AUTHORIZING LEGISLATION

The legislative authority in Section 301 of the Public Health Service Act which provides for the award of grants for research, research training, and fellowships is included in the section of the justifications under the tab, "Preamble Paragraph".

The Public Health Service Act, Title IV, National Research Institutes, Part A, National Cancer Institute

"Sec. 401. The National Cancer Institute shall be a division in the National Institutes of Health."

"Sec. 402. In carrying out the purposes of section 301 with respect to cancer, the Surgeon General, through the National Cancer Institute and in cooperation with the National Cancer Advisory Council, shall—

(a) conduct, assist, and foster researches, investigations, experiments, and studies relating to the cause, prevention, and methods of diagnosis and treatment of cancer;

(c) Provide training and instruction in technical matters relating to the diagnosis and treatment of cancer;

(d) Provide fellowships in the Institute from funds appropriated or donated for such purpose;"

Research grant funds support activities in the cancer field within universities, hospitals, laboratories, research institutes, and other public or private nonprofit institutions. The purpose of these grants is to stimulate new investigations in fields where further exploration seems likely to be fruitful. The projects range from small, circumscribed activities to broad composite programs that integrate the research interests of many investigators in a variety of scientific disciplines. These grants make possible complex clinical research which would otherwise not be accomplished for many years.

Program plans in 1967

Grant-supported research will continue to place emphasis on studies of the biology and chemistry of growth, reproduction and differentiation of the normal malignant cell. It will include, also, extensive studies on various kinds of cancer in laboratory animals, along with individual studies of the cancer patient, and cancer in populations.

The Institute will support projects aimed at developing methods for identification of carcinogenic agents and hazards in man's total environment; atmosphere, water, food, drugs, tobacco, other natural products, occupation, radiation and infectious agents. Studies aimed at the viral etiology of malignant diseases will be emphasized. Grants will also support studies of various forms of therapy, especially chemotherapy and related pharmacologic studies of neoplastic diseases. Other studies will be devoted to radiobiology, especially the application of tools 78-317-67-pt. 5—19

and techniques from experimental radiobiology to radiation therapy so that cancer cells can be made more sensitive to radiation and normal cells less affected thereby increasing the effectiveness of radiation therapy. Since there is increasing evidence that cancer is essentially a cell disease, research efforts will be broadened to cover both extrinsic and intrinsic factors which might be involved in the cancerous change. The areas to receive expanded support will include cell biology, carcinogenesis and clinical research.

The programmed chemotherapy grant program will continue to provide support for clinical studies performed under extablished protocols to evaluate new agents for use as therapeutic materials for various types of malignancies.

Approximately 35 leukemia research support centers will be funded in 1967. These centers will continue to study new research therapy techniques involving new drugs and blood platelet transfusions to patients on both an outpatient and inpatient basis.

Cancer Institute grants now support 20 specialized research centers. These centers are now beginning to emphasize research on host defense mechanisms against tumors, the effect of cytotoxic drugs on immune responses, and attempts to define more precisely the mechanism of the action of anticancer agents. Furthermore, studies of radiation biology, physics, and nuclear medicine have been expanding. Much attention is being given to determinations of the optimum methods of employing chemotherapeutic drugs and other forms of therapy, and to the use of radiation as an adjuvant to surgery and chemotherapy. The funds for 1967 will allow increased support for existing activities plus the inauguration of several new installations. The specialized research centers item also includes planning grants which support costs incurred by institutions in the development of long-term plans for cancer research, training, and clinical service. In the 1967 budget, the centers were identified as "Categorical clinical research centers" ($7,790,000) and the planning grants were identified as "Specialized research centers" ($800,000).

The $600,000 available for life islands and related reverse isolation units such as laminar flow units will be sufficient to provide continued support to the six active grants. Life islands are enclosures in which patients are kept in essentially a germ free environment. Laminar flow units also isolate the patient through devices to control the flow of air. These are of interest because cancer drug dosages can be increased to higher levels in such environments without a corresponding increase in inside reactions.

Program plans in 1968

The $40.228.000 earmarked for support of non-competing continuations projects contains an increase of $2,580.000 over the 1967 level of support. representing 15 additional grants which will have a moral commitment during 1968.

The $17,173,000 requested for competing projects includes $10.278,000 for new regular research grants, which is an increase of $3,675,000 over the 1967 level of support for new grants. This increase permits the awarding of an additional 73 new awards in 1968.

The increase in new grants is partially offset by an estimated decrease in competing continuations of $1,993,000 and 53 grants. The net figure for competing grants is therefore an increase of 20 grants and $1.682,000. The major factor in these items is the cyclical pattern of the termination and subsequent renewal of continuations. The variance can be large from one year to another. Supplemental grants are expected to require some $188.000 more in 1968. The overall net increase in 1968 over 1967 for regular project grants is estimated at 35 grants and $4.450.000.

High priority will be given to support of research in the following areas: 1) studies aimed at determining the relationship between man's environment and his liability to malignant diesases, 2) research in the field of clinical pharmacology with particular emphasis on early diagnosis through specialized instrumentation, 3) research aimed at the development of better forms of treatment, 4) studies of viruses and their role in causing malignant disease, and 5) research relating to the development and application of tools and techniques for experimental radiobiology and radiation therapy.

The programmed chemotherapy grant program will remain at the same level in 1968, continuing to support the efforts of study groups operating under highly developed protocols.

The specialized research centers program will continue at the same dollar level in 1968. The increase from 36 to 40 grants is possible because some recently initiated grants which required high “start up" costs will need only operating funds in 1968.

The leukemia research support centers are expected to continue at the same level in 1968 as in 1967. Pending requirements will be mainly for 27 non-competing continuations, the result of grants awarded in 1966 and 1967. In 1968 anticipated increases in the number of applications will allow greater latitude in funding selectivity. Further evidence will be accumulated regarding platelet replacement therapy and its use as an effective tool in connection with the administration of control drugs.

In 1968 the life island program is expected to continue at the same level. The techniques of reverse isolation will continue to be studied in combination with chemotherapy and radiation techniques.

The purpose of the fellowships program is to increase the supply of investigators and teachers trained in basic and clinical sciences related to the field of cancer research. The program provides research training to individuals whose career development extends from the immediate post doctoral period through the advanced stages of scientific attainment. Post doctoral awards are made to qualified individuals with doctorate degrees but with little or no previous experience. Special fellowships are awarded to qualified individuals who have had at least three years post doctoral research or professional experiences.

This budget activity also supports two other types of awards made to institutions for the purpose of increasing the number of stable, full time career opportunities for scientists of high potential and capability in disciplines important to cancer research. The Research Career Development awards support investigators who require 5 to 10 years experience in order to improve their research skills and to develop a capability for independent investigation. Research career awards are made to established investigators of high quality for the duration of their research careers.

Program plans in 1967

In 1967 the number of awards in both the Postdoctoral and Special categories will remain fairly stable. As in the past, the Institute will select qualified individuals for specialized research training in such fields as immunology, biochemistry, cytogenetics, endocrinology, virology, and pathology. Continued emphasis will be given to encouraging interest and increasing training in the critical shortage areas of radiation therapy, surgery, hemotology, and clinical pharmocology and toxicology.

As a result of the NIH decision not to make additional Research Career awards, Research Career Development awards have and will continue to take on increased significance which will be reflected in modest but progressive increases in the number of awards made.

Program plans in 1968

With the requested increase of $156,000, the Institute plans to add a net of 8 special fellowships for candidates interested in the research aspects of radiation, therapy, surgery, hemotology, and clinical pharmacology and toxicology. The remainder will be applied to the moderately expanding development program and will be sufficient for funding a net increase of 13 Research Career Development awards. These increases are offset by decreases of 5 postdoctoral and 6 career awards.

Introduction

Graduate research training grants are made to institutions to help provide an adequate supply of competent research manpower, and to alleviate critical shortages of professional personnel in selected areas affecting the combination of research, teaching, and service. In addition to underwriting expenses for equipment, supplies, and training staff, these grants may provide stipends for individuals in training for a wide diversity of fields related to cancer research. Clinical cancer training grants assist qualified institutions in improving and expanding training in the prevention, diagnosis, treatment, rehabilitation, and public health aspects of cancer. The threefold purpose of these grants is to encourage institutions to: 1) upgrade the quality of cancer instruction offered to undergraduate and graduate medical, dental, and public health students and to interns, residents, clinical fellows, and practitioners; 2) broaden the scope and content of current cancer teaching; and, 3) undertake innovations in methods for teaching the clinical and public health aspects of comprehensive cancer management.

Program plans in 1967

Approximately 157 programs will be supported during the current year. Continued emphasis will be given to training in clinical pharmacology and chemotherapy, including the trial of new chemotherapeutic agents and new dosages, development of evaluative criteria for small effects and objective assay of the response of cancer cells to agents. Emphasis will be placed on establishing additional programs of clinical research training as well as conventional graduate programs in disciplines where cancer researchers are in short supply. Also, programming efforts will be strengthened in: 1) radiobiology and radiotherapy, 2) experimental surgery and physiology, 3) virology, and 4) nuclear medicine.

Program plans in 1968

The 1968 request includes the support of 8 new programs as compared with 17 in 1967 for a net decrease of 9 grants. Continuing programs being renewed in 1968 will increase by 17. This allows a net increase of 9 cancer clinical training grants offset by a decrease of 1 graduate grant. However, the entire $282,000 increase will be used to support the increased cost of established graduate programs. The renewal cost of the existing but relatively new cancer clinical training programs will be reduced to allow for the net increase of 9 grants.