the Food and Drug Administration’s (FDA) approval. The FDA will evaluate and determine if the experimental medicine should be approved and made available for doctors to prescribe to people diagnosed with the disease.

Reasons to join a clinical trial

There are many reasons to participate in a clinical trial:

  • Care provided in an expert research setting with close supervision by the doctors involved with the clinical trial
  • Access to the latest treatments being developed when there are no existing treatments that work well for a disease, particularly in rare disease
  • Advance the science and understanding of a disease to help others who may have it in the future

Potential risks of joining a clinical trial

 As all treatments (approved or experimental) may cause side effects, there are potential risks to consider before joining a clinical trial. Considerations may include:

  • The investigational treatment may not work as well as existing treatments
  • There is the potential for known and unknown side effects of unproven treatments
  • Increased visits to the doctor and extra tests, which can be burdensome and time consuming
  • The subject medicine has not been proven safe or effective for the purpose being studied

If you’ve joined a clinical trial, it’s important to report to the study team any symptoms or side effects you may experience while participating in a clinical trial. This information will help advance the researchers’ understanding of how the experimental medicine works, and what potential side effects other patients may experience.

If you are interested in joining a clinical trial, talk to your Care Team about whether that might be right for you.

Finding a Clinical Trial

There are resources available online for people with soft tissue sarcoma who are interested in joining a clinical trial. Finding a trial that might be a match for your specific situation can be overwhelming, so turn to your Care Team for support with reviewing your options.

Additional information on available clinical trials include:

Sarcoma Foundation of America (SFA) Clinical Trial Matching Service: A list of active sarcoma clinical trials with a brief description of the trial and patient enrollment status.

Sarcoma Alliance for Research Through Collaboration (SARC) Clinical Trials: A service provided in collaboration with EmergingMed to help patients quickly search for clinical trial options that match their specific diagnosis and treatment history.

Cancer Support Community: Offers a Clinical Trials Matching Service with phone and web-based pre-screening, referral and education services for individuals searching for appropriate clinical trials.

ClinicalTrials.gov: This government-run clinical trial database allows users to search terms like ‘epithelioid sarcoma’ or ‘soft tissue sarcoma’ to narrow results.

Feeling overwhelmed about your options for clinical trials? Seek support from your Care Team.

References: Click to Expand
  1. Clinical Trials. National Heart, Lung, and Blood Institute (NHLBI). Accessed Jan 15, 2019. Available at: https://www.nhlbi.nih.gov/health-topics/clinical-trials
  2. Heneghan, C., et al. Why Clinical Trial Outcomes Fail to Translate into Benefits for Patients. BMC. 2017; 18(122). Available at: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1870-2#Abs1
  3. The Basics of Clinical Trials. American Cancer Society. Accessed March 26, 2019. Available at: https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/clinical-trial-basics.html
  4. Phases of Clinical Trials. National Cancer Institute. Accessed March 26, 2019. Available at: https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/phases
  5. The Drug Development Process, Step 4: FDA Drug Review. The U.S. Food and Drug Administration (FDA). Accessed March 20, 2019. Available at https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405570.htm
  6. Making the Decision About Clinical Trials. American Cancer Society. Accessed March 26, 2019.Available at: https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/who-does-clinical-trials.html