3.Why Are Clinical Trials Important?

Clinical trials are a key research tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don’t know:

• Whether a new approach works well in people and is safe
• Which treatments or strategies work best for certain illnesses or groups of people

Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different combinations ofasthma treatments. The trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients.

The results from other clinical trials show what doesn’t work or may cause harm. For example, the NHLBI Women’s Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms.)

The study found that, surprisingly, the risk of stroke, blood clots, and even breast cancer increased in women who took HT. As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible.

Clinical trials, like the two described above, help improve and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments that work best.

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