Clinical Trials and Endocrine Disorders

The purpose of a clinical trial is to advance knowledge and improve quality of life. Clinical trials aim to make patient care better.

 

A clinical trial is a research study that follows a very specific guideline. The clinical trial guideline—the study plan or protocol—outlines the study’s purpose, defines who can participate and who cannot (called inclusion and exclusion criteria), risks and possible benefits, and other important information. 

 

Many current clinical trials study prevention, diagnosis, and treatment of different endocrine disorders. An endocrine disorder may affect one or more of your endocrine glands, which include: adrenal, ovaries (female), pancreas, parathyroid, thyroid, pituitary, or testes (male). You can learn more about the endocrine system and the specific gland in our Endocrine Overview.

In the United States, all clinical trials are approved, regulated, and monitored by an Institutional Review Board (IRB), which is under the control of the US Food and Drug Administration (FDA). An IRB is made up of independent doctors and other personnel to ensure the trial is ethical and participant rights are protected. The federal government, medical institutions, and private industry (e.g., pharmaceutical, biotech companies) commonly provide financial support for clinical trials.

 

Many years of laboratory testing often is required before human volunteers become involved in a study. Pre-trial lab research helps to increase participant safety and study efficacy, which is paramount. 

 

A new clinical trial usually enrolls less than 100 participants (called Phase I). Depending on Phase I results, the trial may be continued and involve greater numbers of participants. A Phase II trial may involve up to 300 participants, and Phase III may include up to 3,000. Each phase of the study is considered a separate clinical trial. A Phase IV clinical trial is also called a post-marketing study. A Phase IV study is established when the drug, device, or product is available for consumer use.

 

Before answering that question, talk with your treating doctor (such as your endocrinologist or primary care doctor), learn about the clinical trial, and carefully weigh all the possible benefits and risks. Although you may receive some medical care while participating in a clinical trial, your treating doctor should be involved to help avoid possible side effects (such as a drug interaction) and maintain your continuity of care.

 

Informed consent is one way to help you make a well-informed decision. The doctors, nurses, or other clinical trial medical staff will explain what the study is about, including:

 

You should never hesitate to ask questions before, during, or after a clinical trial because your health is involved. What should you ask? Listed below are general questions. You can add your specific questions to the list if you like.

 

While a clinical trial may provide you with early access to a treatment or novel prevention or diagnostic method, a successful outcome cannot be guaranteed. If you are considering participation in a clinical trial, involve your endocrinologist or treating doctor in your decision-making process.