Clinical trials are new territory for most patients. In this section, you will learn the following:

  • What it means to give informed consent to participate in a clinical trial
  • When it might be right for you to do so
  • The requirements, or eligibility criteria for clinical trials 
  • How insurance companies approach coverage issues with such trials.

What Is Informed Consent?

Informed consent is a vital part of the research process and is mandated by law for every participant in every research study. Informed consent

  • requires clinical investigators educate potential study subjects to ensure that they make a truly informed decision to participate in a clinical trial
  • Patients must be voluntary and not coerced to participate.
  • Patients have a good knowledge base and understand everything involved.

Informed consent is a document that explains every part of the clinical trial. It is also the discussion between a patient, physician, and other members of the healthcare team that must take place before the document is signed. The consent form is written for non-medical readers. It explains what the trial consists of in detail. 

Informed consent requires doctors assume responsibility for 

  • educating a patient about a trial
  • alternatives to doing that trial
  • the potential risks of the drugs involves

Also, if a patient takes part in a clinical trial, informed consent implies that the patient  

  • has assumed responsibility for asking questions 
  • has received all the facts of the trial
  • has not been coerced by fear or intimidation

Are Clinical Trials Safe?

Clinical trials further test new medications and therapies on human subjects. The protocols of these trials adhere to  

  • accepted standards of patient safety
  • informed consent
  • data interpretation

Strict regulation of clinical trials ensures a balance between medical progress and patient safety.
 

When Is the Right Time To Participate in Clinical Trials?

Taking part in a clinical trial is voluntary. Not all trials are right for every patient. Your physician and healthcare team should discuss with you the implications of your participation in a clinical trial. Before agreeing to take part, patients must learn about 

  • possible risks of the therapies being studied
  • other available options for treatment

When Does "Eligibility Criteria" Mean?

In clinical trials, patients must meet certain conditions and requirements to be considered suitable for a research study. When all subjects meet the same eligibility criteria, researchers can work with consistent data needed to answer the questions of the research study.
Eligibility requirements are based on the type of research study or clinical trial. Examples of eligibility may include:

  • age
  • performance status 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, which determines who may participate in the trial
  • exclusion criteria, or conditions that determine if a patient may not be able to participate

When Does Insurance Cover Clinical Trials?

Health insurance policies usually cover standard tests and procedures. Some examples include routine blood tests, X-rays, and myeloma-specific measurements.
Yet, the study sponsor pays for study-related tests and procedures. These study-related tests and procedures may include:

  • more bone marrow biopsies
  • more frequent skeletal surveys
  • magnetic resonance imaging (MRI)
  • positron emission tomography (PET), computerized axial tomography (CAT or CT)
  • pharmacogenomics, pharmacodynamics
  • pharmacokinetics-related tests


The International Myeloma Foundation medical and editorial content team

Comprised of leading medical researchers, hematologist, oncologists, oncology-certified nurses, medical editors, and medical journalists, our team has extensive knowledge of the multiple myeloma treatment and care landscape. Additionally, Dr. Brian G.M. Durie reviews and approves all medical content on this website.

Last Medical Review: August 1, 2019

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