Why Clinical Trials?

At some point in the care continuum, cancer clinical trials can be a treatment option for many patients. Clinical research in multiple myeloma has become a robust field with the National Cancer Institute (NCI) website cancer.gov listing more than 1,000 clinical trials. Patients should discuss with their treating doctors if participating in a clinical trial is an option fit for them.

What Are the Goals of Clinical Trials?

A clinical trial is a medical research study with people who volunteer to test scientific approaches to a new treatment or a new combination therapy. Each clinical trial is designed to find better ways to do the following: 

• prevent cancer 
• detect cancer 
• diagnose cancer 
• treat cancer 
• answer scientific questions 

When Are Clinical Trials Undertaken?

Clinical trials are undertaken only after laboratory studies  

• demonstrate the potential of a new drug, treatment, or procedure to work better than existing methods 
• outline the potential safety of the trial  

Why Are Clinical Trials Conducted? 

Clinical trials are conducted to improve patient care. These trials are helpful to 

1. determine if a new drug or treatment is more effective than existing treatments 
2. evaluate if the new drug or treatment has fewer or less harmful side effects than existing treatments 
3. accomplish both factors above 

When Should You Participate in a Clinical Trial? 

The U.S. Food and Drug Administration (FDA) has not yet approved potential new therapies for myeloma. Clinical trials can offer these new therapies. In clinical trials, researchers do not know if the new method will be better than standard therapy for patients who are being treated now. Yet, researchers do know that some clinical trials will result in better treatments for patients in the future.  

Taking part in a clinical trial is voluntary. Not all clinical trials are right for every patient. The IMF advises you to discuss clinical trial options in depth with your physician and healthcare team. Before agreeing to participate, learn about the possible risks of the therapy being studied. Also, consider what other options for treatment are available. 

What Criteria Must Be Met for a Patient to be Eligible for a Clinical Trial?  

Patients must meet certain conditions and requirements to be deemed suitable for clinical trials. When all study subjects meet the same eligibility criteria, it provides researchers with consistent data needed to answer the question of the study.  

Eligibility requirements are based on the type of clinical trial. Examples of eligibility may include:  

• age 
• performance status (See A Clinical Trials Glossary) 
• type and stage of cancer 
• certain medical tests 
• laboratory results 
• other illnesses 
• past treatments received 

The eligibility criteria for each clinical trial have two sections: inclusion criteria and exclusion criteria. Inclusion criteria determine who may participate in the clinical trial. Exclusion criteria are conditions that determine if a patient may not be able to participate in a study. Both the inclusion and exclusion criteria are a vital part of the research plan to get credible and consistent results.  

What Is Informed Consent?  

Informed consent is the process that requires a doctor to give a patient enough information about a procedure, strategy, or clinical trial. This information includes the following issues: 

• risk of the trial 
• benefits of the trial 
• alternatives to the trial 
• potential costs of the trial  

Patients must receive this information to decide whether to consent to the proposed treatment. 

Medical Progress and Patient Safety  

Clinical trials are used to further test new medications and therapies on human subjects. Clinical trials are performed using protocols that adhere to accepted standards of patient safety, informed consent, and data interpretation. Strict regulation of clinical trials helps to ensure that the balance between medical progress and patient safety is carefully maintained.  

What's Next?