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1 Introduction Historically, most cancer research has been conducted through small independent projects initiated by individual investigators with relatively small research groups. Such research is driven by focused hypotheses addressing specific biological questions. There will always be a need for this traditional approach to research; in recent years, however, it has also become more feasible to undertake projects on a broader and larger scale, thereby developing extensive pools of data and research tools that can facilitate those more conventional efforts. Large- scale science projects, in which many investigators often work to- ward a common goal, have become quite common, and perhaps even the norm in some fields of scientific research, such as high-energy physics (Galison and Hevly, 1992; Heilbron and Kevles, 1988~. The large-scale approach has also been used for decades or even centuries to develop astronomical charts and geological and oceanic maps that can be used as tools for scientific inquiry (see Appendix). However, the concept is still relatively new in the biomedical sciences, including cancer research. This new paradigm of biomedical research has become possible in part through technological advances that allow for high-throughput data collection and analysis an approach referred to as "discovery science." Traditional biomedical research is conducted by small groups that test hypotheses and are interactive but not highly collaborative, whereas large- scale biology often involves large, highly collaborative groups that deal with the high-throughput collection and analysis of large bodies of data. The two approaches can be synergistic in the long term when large-scale 12

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INTRODUCTION 13 projects produce data that can be used to generate hypotheses, which can then be tested with smaller-scale experiments. The biggest and most visible large-scale research project conducted in biology to date is the Human Genome Project (HGP), aimed at mapping and sequencing the human genome. While not exclusive to the study of cancer, the products of this project can serve as research tools for the study of cancer, and thus will have a far-reaching influence on the pro- gress and direction of cancer research in the future. As a result, there is considerable interest in the field of cancer research in developing other similar projects with broad potential benefits. Projects of the scope and scale of the HOP are perhaps unlikely to be launched in the foreseeable future, but many projects that are larger or broader in scope than tradi- tional efforts are already under way. One such initiative in cancer re- search is the Cancer Genome Anatomy Project (CGAP) of the National Cancer Institute. The goal of this project is to develop gene expression profiles of normal, precancerous, and cancerous cells, which could then be used by many investigators to search for new methods of cancer detec- tion, diagnosis, and treatment. At the same time, this recent interest in large-scale biomedical science projects raises many questions regarding how such projects should be evaluated, funded, initiated, organized, managed, and staffed. Once it has been decided that a large-scale approach is appropriate for achieving a specific goal, a variety of issues such as staffing and scientific training; challenges in communication, data sharing, and decision making; and intellectual property issues (patenting, licensing, and trade secrets) must be considered in choosing the appropriate venue for the research. Diffi- culties can also arise because research within large-scale projects may be conducted by multiple institutions and is often multidisciplinary, thus requiring management of diverse complementary components. In addi- tion, such projects often require strategic planning with clearly defined endpoints and deliverables, they often entail technology development, and they generally have longer timeframes than conventional research. These characteristics may not mesh well with the traditional organization and operation of research institutions, especially with respect to funding mechanisms and peer review, ownership of intellectual property, scien- tific training, career advancement, and planning and management over- sight within academic institutions. Many decisions must be made before a large-scale project is launched, such as where the funding will come from and how it will be made avail- able to investigators; what projects and institutions will be funded; and how activities will be organized, managed, completed, and evaluated. ~ See .

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4 LARGE-SCALE BIOMEDICAL SCIENCE The National Institutes of Health (NIH), in contrast to some other fed- eral agencies, has not developed a standardized or institutionalized ap- proach for making decisions about large-scale science projects, which require a long-term funding commitment. For very large projects that involve multiple federal agencies, there is also a need to coordinate funding. Moreover, such projects often attract international coopera- tion, so mechanisms for addressing such cooperation need to be in place. Finally, because large-scale science is very expensive, there is always concern that it will reduce the pool of money available for smaller, tradi- tionally funded projects and thereby slow the progress of innovation. As noted above, however, there should ideally be a long-term synergy between large- and small-scale projects in biomedical science, with the former providing new research tools and resources for the advancement of the latter. A variety of models exist for carrying out large-scale biological re- search projects, and each has its strengths and advantages. As noted ear- lier, the Human Genome Project is the largest and most visible undertak- ing in biology to date. In the United States, public funding for the project came from both NIH and the U.S. Department of Energy (DOE), but only after considerable debate over the merit of the project, the best way to accomplish its goals, and how to fund it adequately without reducing support for other aspects of biomedical research. In the end, significant investment was also made by private industry. With the successful com- pletion of the draft sequence (Lander et al., 2001; Venter et al., 2001), the project is now being hailed as a remarkable example of what can be ac- complished through a large-scale science venture in biology. But is this the best or only way to take on future large-scale biomedical research? There are other strategies for funding and organizing such projects, some of which have never been used in biology but have worked well in other scientific fields. Because the concept of large-scale science is relatively new to the field of biomedical research, and there is increasing interest is using this re- search format to advance the study of cancer, the National Cancer Policy Board determined that it would be useful at this time to address some of the issues and questions outlined above. The purpose of the study docu- mented in this report, then, was to: Define the concept of large-scale biomedical science, with a par- ticular focus on its application to cancer research. Examine the current state of large-scale science in biomedical re- search (what is being done and how). Examine other potential models of large-scale biomedical research.

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INTRODUCTION 15 Examine the ways in which the field of biomedical research is adapting to the inclusion of large-scale projects. Identify obstacles to the implementation of large-scale projects in cancer research. Provide policy recommendations for improving the process for conducting large-scale projects in cancer research should they be under- taken in the future. This report is organized as follows. Chapter 2 develops a working definition of "large-scale biomedical research" within the framework of this report. It also provides brief ex- amples of the types of projects that may be amenable to the large-scale research approach, as well as a brief overview of the challenges and im- pediments involved in using this approach. Chapter 3 provides in-depth information about a wide variety of past and current large-scale research models or strategies undertaken by the Na- tional Cancer Institute (NCI) and other branches of NIH, as well as examples from outside of NIH, including both public and private endeavors. Chapter 4 presents an overview of the available funding sources and mechanisms for scientific research, with emphasis on how they are adapt- ing to the emergence of large-scale projects in the biomedical sciences. Chapter 5 reviews the role of project management, oversight, and assessment in large-scale research endeavors. Chapter 6 provides a general overview of trends in the training and career development of biomedical scientists, and includes a discussion of how large-scale projects may influence or be affected by these trends.

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16 LARGE-SCALE BIOMEDICAL SCIENCE Chapter 7 examines the role of intellectual property in biomedical research, with particular emphasis on the availability of large-scale data and research tools. Chapter 8 summarizes the key findings of the study and presents the committee's recommendations.