Thursday, June 25, 2020

MGH: A Guide to Understanding Clinical Trials" Part 1

Although this article is not specific to ovarian cancer, "A Guide to Understanding Clinical Trials" is important info for all of us.

Published on the MassGeneral website, I am including the full text below. This is part 1.

When a new disease such as COVID-19 is discovered, it is up to doctors and scientists to investigate how the disease behaves so treatments can be developed and tested.
There are numerous clinical trials for COVID-19 therapeutics across the globe, and results from these trials (often uncontrolled and published in non-peer reviewed journals) are being released on a regular basis.
With all of the new information coming out so rapidly, it can be confusing to understand what these results mean. The Mass General Research Institute is providing a resource to explain how clinical trials work and share what makes for a strong clinical trial with clear and promising results.

What are clinical trials and why are they important?

Clinical trials are scientific studies designed to test the safety and usefulness of new medical interventions such as treatments, devices, preventative care, screening or diagnostic procedures, and more.
They are crucial to the advancement of strong science and patient care because, if well-designed, they can validate the performance of an intervention under controlled circumstances to ensure it is safe, effective and provides measurable benefits to patients.

How do they work?

Scientists typically conduct research on a disease or potential treatment for several years to lay a foundation for a clinical trial. During this time, they are gathering as much information as possible to learn about how a disease behaves, what it does to the body, which populations are at risk for it and what may be potential targets for treatment. Research can move into the next phase, called preclinical or translational research, once enough promising and validated reproducible data have been generated to justify further testing.
Preclinical trials are the first opportunity to see how a treatment may work in specific non-human models. In this stage, scientists must follow strict guidelines to test their interventions in vitro (in a petri dish or test tube) or in vivo (in a living organism such as an animal model) before moving on to human trials. If the findings are promising, investigators must fill out the necessary paperwork and get approval so the study can move onto a Phase I clinical trial.

What happens in the four phases of clinical trials?

According to the Federal Drug Administration (FDA), there are four phases of clinical trials that each inform decisions made in the next phase:
  • Focus: Establishing the safety and correct dosage of a treatment
  • Time frame: Typically lasts several months
  • Sample size: 20-100 participants who are either healthy or have the targeted condition
  • Bottom line: Designed to understand how the treatment and dosage are tolerated within the human body

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