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What Are Clinical Trials?

January 24th, 2011

Duke University is no stranger to controversy. The latest problem involves cancer patients who participated in clinical trials based on flawed research by a discredited associate professor named Anil Potti.

(For more details about this story, watch our YouTube video here: Duke Clinical Trials Investigation.)

A lot of people find the topic of clinical trials confusing, so we’ve put together this brief explanation.

About Clinical Trials

When you go to the doctor to get medication, surgery, or other treatment for an illness, medical science has already demonstrated that the treatments or procedures work because they have passed extensive, pre-designed research “tests” known as clinical trials.

To explain how this works, imagine that there’s a brand-new, fictional medication called MEMOR-ALL, which was developed to help improve memory. Before MEMOR-ALL can be given to patients, it has to pass research tests to show that MEMOR-ALL:

  1. Is safe, without serious side effects.
  2. Does what it was designed to do. Put simply, does it really work? (In this example, does MEMOR-ALL actually improve memory?)
  3. Works better than current standard treatments.

These questions are answered by a series studies collectively known as “clinical trials.” Each individual question is called a “Phase.” All Phase I clinical trials address the question of safety…Phase II trials address the question of whether the medication works…and Phase III trials address the question of whether the new treatment works better than old treatments.

People volunteer to participate in clinical trials for a number of really good reasons. Clinical trials can give people access to new research treatment before they become widely available… allow them to get treatment at a leading health care facility… and make a contribution to medical science. Of course, there are some major risks, depending on which Phase is being tested. For example, patients in Phase I run the risk of side effects, and patients in Phase II or Phase III may be placed in a research group that does not received the new treatment (receiving, instead, either an ineffective placebo or a different treatment, depending on the type of testing being conducted).

Before signing on for clinical trials, people are supposed to be fully informed about the potential risks and benefits of the research–a process called “informed consent.” This is an important part of research protocol to prevent people from being used as unwitting guinea pigs in a scientist’s risky research.

If you participated in these clinical trials (or underwent testing for them) and have questions about what your legal options might be, contact the compassionate lawyers of HensonFuerst. We’re available 24/7 to anyone in the United States at 1-800-4LAW-MED.

If you have questions, HensonFuerst has answers.