Washington
Round-Up
March 13, 1998
New Initiative in Clinical Research
Training and Career Development
On Friday, March
6, 1998, the National Institutes of Health (NIH) announced
three new types of career
development awards that will be directed to increase the participation
of clinical researchers in "medical research and enriching
the pipeline of people properly trained to do clinical research."
The newly created awards, which
NIH expects to start funding in Fiscal Year 1998, will support
young investigators who have just completed specialty training
and mid-career investigators. Institutional curriculum awards
will be established to teach the essentials of clinical research
to young trainees and junior faculty.
The following are the three awards
that will be offered. More details will be available in the
April 6th NIH Guide Notice.
The Mentored Patient-Oriented Research
Career Development Award (K23) was developed for investigators
just after specialty training-a critical juncture for developing
investigators. The award is focused on providing both didactic
training and mentored research experience to individuals, such
as medical doctors, for up to five years. Also eligible are
dentists, osteopaths, chiropractors, optometrists and others
certified to perform clinical duties. Investigators will commit
at least 75 percent of their time to the program. NIH estimates
that there will be 80 new K23s each year.
The Mid-Career Investigator in Patient-Oriented
Research Award (K24), was developed for mid-career clinical
scientists. Because of the demands placed on their time, the
opportunity for these investigators to have dedicated research
time and to be mentors to other investigators is scarce. Such
opportunities are vital to the future of clinical research
and medicine. To address these concerns, the K24 relieves investigators
from patient care and administrative responsibilities. Investigators
will receive support for up to five years, with the possibility
of a one-time renewal. NIH estimates that 50 to 80 awards will
be made each year.
The Institutional Curriculum Award
(K30) is designed for institutions with a substantial clinical
research portfolio and a critical mass of individuals in clinical
research training and career development. It is meant to stimulate
the inclusion of high quality, comprehensive courses in the
fundamentals of clinical research-for example, biostatistics,
epidemiology, study designs, bioethics, legal and regulatory
issues-as part of the career development of clinical investigators.
The maximum award for a program, which may not exceed five
years, will be $200,000 per year. NIH expects to fund about
20 such programs in the first year.
Specter Inquires About Clinical
Research at NIH
In a March 3rd letter to Dr. Harold
Varmus, Director of the NIH, Senator Arlen Specter (R-PA),
Chairman of the Senate Appropriations Subcommittee on Labor,
Health and Human Services, and Education, inquired on the status
of clinical research at the NIH. Specter wants to know the
status of current clinical research projects recommended by
the Institutes of Medicine and enacted by the FY 1995 Senate
Appropriations Committee Report. The areas that Specter inquired
about include:
"Efforts to
increase NIH funding of all phases of clinical research through
physician scientists and clinical trials.
Efforts related to
the training of physician scientists to avert the declining
numbers of physician scientists entering careers in clinical
research.
Efforts to ensure
that a thorough review of clinical research grants are undertaken
by the NIH. Specter believes that under the current system,
physician scientists must compete against basic science applications
when applying for NIH funding.
Efforts to expand
the number of clinical trials as well as the number of patients
participating in clinical trials."
Dr. Varmus testifies before the
Senate Appropriations Subcommittee on Labor, Health and Human
Services, and Education on Thursday, April 2, 1998.
Gorden and Lenfant Present FY
1999 Testimony
On Wednesday, March 11, 1998, Dr.
Phillip Gorden, Director of the Institute of Diabetes and Digestive
and Kidney Disease (NIDDK), testified before the House Appropriations
Subcommittee on Labor, Health and Human Services and Education,
on the FY 1999 budget request for the NIDDK. Attached is a
copy of Dr. Gorden's written testimony.
During the question and answer section
of the hearing, both Chairman John Porter (R-IL) and Congressman
John Stokes (D-OH) asked kidney disease related questions.
Chairman Porter asked Dr. Gorden if he believed enough funding
is allocated at the NIDDK for kidney disease research. Dr.
Gorden responded by explaining the leading causes of kidney
disease and he said that the NIDDK was working hard toward
finding a cure. Congressman Stokes asked Dr. Gorden to report
on the progress made in the last year on the AASK clinical
trial that is looking into hypertension among African Americans.
Dr. Gorden responded by stating that progress was being made,
but did not go into specifics.
On Thursday, March 12, 1998, Dr.
Claude Lenfant, Director of the National Heart, Lung, and Blood
Institute (NHLBI), testified before the House Appropriations
Subcommittee on Labor, Health and Human Services and Education,
on the FY 1999 budget request for the NHLBI. Attached is a
copy of Dr. Lenfant's written testimony.
Medicare Advisory Panel Holds
First Meeting
The National Bipartisan Commission
on the Future of Medicare held its first meeting on Friday,
March 6, 1998. The meeting included statements from most of
the panel members as to what they hope the Commission will
accomplish, as well as an explanation of the rules and procedures
for the Commission's tenure.
The 17-member panel
was created to "identify problems that threaten the financial integrity
of the 32 year old federal entitlement program and suggest
solutions." Included in their evaluation will be a review
of the current Medicare graduate medical education (GME) program.
The panel's findings are due by March 1, 1999.
Attached, please find a copy of
the statements from Senator John Breaux (D-LA), Chairman, and
Congressman Bill Thomas (R-CA), Administrative Chairman, of
the Commission.
IoM Committee to Hold Forum
on NIH Research Priority Setting
On April 3, 1998,
a committee created by the Institute of Medicine will be holding
a forum that will
allow the public to comment on the current NIH research priority-setting
process. The committee is a result of the FY 1998 NIH appropriations
bill that contained language directing the Department of Health
and Human Services to "contract with the Institute of
Medicine to conduct a comprehensive study of the policies and
process used by the National Institutes of Health to determine
funding allocations for biomedical research."
The committee is also accepting
written comments via the web at http://www2.nas.edu/hsp/214e.html.
Democrats to Offer Managed Care
Legislation Next Week
Senators Tom Daschle (D-SD) and
Ted Kennedy (D-MA) intend to introduce managed care legislation
for the Democrats during the week of March 16-20. Please find
a copy of the Draft Managed Care Consumer Protection Bill Outline
attached to this update.
