The Clinical Research Debate
By Edward D. Miller, M.D.
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.
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
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
- 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:
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.
- 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.
- Every academic
medical center must maintain a central oversight group for clinical
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.
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
This funding should supplement money flowing into clinical research
from two other sources: industry and academic medical centers.
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.
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.