Planning for Prostate Cancer Research Expanding the Scientific Framework & Professional Judgement Estimates
Harold E. Varmus, M.D., Director	National Institutes of Health	Submitted June 1999

Section 5 of 13

PART II: FIVE YEAR PROFESSIONAL JUDGMENT ESTIMATES

National Institutes of Health: Total Professional Judgment Estimate

Planning for discovery is both laced with uncertainty. The NIH facilitates asking questions and creating tools and resources. We do not order specific study designs or specific products. Thus, our professional judgment report largely describes vehicles that the larger scientific, clinical, and industrial enterprise would fill with specific ideas, clinical trials, experiments, and technologies. Exactly which of these will flesh out the NIH Plan will be determined by the final availability of resources, by what projects come forward, what projects are ready to go, and what projects are deemed best through independent, competitive peer-review processes. In summary, this report identifies potential prostate cancer research opportunities worth about $420 million in 2003.

Five Year Professional Judgment Estimate

(in thousands)	1998 (baseline)	1999 Estimate	2000 Estimate	2001 Estimate	2002 Estimate	2003 Estimate	98-03 Change
NCI	$86,907	$141,500	$211,000	$267,000	$307,500	$340,000	$253,093
NIDDK	16,223	26,100	31,300	37,900	46,200	56,900	40,677
NHGRI	4,343	4,769	5,893	6,326	6,803	7,327	2,984
NCRR	2,086	2,532	4,000	4,500	5,000	5,500	3,414
NIEHS	1,261	2,300	3,110	3,610	4,210	4,910	3,649
NIA	1,402	1,540	3,000	3,000	3,000	3,000	1,598
NlNR	625	690	800	900	1,000	1,100	475
NIMH	415	478	615	715	815	915	500
NIDCD	349	394	458	458	458	458	109
Total NIH	113,611	180,303	260,176	324,409	374,986	420,110	306,499

National Cancer Institute

For each area of the Plan, we state the needs, or goals, in terms of priority questions for which answers are needed. This is followed by a description of the strategies and plans by which we hope the questions will be answered and the goals met. While some of the initiatives described here are not specific to prostate cancer, they are so relevant to prostate cancer that we included them expecting that they will help us answer important prostate cancer questions. For each goal we have tried to be as explicit as possible. We have attempted to cost out carefully and accurately the type, number, and size of the projects and investments that we can reasonably predict that the current pipeline of research and development would demand and on which the current research capacity is capable of rapidly acting. In the following pages, we describe in depth four areas of research opportunities by which we have formulated this professional judgment budget: Clinical Science; Translational Science; Risk, Burdens, and Outcomes Science; and Basic Research and Discovery. The order of these sections relates to the time expected to elapse between the research and the potential effects on patients with, or at risk for, prostate cancer.

The near-term goals achievable through clinical science, such as clinical trials, are, in a sense, easier to plan, and are listed first. The mid-term goals of translational research and research on cancer burdens and outcomes follow. And, finally, we describe the more long-term investments in basic research. For each of these four areas, we expect progress to be made through individual and collaborative investigator-initiated research, as well as through more directed programs.


How NCI Plans for Discovery in Prostate Cancer

To capture the many new opportunities in all types of cancer research, the NCI has engaged, for several years, in an extensive process of planning and implementation. Our strategy covers the cycle of evaluating the state of the science, identifying opportunities, and reviewing the results of our efforts preparatory to launching a subsequent scientific effort. These steps are:

• Conduct Cancer Research Program Reviews: The NCI's Program Reviews were conducted to review and reform, when needed, the major infrastructures by which cancer research takes place in this country. Outside panels conducted the reviews and made recommendations that we have begun to implement. The Program Reviews covered: Cancer Centers, Clinical Trials, Drug Discovery and Development, Cancer Prevention, and Cancer Control. The charge to each of the review groups was to recommend whatever changes were needed to make sure that the best science was supported in the most effective and efficient ways, to most rapidly and most predictably reduce the burden of cancer. Each group's report can be found at http://deainfo.nci.nih.gov/advisory/bsaprgr.htm.
  
  
• Identify Extraordinary Opportunities: We established areas of extraordinary opportunity for new investment priorities. This has resulted in the initiation of dozens of new programs aimed at speeding progress in cancer research. Expanded investment in each of these Extraordinary Opportunities will help us overcome current limitations in the speed of progress against cancer, will impact all cancers, and can be articulated in terms of tangible plans with achievable objectives. The Extraordinary Opportunities are described in NCI's Bypass Budget document, The Nation's Investment in Cancer Research (http://wwwosp.nci.nih.gov/NCIWEB/planning.htm).
  
  
• Develop Disease-Specific Progress Reviews: These reviews assess our current portfolio of disease-specific research; identify gaps, barriers to progress and needs; and recommend what we need to make progress against the specific cancer site being reviewed. Progress Reviews in Breast and Prostate Cancer were completed in 1998.

The request by the Congress to outline the NIH professional judgment for prostate cancer research over the next five years comes at an opportune time. This past year, we received the Report of the Prostate Cancer Progress Review Group which is described in the first phase of this two part report to Congress, "Planning for Prostate Cancer Research: Expanding the Scientific Framework." This report made dozens of prioritized recommendations for a National Prostate Cancer Research program. We were gratified to see that many existing initiatives and process reforms already provide the vehicles for implementation of this report. Since the report was presented in September 1998, the NCI has been actively developing specific implementation plans. We have already begun to enact this National Prostate Cancer Research Program in three ways:

• Linking current and potential prostate cancer researchers to a "menu" of new research initiatives, resources and funding opportunities.
• Modifying existing NCI initiatives to tailor them to the prioritized needs of the prostate cancer research community.
• Creating new initiatives to fill in gaps in identified, high priority areas. Examples include a mechanism to rapidly fund new clinical trials in prostate cancer and a new, national, prostate cancer tissue resource.

Achieving these goals will require the active participation of the full prostate cancer research community and adequate resources. To ensure the former, we have engaged the prostate cancer and urology research communities in an outreach and communication campaign to make researchers aware of the full range of new opportunities in prostate cancer research. We have created a special page on the NCI web site calling attention to new opportunities in prostate cancer research (http://www.nci.nih.gov/prostate.html), and we are advertising this site at meetings and in medical and scientific journals.


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