Data on NCI role in development of new cancer drugs

[James Love <love@cptech.org>]

These are some data that the US National Cancer Institute (NCI)
submitted to a House of Representative Appropriations subcommittee in
1998.  NCI reported that it spent $403 million on clinical trial, that
NCI was involved in the development of 6 of 12 new cancer drugs, and
that two thirds of the cancer clinical trials identified on CancerNet
are NCI sponsored trials.

  Jamie  


http://www.nci.nih.gov/admin/fmb/1998qa.htm#clinicaltrialdod


FY 1998 Questions and Answers provided For The Record for the FY 1998
House Appropriations Subcommittee.  These responses, developed by NCI
program and OD staff, are to the questions submitted by Subcommittee
members following the NCI Director's testimony before the Subcommittee.
The dialogue among the Subcommittee members and Dr. Klausner during the
appropriation hearing is available in hard copy through the NCI
Financial Management Branch. 

---------------------------

NEW CANCER DRUGS 

Ms. Northup: You mentioned 12 new cancer drugs approved by the FDA for
use in cancer. Are these drugs a result of NCI research or research done
in the private sector? 

Dr. Klausner: The National Cancer Institute collaborated directly in the
clinical development of 6 of the twelve approved drugs in that we held
INDs (Investigational New Drug Applications) and sponsored cancer
clinical trials which contributed to the evaluation and determination of
efficacy of the agents. In one case, the pivotal study used as the basis
for approval was conducted by a NCI funded Cooperative Group, Southwest
Oncology Group. In two other cases, NCI was substantially involved in
preclinical development of the drug, for example, with topotecan, a
soluble active analog of camptothecin, NCI was critically involved in
initial preclinical work. In fact, discovery of topotecan occurred
through the NCI-funded National Cooperative Drug Discovery Group
Program. It was developed subsequently by the corporate partner in that
program (Smith, Kline, and Beecham). With gliadel, NCI was critically
involved in funding initial studies of gliadel through its National
Cooperative Drug Discovery Group
Program. 


-----------------------


Mr. Stokes: How many clinical trials are currently being funded and how
much of the budget is invested in clinical trials? 

Dr. Klausner: For this year the NCI is projecting to spend $403 million
to support therapeutic and prevention clinical trials. Within the
clinical trials site on the NCI's Web site (CancerNet) over 1,500 NCI
clinical trials are listed with a description of each trial.
Approximately, two-thirds are NCI sponsored. Besides studying new
anticancer drugs, clinical trials study new combinations of drugs
already used in cancer treatment, new ways of giving treatment, and how
changes in lifestyle can help cancer patients or prevent cancer from
occurring including studies of the psychological impact of the disease
and ways to improve the patient's comfort and quality of life --
including pain control. Other clinical trials compare the best known
standard therapy with a newer therapy to see if one produces more cures
and causes fewer side effects than the other. 


- 
James Love
Consumer Project on Technology
http://www.cptech.org
love@cptech.org
202.387.8030; fax 202.234.5176