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      2 The Value of Clinical Research

       Michael B. Wallace and Peter D. Siersema

      2.1 Introduction

      In this review, we will cover major topics relevant to the performance and communication of clinical research, including key issues such as the value to clinical care, keys to conducting research, and how to build teams of successful researchers within institutions and between institutions. We will provide a basic overview on how to design clinical trials, generate research ideas, write grants, and conduct day-to-day clinical research. We will provide valuable information on how to present at national and international meetings and write and publish manuscripts. Finally, we will cover issues such as ethics and the future of scientific publications.

      Clinical research provides value through guiding physicians and other caregivers on how to choose the optimal method of diagnosing and treating diseases. It is fundamentally different from basic research, which focuses on mechanisms of diseases as well as normal and abnormal biological processes. Clinical research particularly focuses on the patient. In our daily practice, we struggle through decisions in virtually all patients including, which diagnostic tests to perform, what the optimal treatments are, and how to deal with the costs and adverse effects of our diagnostic and treatment approaches. It is widely acknowledged that there are major gaps in our knowledge. High-value clinical research should include several key elements including:

      • Selecting clinically relevant interventions for comparison to current standards of care.

      • Inclusion of relevant and diverse populations.

      • Collection of health-related outcomes important to patients, physicians, and payers.

      All clinical trials should be performed in a rigorous scientific manner that adheres to several key principles to provide accurate and reliable information.¹ Studies performed in a highly selected group of patients, who are fundamentally different from the patient we are currently caring for, do not provide reliable guidance. The value of clinical trials is only as great as the extent to which those results are communicated and made available to patients, colleagues, and providers. The process of scientific publication has long been the mechanism by which we communicate these results, although many other options are increasingly available; such as communication at scientific conferences, internet, and social-media based methods of data sharing.

      2.2 Keys to Success

      Clinical research is both tremendously rewarding and challenging. Over many years of conducting research we have defined four key elements to success:

      • A tough skin.

      • A team approach.

      • Attention to detail and a questioning approach.

      • Having long-term as well as short-term goals.

      2.2.1 A Tough Skin

      Even the most successful clinical investigators face many hurdles while conducting and publishing clinical research. Most competitive medical journals have acceptance rates of well under 20%. Large federal grants are even more competitive with funding rates now less than 10%. Thus, even excellent research proposals and papers may be rejected for funding and publication. To ultimately succeed, clinical investigators must be willing to accept the short-term failures and persist in conducting and publishing the research they believe in.

      2.2.2 Building Teams

      Building teams enables each member of the team to bring unique talents and ideas to a research project. Many of the best research projects occur at the boundary zones between different areas of expertise. A specific example of this is our research on the role of endoscopic ultrasound in lung cancer.^2,3 Both the field of endoscopic ultrasound and the field of lung cancer were represented by very different groups of physicians; however, working together identified unique contributions of each team. Beyond physicians, a successful team should include senior mentors, junior investigators, statisticians, experts in clinical trial design, study coordinators, and editorial assistants.

      Fellows play one of the most important roles in the team. For the fellow, the goals are to perform the research and to learn the process. The only way to do this, is to practice. Most academic medical centers include research activities as a part of their core curriculum. In addition to clinical fellows, who spend part of their time doing research, many programs offer dedicated research fellowships in clinical investigation. These programs often include dedicated training in research methodologies and advanced degrees such as a Master or Doctoral degree. Such didactic training has been shown to increase the likelihood of long-term research success.⁴

      Research