Clinical Trials of New Medicines

Each year, bio/pharmaceutical research companies sponsor thousands of clinical trials of new medicines to generate comprehensive data needed for FDA product approval. Clinical trials take seven of the 10 to 15 years required to bring a new drug to market and involve thousands of patients and the generation of tens of thousands of pages of scientific documents. It is estimated that clinical testing accounts for 45 to 75% of the average $1.2 billion cost of developing a new medicine.

John J. Castellani

Over the years, these trials have proven to be vitally important to patients all over America, to states' economies, and to the advancement of science. Patients benefit from the fact that more than half of the trials since 1999 have been or are aimed at the six most debilitating chronic diseases: asthma, heart disease, stroke, cancer, diabetes, and mental illnesses.

It's also important that many trials being conducted today are still actively recruiting patients. For some chronic-disease sufferers, a clinical trial of a new medicine may provide a viable therapeutic option to consider and discuss with their healthcare providers.

Along with the benefits come some potential risks, which is why FDA regulates clinical tests. Trials also are reviewed and approved by an Institutional Review Board (IRB) to help make sure they are conducted ethically. IRBs are independent committees of physicians, community advocates, and others.

Clinical trials of new medicines represent a boost to the economy because the bio/pharmaceutical companies sponsoring the tests hire university medical centers, local hospitals, and other clinical research facilities to conduct them. Over the years, clinical trials have proven to be a good, steady source of revenue and business for local research institutions in states all over the nation.

Many of the medications clinically tested in states ranging from Oregon to Georgia and Illinois to West Virginia increasingly involve drugs resulting from cutting-edge science, including treatments derived from novel biological processes that feature living cells. In other words, many of the clinical trials of new medicines are helping to advance medical science and ultimately may help us to dramatically improve overall patient healthcare.

To demonstrate the positive impact that clinical development of new drugs has had all over the country, the Pharmaceutical Research and Manufacturers of America (PhRMA) is generating reports of trials conducted in 17 of the states since 1999. So far, the reports compiled from four states—West Virginia, Georgia, Oregon, and Illinois— show that during the past 13 years, about 11,000 clinical trials for new drugs have been conducted. More than 1100 of these trials are still active and recruiting patients.

In these states, clinical trials have proven to be an important economic boost. In West Virginia, for example, trials are underway at local research institutions all over the state, including facilities in Charleston, Huntington, Parkersburg, Wheeling, Morgantown, Elkins, and Beckley.

Clinical trials in the state have been conducted at institutions ranging from the medical schools at Marshall and West Virginia universities to regional hospitals, such as the Davis Memorial Hospital's Cancer Care Center in Elkins, the Raleigh Regional Cancer Center in Beckley, and the Charleston Area Medical Center.

In Oregon, trials are underway or have been conducted in Portland, Eugene, Bend, Coos Bay, Medford, Gresham, and other communities at institutions like the prestigious Oregon Health & Science University, the Willamette Valley Cancer Institute and Research Center, the St. Charles Medical Center, North Bend Medical Center, and the Clinical Research Institute of Southern Oregon.

In Georgia, clinical tests of new medicines are not just confined to in and around Atlanta, which has a strong bio/pharmaceutical and academic research infrastructure. Trials have also been underway at research facilities in Augusta, Macon, Columbus, Savannah, Athens, Gainesville, Albany, Lawrenceville, and other towns and cities.

In Illinois, nearly 4400 clinical trials of new medicines have been conducted since 1999, including 474 that are still recruiting patients. Although nearly 3000 of the trials have been conducted throughout the Chicago metropolitan area, the rest have been a boost to institutions in a number of downstate communities, including Springfield, Decatur, Champaign, Bloomington, and Peoria.

What these reports clearly show is that although bio/pharmaceutical companies often don't have a large "bricks-and-mortar" presence in the states, they nevertheless have a profound impact on patients and the economy through their sponsorship of thousands of clinical trials of new medicines.

John J. Castellani is president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA).