Concerns About Clinical Trials

In the United States and many other countries, a clinical trial is the primary means of testing a new medical product’s safety and effectiveness. This method, however, isn’t without risks. Learn about some of the concerns raised by medical professionals, government agencies and pharmaceutical companies regarding clinical trials.

Clinical Trials: Risks for Volunteers

For most new drugs and other medical products, the clinical trial is the first time they are used in humans. In the early phases of a clinical trial, researchers aim to ensure the new product is safe to use humans, and determine at what dose (if the product is a drug or biologic) the product becomes toxic.

The number of volunteers is kept low during these early phases of a clinical trial to minimize the number of people placed at risk for health problems. For the volunteers that do participate, the risks may be considerable.

Clinical Trials Issues: Cost and Time

Clinical trials are expensive. Costs can include lab tests, medical equipment, hospital stays, salaries and compensation for volunteers. The high cost of developing a new drug or medical device translates into higher costs for the patients that may eventually be prescribed this new treatment or drug.

Clinical trials can also be time-consuming. Some trials go on for years before approval is granted to sell the product. In the meantime, sick patients may be waiting for the new treatment to become available.

The U.S. Food and Drug Administration (FDA) and similar agencies around the world have been trying in recent years to standardize the regulations governing clinical trials. The aim is to reduce costs and reduce the time necessary to conduct clinical trials.

Clinical Trials: Data Integrity

A clinical trial is often sponsored by the medical company that hopes to profit from the potential new product. These companies want their product to perform well, so they can eventually get approval to sell it. This situation creates an incentive for the company to potentially report the trial data in a biased manner, possibly hiding the product’s flaws or making the product appear to be more effective.

The FDA’s Division of Scientific Investigations works to combat the potential for data falsification by auditing data records and investigating facilities where clinical trials are conducted.

Resources

The Center for Information and Study on Clinical Research Participation. (n.d.). Research participant concerns. Retrieved December 12, 2010, from http://www.ciscrp.org/professional/concerns.html

ClinicalTrials. (2007). Understanding clinical trials. Retrieved December 12, 2010, from http://clinicaltrials.gov/ct2/info/understand

National Cancer Institute. (2010). Cancer clinical trials. Retrieved December 12, 2010, from http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials

U.S. Food and Drug Administration. (2010). About DSI. Retrieved December 12, 2010, from http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091393.htm

U.S. Food and Drug Administration. (2010). The FDA’s review process: Ensuring drugs are safe and effective. Retrieved December 12, 2010, from http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm