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Epidemiology:
doi: 10.1097/01.ede.0000249529.86885.5a
The Changing Face Of Epidemiology

“Big” Science and the Little Guy

Ness, Roberta B.

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From the Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, Magee-Women’s Research Institute, Pittsburgh, PA, and the University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA.

Editors’ note: This series addresses topics that affect epidemiologists across a range of specialties. Commentaries are first invited as talks at symposia organized by the Editors. This paper was originally presented at the 2006 Congress of Epidemiology in Seattle.

This study has been supported by P01 HD30367 from the National Institutes of Child Health and Disease and 5MO1 RR00056 from the National Institute of Research Resources.

Editors’ note: Related papers appear on pages 1, 13, and 18.

Correspondence: Roberta B. Ness, University of Pittsburgh, Graduate School of Public Health, Room A527 Crabtree Hall, 130 DeSoto Street, Pittsburgh, PA 15261. E-mail: repro@pitt.edu.

“Big” science is part of the current landscape of epidemiology and has been for some time. An article in a recent issue of the Epi Monitor entitled “Epidemiologists Meet in Historic French Setting to Discuss Pros and Cons of Very Large Cohort Studies or Biobanks,” reports on a conference involving the “single largest gathering of epidemiologists to date” on the topic.1 A key finding was that there are (ongoing or planned) many more big studies than most epidemiologists know. Examples include the creation of biobanks in Iceland, the United Kingdom, Estonia, and Japan. A nonexhaustive list of already initiated studies of at least 100,000 subjects includes the Cancer Prevention Study (CPS) II, Nurses Health Study, European Prospective Investigation into Cancer and Nutrition (EPIC), Danish Birth Cohort, Norweigan Mother and Child Cohort Study, and Women’s Health Initiative Observational Cohort.2 Why this growing list? Because “big” science can be highly informative. Indeed, in a considerable number of situations (such as clinical trials and cohorts studying rare outcomes, case–control studies of rare exposures, and gene–gene or gene–environment interactions), a “big”-science approach is mandatory to obtain precise estimates. Yet the glitter of large sample sizes and major investments is not all gold. “Big” science has a major disadvantage—assuming a zero sum investment in epidemiology, concentration of resources in a limited number of projects will necessarily redirect resources away from individual investigators.

Junior investigators constitute the future of our profession. For them, “big” science—whether young investigators join in or not—represents a potential threat to productivity and personal development. Thus, whether individually we embrace “big” science, oppose it, or simply keep our heads down and hope it will pass without doing us much personal harm, we must, for the good of the continuation of our profession, find best practices for dealing with it.

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Why Focus on Junior Investigators?

Why do we train anyone in our discipline? The answer, of course, is that young professionals continue, augment, shape, and even transform our science. They bring modern technical capabilities, innovative ideas, and an uncontaminated way of thinking about well-trodden epidemiologic problems. “Big”-science projects generating large and complex databases often (if not always) require novel approaches to be fully informative. For instance, pattern recognition, systems modeling, haplotype analysis, multilevel analysis, and other evolving analytic tools have been helpful in making sense of large and complex databases. Young investigators with recently acquired skills are often on the cutting edge of the application and development of emerging techniques. Thus, not only is it imperative that we nurture our generation to maintain the health of our discipline, but it is useful that we involve them in our most costly and intensive studies.

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What Does the Junior Investigator Get Out of Participation in “Big” Science?

Many consider “big” science to be run by “old boys’ clubs,” and it is a truism that the leaders in “big” science are typically well-established investigators. Nonetheless, young scientists can gain much from collaborating in consortia or large projects. The ultimate output of “big” science is often rich both in output and import. For instance, the Women’s Health Initiative, the most costly clinical trial ever funded in the United States, lists on its web site 157 publications to date.3 The best of such science produces not only many scientific papers, but also ancillary grants, allowing novel ideas to be tested within the richness of a large database. “Big” science potentially has big public health impact. The National Surgical Breast Adjuvant Project has brought us a series of clinical paradigm shifts, including breast conservation surgery for treatment of breast cancer, as well as tamoxifen, raloxifene, and taxanes, trastuzumab, and other agents for chemotherapy and chemoprevention of breast cancer. Thus, by hitching a ride on an expensive project, young investigators can enhance their productivity while increasing their impact.

Other advantages for junior investigators are several. First, they will likely interact with multidisciplinary teams that, when assembled to accomplish the biggest projects, are necessarily large and complex. This provides junior investigators with access to a broad range of scientific disciplines and a wide array of accessible knowledge. Financial streams may also be accessible primarily through “big” science collaborations or spinoffs. For example, the National Institutes of Health has a granting program, the R21, designed for high-risk, high-gain, ancillary studies; add-ons to existing large projects provide a perfect R21 platform. Finally, infrastructure support, in the form of laboratories, statistical support, and mentoring, may not be readily available at a home institution but may be found through a “big”-science collaboration. Overall, junior investigators may enjoy a concentration of resources within large collaborations that may be harder to find elsewhere.

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What Are the Downsides to the Junior Investigator?

Junior investigators are rarely principal investigators on large projects. They rarely receive credit for owning the central intellectual property, rarely take a front seat in decision-making, and rarely take a lead on publishing main results. Why is this? An investment in “big” science generally requires an abundance of prior, supporting research often conducted by the senior investigators who then put forth the central ideas and main proposals for a large research project. Even if the instigation for a “big”-science project comes from a less established scientist, there is often a more senior individual named as titular Principal Investigator to give experiential credence to the research team.

This situation, in which one or a group of senior investigators lays claim to the origin or ideas on which the big project is based, has a series of downstream effects. First, established investigators generally enjoy a premier position in decision-making. The direction and implementation of work is often made by an Executive Committee representing senior investigators. Second, these senior investigators commonly take the lead on key study outputs, including papers and continuation grants/studies. Third, and not surprisingly, attribution of credit for study findings is generally afforded to these same established scientists.

For junior investigators, these realities mean that, although they may put a great deal of work into projects, they can find themselves without the authority and power either to shape study direction or to advocate for their own interests. A concern is that as the study reaches the point of productivity, younger scientists become nth author on publications and minor coinvestigators on linked or supplementary grant proposals (if they have a spot at all). Take, for example, a clinical trial with 3 dozen sites, one of which is administered by a junior person. Site administration, with its attendant need for staff oversight, quality assurance, and complete data collection, may be a markedly time-consuming job. However, because the investigator is only one of dozens of site investigators, the payoff may be tenth authorship, corporate authorship, or only an uncited acknowledgment. Indeed, given the scope and necessary dispersion of responsibilities, how is it possible for all of a group of many investigators to receive high-profile credit?

Limited control and credit may make “big”-science participation for the junior investigator look like a poor investment. Traditionally, promotion and tenure decisions in academia, government, and industry hinge strongly on documentation of independent, important scientific contributions. For instance, in academia, independence is judged by principal investigatorships on federally funded grants with the National Institutes of Health R01 being the coin of the realm; it is also based on first or senior author publications in prestigious journals. In “big”-science collaborations, these options may not be immediately available to junior investigators.

Success within large groups, although aimed at accomplishing the best science, may require attributes that are dominantly political. That is, a junior investigator’s interpersonal skills may trump intellectual acumen in promoting self-interests. Self-confidence, articulateness, charm, and interconnectedness may be more important survival tools than excellence in scholarship. To the extent that the “idea’s the thing,” this may not best serve science. Moreover, junior scientists with creative ideas may be stymied if and when they lack the ability to self-promote.

Finally, and importantly, “big” science tends to concentrate big budgets in a small number of hands and institutions. Some consortia build on previously funded studies, so resource allocation becomes circular, ie, those previously funded are assured of future funding. Institutions with strong, established infrastructures are more likely to compete successfully for spots in large collaborations. Those with sizable programs in support of clinical trials or statistical genetics or laboratory genetics, or those who have accessible defined populations, are the ones most likely to be involved. Moreover, within institutions participating in large projects, internal resources may differentially flow toward groups collaborating in “big” science so as to successfully compete for the next round of initiatives.

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Model Solutions to Embrace the Little Guy in “Big” Science

Experience from ongoing large-scale collaborations has taught us something about how to support the next generation of investigators while reaping the benefits of “big” science.

A direct way to afford leadership opportunities to junior scientists in the context of “big” science is to include them in decision-making. Executive Committees can incorporate young collaborators while still maintaining nimbleness (ie, a limited number of members) by a system of rotation. Another way of enhancing input into decision-making is regular face-to-face meetings of all investigators and their invitees. These meetings, although they exist in almost all “big”-science undertakings, are usually designed to share information, rather than to shape design, but this need not be the case. Other mechanisms for input might include a computerized “suggestion box.” Finally, in the longer-term, legacy planning can strategically bring proven junior investigators into seats of power. Successors, promoted to lead the study from within, can be particularly appropriate mechanisms for studies with long follow up, multiple phases, or a progression of specific aims.

Recognition is afforded by published products (eg, papers and reports). The main products generally follow an a priori set of aims and hypotheses proposed by principal investigators and key coinvestigators. For junior investigators to have a role in these central study components requires a culture of altruism, ie, one that puts young people first, even when they may not have exercised the political muscle to get the study funded. Notably, that degree of altruism may go beyond the comfort zone of many senior investigators. Nonetheless, in every large collaboration, it is worthwhile to discuss options for assigning credit, weighing the interests of developing versus established investigators. One example wherein the steering committee of a large collaborative group made it an explicit aim to promote junior faculty is the InterLymph study. This study is being carried out by a consortium of investigators working on non-Hodgkin lymphoma epidemiologic studies. The first 2 of 3 publications (both in high-impact journals)4–6 from the group had junior investigators as first authors. Of the 8 planned projects in the consortium, 6 are led by junior investigators.

A more commonly exercised option that provides credit, albeit not for main papers, to junior investigators is for them to take a lead on ancillary papers, grants, and presentations. Within many cohorts, such projects have been the bread and butter of dissertations and postdoctoral projects for decades. Innovation is readily exercisable in the context of add-on projects and products. Thus, a new investigator with a clever yet risky idea may find secondary data to be a way to test the idea or to at least generate pilot data with which to begin to evaluate the idea.

A key component of promoting all investigators within the context of “big” science is establishing rules that fairly link credit to work. Publication guidelines should be established at the initiation of consortia and multisite projects. Credit can be made available in the form of authorship, grant coinvestigatorship, and site or component principal investigatorship as examples. One rule allocating credit, as linked with work, might be that number and order of authorship flow not only from seniority and interest, but from the degree to which the author contributed to the science.

Finally, spreading the wealth of the rich resources that “big” science generates can support goals both for science and for the profession of epidemiology. This means bringing in young scientists housed at institutions beyond those that are part of the collaboration. Mentorship need not be site-specific, and mentoring bright young investigators outside the institutions of senior investigators serves to broaden the base of the discipline.

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What Institutions Can Do

All of this discussion assumes that the rules of collaboration can be negotiated but that the rules of professional promotion are fixed. It need not be that way. With the institution of the Roadmap program, Elias Zerhouni and the National Institutes of Health have challenged institutions to work out new models that allow for large clinical collaborations. If institutions truly value participation in “big” science, how would they encourage faculty involvement? What would promotion and tenure rules look like? First, authorship order would be more egalitarian. It would no longer be the case that the only spots that really “mattered” were first, second, and last. Related to this, journals would allow for as many authors as were really involved in a meaningful way. To assess the meaningfulness of contributions, journals would uniformly request that each author specify the nature of their contribution(s). Moreover, promotion committees would use this information in their decisions. Second, sharing of credit for grants by multiple principal investigators will likely become the norm if pilot testing of a new National Institutes of Health rule allowing this is successful. Like current rules for authorship at many premier journals, the meaning of (ie, contributions made by) investigators will need to be described rather than fixed by title. Third, tenure-track timelines would be more flexible. Rather than short up-and-out periods, the time between appointment and tenure would be negotiable with regular (eg, 2–3 year) interval reviews so that both the institution and the individual understand whether timely progress is being made. A notable concern about lengthening the tenure timeline is that this might indenture individuals for a longer period. However, this argument underscores the general principle that institutions need to start weighing individual contributions to science rather than counting discrete products. All of these changes would require hard rules so that the meaning of promotion and tenure remain undiluted. At the same time, they would allow for flexibility in collaboration and participation that reflects the reality of large and complex scientific endeavors.

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CONCLUSION

“Big” science is not something that we can wish away, and large and complex projects have their place in benefiting science and public health. Epidemiologists must also nurture our most critical resource—our next generation. To move forward the interaction between “big” science and young investigators, we must assess and possibly change both the implementation of the collaborations themselves and the rules institutions use to judge investigator contributions. Interactions between “big” science and the junior investigator are not necessarily easy. However, they must be made viable. Dialogue around how to appropriately credit investigators in “big” science is a beginning. I urge all of us to think openly about creative solutions that will ultimately benefit our science and our scientists.

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ABOUT THE AUTHOR

ROBERTA B. NESS is Professor of Epidemiology, Medicine, and Obstetrics/Gynecology at the University of Pittsburgh where she is Chair, Department of Epidemiology. Dr. Ness was one of the first to propose the research paradigm now termed “gender-based biology.” Ongoing studies involve the epidemiology of reproductive cancers, adverse pregnancy outcomes, and pelvic inflammatory disease.

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REFERENCES

1. Bernier RH. Epidemiologists meet in historic French setting to discuss pros and cons of very large cohort studies or biobanks. “Thick” and “thin” study designs are contrasted. Epimonitor. 2006;37:1–12.

2. Langholz B, Rothman N, Wacholder S, et al. Cohort studies for characterizing measured genes. Monogr Natl Cancer Inst. 1999;26:39–42.

3. Women’s Health Initiative (WHI) web site. April 13, 2006. Available at: www.nhlbi.nih.gov/whi/. Accessed August 3, 2006.

4. Morton LM, Hartge P, Holford TR, et al. Cigarette smoking and risk of non-Hodgkin lymphoma: a pooled analysis from the International Lymphoma Epidemiology Consortium (InterLymph). Cancer Epidemiol Biomarkers Prev. 2005;14:925–933.

5. Morton LM, Zheng T, Holford TR, et al. Alcohol consumption and risk of non-Hodgkin lymphoma: a pooled analysis. Lancet Oncol. 2005;6:469–476.

6. Rothman N, Skibola CF, Wang SS, et al. Genetic variation in TNF and IL10 and risk of non-Hodgkin lymphoma: a report from the InterLymph Consortium. Lancet Oncol. 2006;7:27–38.

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© 2007 Lippincott Williams & Wilkins, Inc.

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