CLINICAL RESEARCH HANDBOOK, THE

Through clinical research, field changing ideas are formulated, tested, and ultimately translated into clinical practice with the goal of improving healthcare for generations to come.

From a practical perspective, there is a need for medical students both in the United States, and internationally, to be exposed to clinical research in their medical education. In the United States, many students are encouraged to perform research in medical school for the overall advancement of the field, and also to become competitive for the medical residency match process. The latter point has become even more important over the past two years as Step 1 has recently become pass/fail, and thus many students are turning to research to become competitive candidates in their field of interest.

However, often in the clinical environment, academic mentors are often busy and, in some medical schools, difficult to find. Therefore, students in these situations need a written resource that describes how to perform research for junior medical professionals. Internationally, some medical students may have difficulty finding mentors in guiding them to perform effective clinical research. Therefore, in: The Clinical Research Handbook, the authors attempt to provide a concise and effective reading that allows individuals to gain introductory knowledge in performing clinical research. We completely describe the process of research by describing how to formulate ideas, test these ideas, and submit these ideas as publishable manuscripts to journals.

Specifically, we cover many key concepts such as:

Where possible, we take all opportunities to explain these subjects in non-technical and easy to understand terms, and each chapter is designed to be read as a unique individual reading in an effort to save time for the reader. Since this is primarily aimed at individuals that are junior in their career, we aim to make this reading as low of a cost as possible. Using our book, medical students will be able to go from formulating ideas to accepted publication by using all of the information provided here.

Contents:

• Preface
• Getting Started:
  • Selecting Meaningful Research Projects for Real-World Impact
  • Formulating Ideas
  • Institutional Review Boards
• Types of Manuscripts:
  • Case Reports and Case Series
  • Retrospective Studies
  • Prospective Studies
  • Performing Systematic Reviews and Meta-Analyses
• Sources of Data:
  • Institutional Datasets
  • National Cancer Database
  • National Surgical Quality Improvement Database
  • ClinicalTrials.gov
  • Manufacturer and User Facility Device Experience Database
  • MarketScan Database
  • Nationwide Readmissions Database
  • Global Burden of Disease Database
  • TriNetX Database
  • Centers for Medicare and Medicaid Services Part B National Summary Data File
• Data Analysis:
  • Bivariable and Multivariable Comparisons
  • Survival Analysis
  • Creating Predictive Calculators
  • Meta-Analysis
• Achieving the End Goal:
  • Basics of Writing a Manuscript
  • Selecting and Submitting to Journals
  • The Journal Review Process and Responding to Revisions
• Additional Topics:
  • Intellectual Property
  • Mastering Grant Writing for Research Success
  • Ending Thoughts
• Appendices:
  • Preferred Reporting Items for Systematic Review and Meta-Analyses
  • An Example of Manuscript Formatting
  • An Example of a Response to Reviewers Document
  • An Example of a United States Patent
  • An Example of a National Institute of Health Biosketch
  • An Example of a National Institutes of Health 'Other Support' Document
• Index

Readership: Advanced undergraduate and graduate students, researchers, and practitioners in the fields of clinical research, medical sciences, healthcare analytics, and biomedical research. It is suitable for courses in medical research, evidence-based medicine, biostatistics, and healthcare data analysis, with potential for adoption in medical schools, public health programs, and biomedical research training programs.

By (Author)

Aaron Cohen-Gadol