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Abstract
In the wake of widespread medical cost-cutting, companies specializing in organizing and running large multicenter clinical trials are a growth industry.
Physicians now practice defensive medicine to avoid the threat of legal action and to keep from being ostracized by insurers. Increasingly, they are asked to see more patients in less time, consult their colleagues less, accept lower reimbursements, and spend time justifying to administrators the value of tests. Hospitals, where cost-cutting is the norm, are also suffering. Outpatient care is encouraged as insurers pay less for hospitalization. It is no wonder that many physicians are leaving medicine or are seeking alternative ways to use their training and experience with less hassle. The commercialization of clinical research, including the testing and evaluation of new drugs, is providing many clinicians with an attractive alternative career or supplementary source of income.
In the past decade or so, clinical-research
testing of new pharmaceuticals and biomedical devices has
become a $10-billion industry that continues to
grow rapidly. Ten or fifteen years ago, pharmaceutical
companies directly contracted with
physician-researchers to run studies designed to evaluate
new drugs for humans. The companies directed the academic-research physicians, whom they paid through grants. An important change occurred in this field when
decision-makers in the pharmaceutical industry realized that hiring independent outside groups to direct clinical research was more cost-effective than using in-house resources. A new for-profit (and lots of it) industry, totally devoted to conducting and running clinical drug trials, was born.
Companies specializing in organizing and running large multicenter clinical trials emerged as a result of this decision. These organizations assume responsibility for: recruiting physician-researcher principal investigators to lead the trials; monitoring the quality of the trials, following good clinical practice guidelines; and ensuring that the detailed paperwork involving data collection, budgeting, and sometimes statistical evaluation of results is properly completed. These companies are called contract research organizations (CROs). Many, such as Quintiles Transnational, Scirex Corporation, Parexel International, Pharmaceutical Research Associates, and Concepts in Pharmaceutical Research Inc., are multimillion-dollar firms. Other companies actually hire the clinical staff they need - physicians, nurses, and other personnel to conduct clinical trials themselves.
Community hospitals and physicians in
private practice are benefiting from this growing
multibillion-dollar industry. Indeed, clinical research,
financed by the pharmaceutical industry, can now be a major
source of supplemental income to many practicing
physicians, nurses, and health-care facilities. Physicians who
have turned to clinical research in a major way usually have
had previous interest in pharmaceutical drug trials, have
dedicated nurses and clinical coordinators who do much of
the work, and have the specialty expertise and requisite
patient population needed to conduct successful drug trials.
An efficiently run operation is one that can enroll the
requisite number of patients in a timely manner and provide lean, reproducible data that will stand up to U.S. Food and
Drug Administration (FDA) scrutiny.
Today, community hospitals are forming clinical-research centers and hiring appropriate support personnel. As a result, they are attracting millions of dollars in grant money for such operations. Not wanting to be left in the dust by these private practitioners, colleagues, academics, and their institutions are fighting back. New clinical-trial centers are forming in major medical centers such as the Johns Hopkins School of Medicine, Duke University Medical Center, Washington University Medical Center, and College of Physicians and Surgeons at Columbia University. They claim to be more efficient and cost-effective, capable of recruiting more patients, and able to offer the superior research experience of their medical staffs. Such programs, like many scientific disciplines, run on reputation. If you prove you can enroll patients in an efficient, timely, and cost-effective manner, sponsors will come back for more help and bring with them more funds.
These few instances of failure should be
expected in a relatively new and rapidly growing industry. I
am an optimist and believe that as the industry matures,
clinical-trial research will become a more efficient and
cost-effective process in which academic centers (for the
more difficult studies), community hospitals, individual
physicians, and some of the outsourcing companies will all
have important and profitable roles to play. I predict
continued and successful growth of this industry.
Where is all this leading? Pharmaceutical
sponsors hope it will lead to a more efficient clinical research
"machine," whereby potential new drug entities will prove
themselves more quickly and in a fashion less costly than
before. They look forward to getting faster results in the
form of data that supports (or disproves) the efficacy of new
drugs. This means faster approval by the FDA, which means
faster potential profits. Of course, just as many one-product
biotechnology companies vanished when their one product
proved not to be a marketable commodity, some of these
clinical research organizations will fall by the wayside. In
fact, some have already folded. A few were even forced out
of business after being exposed as frauds, most notoriously
for forging data and making up nonexistent patients.
Ismail A. Shalaby is chief executive officer of Nema Research, a clinical research-implementation organization in Baltimore, Maryland.
Andrzej Krauze is an illustrator, poster maker, cartoonist, and painter who illustrates regularly for HMS Beagle, The Guardian, The Sunday Telegraph, Bookseller, and New Statesman.
Endlinks
Society for Clinical Trials - an international professional organization that publishes the journal Controlled Clinical Trials.
MedWeb: Clinical Trials - an alphabetical list particularly useful for trials related to specific diseases. From the Emory University Health Sciences Center Library.
Applied Clinical Trials Online - the online version of the journal has selected articles, such as Unleashing the Electronic Tiger: How the Internet is Changing Clinical Trials; useful links, and conference listings.
CenterWatch - collects information on clinical trials, advertises ongoing clinical trials by disease category, and lists clinical research networks and organizations (which pay to be listed). This is a good source for patients, pharmaceutical sponsors, clinical-research organizations, and small research entities.
FDA Institutional Review Board Operations and Clinical Investigation Requirements - one place to start learning about clinical trial regulations.
Web sites mentioned in this column: