About Clinical Trials

There has been a great deal of interest in the keratoconus community about clinical trials since corneal crosslinking trials were started in the US. The following will help you better understand clinical trials.

A clinical trial is a research study that tests how well new medical approaches work in people to answer scientific questions about a drug, a vaccine, a procedure or therapy or a new way of using a known treatment or compare a new treatment to a treatment that is already available.

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Clinical trials are the next step after research in the lab produces promising results. Carefully conducted clinical trials are the fastest and safest ways to find treatments that work in people and ways to improve health. Clinical trials can take place in a variety of locations, including hospitals, universities, doctors’ offices, or community health clinics.

Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people of populations in natural settings.

What Is A Protocol?
A protocol is a set of rules or action plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary – including details such as the criteria for patient participation, the schedule of tests, procedures, medications, and the length of the study. All clinical trials must be conducted according to strict scientific and ethical principles. Every clinical trial must have a protocol. In the United States, an independent committee or review board of physicians, statisticians and members of the community must approve and monitor the protocol. They make sure that the risks are small and are worth the potential benefits.

What Are Clinical Trial Phases?
Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.

  • Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

What Is Informed Consent?
Informed consent is the process of learning the key facts about the clinical trial before a person decides whether or not to participate. These facts include:

  • Why the research is being done
  • What the researchers want to accomplish
  • What will be done during the trial and for how long
  • What risks are involved in the trial
  • What benefits can be expected from the trial
  • What other treatments are available
  • That the participant has the right to leave the trial at any time
Who sponsors clinical trials?
Clinical trials are sponsored by government agencies, private organizations, and individual researchers who are seeking ways to improve the health of people living with a particular disease or condition. Sponsors can be:
  • Government agencies such as The National Institutes of Health (NIH), The Department of Defense (DOD), and The Department of Veteran’s Affairs (VA)
  • Pharmaceutical, biotechnology and medical devices companies
  • Individual researchers/physicians
  • Health care institutions such as academic medical centers and health maintenance organizations (HMOs)

Source:
National Institute of Health
Food and Drug Administration (FDA)

Use this resource from the National Keratoconus Foundation to better understand clinical trials.