What are Clinical Research Trials?

For a new medication to be approved for general use, it needs to be studied rigorously at clinical research sites to ensure the drug's safety and efficacy in patients.  Clinical research trials use carefully designed scientific processes to test new medications or the combinations of existing medications with volunteer patients to ensure it is of significant benefit and minimal risk to people.  These trials are closely monitored by specialty physicians and trained clinical trials staff.

Are there benefits to volunteering?

Participating in a clinical trial is an important decision. As a volunteer in a clinical trial, you are participating in the development of new medications.  Other important reasons to consider volunteering are:

  • New treatment options

  • Assist in advancing medical science

  • No cost for medical care

  • No insurance necessary

  • Possible compensation 

 

 

 

How do I know if I qualify for a clinical trial?

Before participating in a research study, a participant must qualify for the trial.  Along with following the scientific process designed for a study, clinical trials also have regulatory guidelines for patient qualifications.  Certain criteria for patients must be met including things like age, gender, type of disease, and overall medical history.  Our kind and friendly staff will walk you through these criteria to ensure that you qualify and begin a clinical trial.

 

 

How do I know I'll be safe if I participate in a clinical trial?
Our highest priority is the safety of our patients as they participate through our clinical trials.  At no cost to you (or your insurance), we perform lab assessments, exams, procedures, tests, and medications by qualified physicians and staff to ensure your safety through each trial.  At each study visit (and at any time throughout your participation usually through phone calls and/or daily/weekly logs), you will have the opportunity to describe any side-effects and/or adverse events (ranging from mildly annoying to life-threatening) that are experienced to honestly assess any medication you are taking.  Our physicians who oversee the trials are board-certified and readily accessible for questions and in the event of any emergency. 

Ideally, medications studied within clinical trial are proven to be of significant benefit and minimal risk to people and they'll obtain FDA approval for public use.  However, everyone may not respond positively to the medication and/or treatment within each trial, which still contributes valuable information from the research.  The need for diversity of patients who represent our overall population are vital here to assess the different effects of medication within different sub-populations. If it is obvious that the trial/medication is not producing the hoped-for results, it will thankfully be rejected from FDA approval and more research will be done to find something better.  

Your name is never reported with the study data; names remain confidential and are never revealed to the public, sponsors, or governmental agencies. You may withdraw from a study at any time for any reason, and study doctors may also discontinue your participation if they ever feel a your safety is at risk.

What should I consider before participating in a clinical research study?

We always want you to understand the study and feel comfortable participating and will do our best to inform you about the following, but here are some questions to ask yourself, your physician, and the clinic that may help you decide if participating is right for you:

  • What are the qualifications of the physicians and staff?

  • How will the trial help others?

  • How much time will this research trial take and how many visits will I need to come in for?

  • What will be expected of me as a research participant?

  • What can I expect when I visit the research site?

  • What kind of treatment will I be given?  Will I receive a placebo?

  • Will this treatment interfere with my current medication?

  • What will happen if I get hurt or sick?

  • Will it cost me anything to participate?

  • Do I need medical insurance to participate?

  • How much will I earn for participating?

  • Who will provide medical care for me after the study?

  • If the treatment works, can I keep using it after the study is over?

  • Will I receive follow-up care after the study is over?

**I think it would be good to ensure that most of these questions are answered within the FAQs as well (or at least the "What can I expect when I visit the research site?" one).**

What is informed consent?

The purpose of informed consent is to give you all the details you need to make a decision about participating in a clinical trial. Informed consent is not a one-time event. It is an ongoing process throughout one's study participation. An informed consent document contains information such as the study's purpose, length, procedures & tests, risks, and potential benefits. The study is discussed with participants and the informed consent document will be reviewed. Participants are given as much time as they need to read through the document and the participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

 

Still have questions? Please visit our Contact Us page and mention which studies best meet your interests. If you have specific questions call us at (801) 657-3206.

 

We look forward to hearing from you!