The Clinical Research Debate

By Edward D. Miller, M.D.

All last year, a small group of deans and other key people from medical schools around the country trekked to Washington, D.C., every few weeks to sit on a committee for the Association of American Medical Colleges. I was one of them. The AAMC wanted a plan to deal with threats facing clinical research at America’s academic medical centers.

A dull-sounding task you might think. Let me assure you it turned out to be anything but. For almost a century, clinical research as served as a hallmark of our nation’s academic health centers. In our medical schools and hospitals, tomorrow’s physicians gained their first exposures to clinical inquiry, and in our laboratories, physician-researchers tested new therapies to combat disease. Funded mainly by pharmaceutical firms, these clinical trials offered hope to people with conditions that once signaled certain death.

Today, vast new understandings of the genetics of illness have led medicine to the threshold of an era that could improve health care as never before. But the key to this giant step forward will be a clinical research enterprise that can assess immense numbers of treatments quickly and efficiently. At this crucial moment, our academic medical centers no longer possess the people or the dollars to support such a research enterprise. Here are the problems:

• Most clinical trials aren’t conducted at academic medical centers any more. Anxious to get the job done quickly and cheaply and to reap the profits for marketable new drugs, pharmaceutical firms are outsourcing trials to community hospitals, private-practice physicians and groups outside the United States.
  
  
• Too few academic curricula today introduce medical students, residents and fellows to clinical research and convey the excitement in this kind of investigation.
  
  
• Oversight and funding of studies using human subjects is in disarray. The death of a research subject at one university and government citations of poor management at several others have alerted us to the need for  stringent guidelines for clinical studies. At the same time, such guidelines cannot become so intrusive that they prove stultifying to researchers.
  
  
• Insurers, as a rule, offer no reimbursement to patients who act as subjects in trials of new treatments, often their only hope.
  
  
• The whole question of how much it costs to do clinical trials and where this funding should come from hasn’t been addressed.

Such thorny issues took time  to tackle. We spent months surveying universities about their programs and interviewing experts. As the last millennium came to a close, we put together a compendium of the steps that will lead to a robust national clinical research effort that will keep pace with the leaps forward now occurring in basic science. Here are the key elements of what must happen:

1. Clinical studies must take place at academic medical centers. New approaches to treatment must be tested on multitudes of carefully selected patients in trials conducted by investigators who can interpret sophisticated data and determine whether a treatment should be released to market. Such analytical skills can be found today almost exclusively among physicians practicing at teaching hospitals and medical schools.
   
   
2. Medical schools and teaching hospitals must institute formal programs in clinical research for physicians at every step of their training to convey the excitement of the field and ensure that it thrives as a branch of medicine.
   
   
3. Every academic medical center must maintain a central oversight group for clinical research. These “internal review boards” (IRBs) must put into place guidelines to assure patient safety,  accurate collection of data and clear documentation of results. At Hopkins, we’re already making certain that clinical investigators are in compliance with new federal regulations that protect human subjects. We’ve audited every one of our gene therapy trials, and just went live with a mandatory Web-based course for researchers. The first lesson reviews human-subjects protocols.
   
   
4. The federal government must commit ongoing support, in addition to current funding from the National Institutes of Health, to the national clinical research effort to help pay the huge indirect costs of carrying out trials. This funding should supplement money flowing into clinical research from two other sources: industry and academic medical centers.
   
   
5. Managed care organizations and other insurers must recognize that new discoveries about treatments improve health care. At a minimum, they must reimburse patients who take part in clinical trials for the medical tests and examinations they undergo that would be part of any accepted treatment.

Following these steps can’t help but provide better health for us all. But to achieve that will require a commitment from the federal government, the pharmaceutical industry and academic medical centers themselves to join together to shore up clinical research. When that happens, the nation will find itself with a smoother road to medicine’s future.