Clinical trials are new territory for most patients. In this section, you will learn the following:
a) what it means to give informed consent to participate in a clinical trial;
b) when it might be right for you to do so;
c) the requirements, or eligibility criteria for clinical trials; and
d) 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. It demands that clinical investigators educate potential study subjects to ensure that a truly informed decision to participate in a clinical trial is voluntary and not coerced, and that patients have a good knowledge base and understand everything that is involved.
An informed consent is a document that explains every part of the clinical trial, but 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 in words that are geared toward non-medical readers, and it explains what the trial consists of in detail. It demands that a doctor assume responsibility for educating a patient about a trial, alternatives to doing that trial, and the potential risks of the drugs involved. It also requires that a patient must assume responsibility for asking questions and agreeing to participate in a trial based not on fear or intimidation, but on facts.
Are Clinical Trials Safe?
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.
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. Potential participation in a study should be discussed in depth with your physician and healthcare team. Before agreeing to participate, patients must learn about possible risks of the therapy being studied and what other options for treatment are available.
When Does "Eligibility Criteria" Mean?
In clinical trials, there are certain conditions and requirements that patients must meet in order to be deemed suitable for a research study. When all subjects meet the same eligibility criteria, it provides researchers with consistent data needed to answer the question 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, and 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?
Tests and procedures that are considered standard of care (e.g., routine blood tests, X-rays, myeloma-specific measurements) are usually covered by health insurance policies. However, study-related tests and procedures are paid for by the study sponsor. These may include additional bone marrow biopsies, more frequent skeletal surveys, magnetic resonance imaging (MRI), positron emission tomography (PET), computerized axial tomography (CAT or CT), pharmacogenomics, pharmacodynamics, and pharmacokinetics-related tests.