Kenneth A. Getz
|
From most all accounts in the popular press today, much appears to be wrong with the clinical research enterprise: professional
greed, human errors and tragic patient deaths, conflicts of interest, data disclosure failures, the apparent concealment of
information, and lax federal oversight.
Spending on patient recruitment promotion programs is high and rising at the same time that enrollment and retention rates
are worsening. Recruitment ads are being met more by fear and suspicion among prospective study volunteers than by curiosity
and interest. And according to numerous polls and surveys, public trust in the pharmaceutical industry, the National Institutes
of Health, and academic research centers has eroded. Physicians and other health care professionals, for the most part, are
not referring their patients to clinical trials.
How is this beleaguered enterprise to repair and reshape its broken image? In part by borrowing lessons from an analogous
health care sector: organ donation. Clearly there are many ways that these two sectors differ. But there are also numerous
similarities that bear a striking resemblance to the challenges that the clinical research enterprise now faces.
Image repair
CISCRP: On a Mission (www.ciscrp.org)
|
Two decades ago the organ donation movement suffered from poor public perception, low awareness, and low trust. Politicians
and activists were upset by a series of medical errors that resulted in patient injuries and deaths. Practicing clinicians
were having trouble finding organs and donors. And those that were available were being inequitably distributed in hospital
emergency rooms.
Organizations involved in clinical research, much like organ procurement organizations (OPOs), "Seek an audience with people
about the opportunity to do something that...contributes to the world around them," said Tom Mone, CEO of Los Angeles-based
One Legacy, the nation's largest OPO. "In both cases, people need to voluntarily take action and think doing so is worthwhile.
This was at the core of repairing the image of organ donation and had to be addressed on many levels and across many fronts,"
he said.
Since the mid-1980s, the organ donation enterprise has nearly quadrupled the level of volunteerism and public support. In
1984, a mere 6900 organs were donated nationally. In 2004, 26,000 organs were donated. Although this level is still well below
the nation's current need, it represents a substantial improvement over that seen 20 years ago. All stakeholders in the clinical
research enterprise can learn from the experiences of the organ donation sector.
To begin, both government and private sectors recognized the organ shortage as a national and collective problem. Working
collaboratively, they countered it on a national scale with public service announcements (PSAs) and local outreach/education
programs.
PSAs focused on building national pride in organ donation and in acknowledging the profound gift that donors give. New state
laws allowed people to designate themselves as informed and willing organ donors on their drivers' licenses. Nonprofit organizations
sprung up to teach hospitals how to communicate more effectively with families facing the challenging decision whether to
harvest the organs of loved ones on the brink of death.
Legislative lessons
Federal legislation was enacted. The National Organ Transplant Act of 1984 effectively created a registry where clinicians
could quickly check organ availability and wait times. It also declared organ donation an altruistic act by outlawing the
purchase and sale of human organs. This act was followed in 1991 by legislation that encouraged the use of advance directives
and durable powers of attorney for health care. In 1999 came the Donor Leave Act that gave federal employees paid time off
from work to be a living organ donor. More importantly, that same year the Medicare program mandated that hospitals refer
all potential donors to an OPO.
