Translational Surgery
- 1st Edition - March 22, 2023
- Editors: Jeffrey A. Bakal, Adam E.M. Eltorai, Paige C. Newell, Adena J. Osband
- Language: English
- Paperback ISBN:9 7 8 - 0 - 3 2 3 - 9 0 3 0 0 - 4
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 9 0 6 3 0 - 2
Translational Surgery covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully… Read more
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Request a sales quoteTranslational Surgery covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts including case-control studies, prospective cohort studies, randomized trials, and reliability studies. Investigators will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in surgical research, and know what is needed for collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps the translational research navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in surgery, allowing the reader to learn how to evaluate the quality of such studies. Thus, they will improve at measuring outcomes; making effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every surgeon or surgical researcher who has ever had a good clinical idea, but not the knowledge of how to test it.
- Focuses on translational research in Surgery, covering the principles of evidence-based medicine and applying those principles to the design of translational investigations
- Provides a practical, straightforward approach to help surgeons and researchers navigate challenging aspects of study design and implementation
- Details valuable discussions on the critical appraisal of published studies in Surgery, allowing the reader to effectively use all types of evidence for patient care
Surgeons, basic scientists interested in translating their research into clinical practice to your primary audience area alongside clinicians, Professional Associations
- Cover image
- Title page
- Table of Contents
- Handbook for Designing and Conducting Clinical and Translational Research
- Copyright
- List of contributors
- Preface
- Acknowledgment
- Part I. Introduction
- Chapter 1. Introduction
- Key points
- Get started
- Potential pitfalls
- Real-world examples
- Additional resources:
- Chapter 2. Translational research process
- Key points
- Why does it matter
- Background
- Current trends and scope
- Correlation and application
- Checkpoints for translational research trainee1
- Get started
- Potential pitfalls
- Example of translational research
- Additional resource
- Chapter 3. Scientific method
- Key points
- Why it matters?
- Observation
- Research
- Hypothesis
- Experiment
- Data collection
- Analysis
- Conclusions
- “Get started”
- Pitfalls to avoid
- Real-world examples
- Chapter 4. Basic Research
- Key points
- Introductory/Why it matters
- General approach to research
- Disciplines
- Common lab methods and techniques
- Getting started (action items)
- Pitfalls to avoid
- Real-world examples
- Resources
- Part II. Preclinical
- Chapter 5. Overview of preclinical research
- Key points
- Get started
- Potential pitfalls
- Chapter 6. What problem are you solving?
- Section 1: Introduction
- Section 2: Take away points
- Section 3: Pitfalls to avoid
- Chapter 7. Types of intervention
- Why it matters
- Introduction
- Understanding timing and types of interventions in clinical and translational research
- Getting started
- Chapter 8. Drug discovery and development
- Summary
- Introduction
- Target discovery and target validation
- Lead compound identification and optimization
- Preclinical development and clinical trials
- Current trends in drug discovery and future outlook
- Get started
- Potential pitfalls
- Examples of drug discovery and development
- Additional resources
- Chapter 9. Drug testing: translating a novel immunotherapeutic from bench to bedside
- Key points
- Introduction
- Getting started: design and optimization
- Real-world example: assessment of function
- Real-world example: toxicology and dosing
- Summary
- Resources
- Chapter 10. Device discovery and prototyping
- Key points
- Section 1: Introduction
- Section 2: Identifying an unmet need
- Section 3: Ideation, conceptualization, and prototyping
- Section 4: Budgetary considerations and how to fund
- “Get started” section: using dissolvable stent design as an example
- Potential pitfalls
- Real-world examples
- Resources
- Chapter 11. Medical device testing: a neurosurgical perspective
- Key points
- Background
- Overview (safety and efficacy)
- Medical device classification systems
- Investigational device exemption
- Budgetary considerations and funding resources
- List of some funding sources
- Avoiding pitfalls
- Resources
- Chapter 12. Diagnostic discovery
- Key points
- Introductory\Why it matters
- Beginning stages of diagnostic discovery
- Clinical usefulness
- Regulations for new diagnostic tests
- Pitfalls to avoid
- Get started
- Real world examples
- Additional resources
- Chapter 13. Diagnostic testing
- Introductory session/Why it matters
- Overview of diagnostic testing
- Get started:
- Pitfalls to avoid
- Real-world examples:
- Additional Resources:
- Chapter 14. FDA regulating power & guidelines: other product types
- What do they regulate and not regulate?
- Overlap between FDA and certain organizations?
- Roadmap of FDA approval process
- Postmarket safety monitoring
- Action steps
- Pitfalls
- Chapter 15. Procedural technique development
- Summary
- Introduction
- Preclinical development
- Stages of procedural development
- Get started
- Chapter 16. Behavioral Interventions
- Key points
- Section 1: Behavioral interventions
- Section 2: NIH stage model
- Get started
- Potential pitfalls to avoid
- Real-world examples
- Additional resources for the reader
- Part III. Clinical: fundamentals
- Chapter 17. Introduction to clinical research: What is it? Why is it needed?
- Section 17.1: Clinical research
- Section 17.2: The study question
- Section 17.3: The study design
- Section 17.4: Why are study designs important?
- Highlights and pitfalls
- Chapter 18. The question: types of research questions and how to develop them
- Key points
- The research question
- Development models
- Examples—the bad, good, and great
- Get started—action items
- Chapter 19. Study population: Who and why them?
- Key points
- Why it matters
- Why sample?
- Selection of the study population
- Bias in the sampling process
- Get started
- Potential pitfalls to avoid
- Chapter 20. Outcome measurements: What data are being collected and why?
- Key points
- “Why it matters?”
- Define terms
- Example 1
- Example 2
- Example 3
- “Get started”
- Potential pitfalls
- Corresponding links
- Defined terms
- Resources
- Chapter 21. Optimizing the question: balancing significance and feasibility—Will the findings affect change? Can that change be implemented in clinical practice?
- Part IV. Statistical principles
- Chapter 22. Basic statistical principles
- Key points
- Summary
- Section 1: An overview of statistics
- Section 2: Measures of variability and confidence intervals
- Section 3: Hypothesis testing and P values
- Section 4: Screening
- Section 5: Measures of disease frequency
- Chapter 23. Distributions
- Key points
- Introduction
- Normal distribution
- Mean of the sample
- Other distributions
- How to present the data
- Pitfalls
- Get started
- Real world examples
- Resources
- Chapter 24. Hypothesis and error types
- Key points
- Why it matters
- The null hypothesis and the alternative hypothesis
- Error types
- Multiple and posthoc hypotheses
- Potential pitfalls
- Get started
- Real-world examples
- Resources
- Chapter 25. Power
- Definition
- Underpowered studies—false negatives
- “Overpowered” studies—clinical versus statistical significance
- Chapter 26. Regression analysis
- Key points
- Why it matters?
- Introduction
- Linear regression
- Logistic regression
- Cox regression
- Model construction
- “Get started”
- Potential pitfalls to avoid
- Real world examples
- Resources
- Chapter 27. Continuous variable analyses: t-test, Mann–Whitney U, Wilcoxon sign rank
- Key points
- Introduction
- Real-world examples: paired variable analysis
- Real-world examples: unpaired variable analysis
- Get started
- Potential pitfalls
- Resources
- Chapter 28. Categorical Variable Analyses: Chi-square, Fisher Exact, and Mantel–Haenszel
- Key points
- Introduction
- Real-world example: Fisher Exact test
- Real-world example: chi-squared test
- Real-world example: Mantel–Haenszel test
- Pitfalls
- Get started
- Resources
- Chapter 29. Analysis of variance
- Key points
- Getting started
- Pitfalls
- Additional resources
- Chapter 30. Correlation
- Key points
- Why it matters
- Determining the strength of correlation
- Pearson's correlation coefficients
- Spearman's correlation coefficient
- Kendall's correlation coefficients
- Real-world examples
- Potential pitfalls
- Get started
- Chapter 31. Biases in research studies
- Defining bias
- Real-world examples
- Resources
- Chapter 32. Basic science statistics
- Key points
- Why does it matter?
- What is a variable?
- Type of variables based on output measurement
- Most common types of statistical tests used in basic sciences
- Most used descriptive statistics
- Examples of parametric tests
- Examples of nonparametric tests
- Get started
- Part V. Clinical: study types
- Chapter 33. Design principles: hierarchy of study types
- Key points
- Section 1: Asking the right question
- Section 2: Choosing the right study design
- Potential pitfalls/recommendations
- Real World Examples
- Resources
- Chapter 34. Case series: design, measures, and classic example
- Key points
- Basics of case series
- Get started: Writing case series
- Potential pitfalls
- Chapter 35. Case-control study—design, measures, and classic examples
- Key points
- Why it matters
- Content
- Benefits and limitations
- Designing your own study
- Examples
- Research team roles
- Funding
- Get started
- Pitfalls to avoid
- Resources
- Chapter 36. Cohort study: design, measures, and classic examples
- Key points
- Why it matters
- Content
- Benefits and limitations
- Designing your own study
- Examples
- Get started
- Pitfalls to avoid
- Chapter 37. Cross-sectional study: design, measures, classic examples
- Key points
- Definition
- Benefits and limitations
- Step-by-step design
- Section 1 Examples of cross-sectional studies
- Getting started
- Pitfalls to avoid
- Resources
- Online databases
- Chapter 38. Longitudinal study: design, measures, and classic example
- Section 1: Key points
- Introductory section\Why it matters
- Getting started
- Potential pitfalls to avoid
- Resources
- Chapter 39. Designing clinical trials of surgical interventions
- Key points
- Introductory section/Why it matters
- What are clinical trials?
- Advantages of a clinical trial study design
- Limitations of a clinical trial study design
- Get started
- Pitfalls to avoid
- Summary
- Real-world examples
- Chapter 40. Meta-analysis
- Keywords
- Key points
- Why it matters?
- Study design
- In practice
- Get started
- Potential pitfalls to avoid
- Chapter 41. Cost-effectiveness research
- Key points
- Why it matters
- Benefits and limitations
- Step by step design
- Definition of study type
- Costs
- Effectiveness and quality measures
- Time is money
- Decision analytic modeling
- ICER
- Accounting for uncertainty using sensitivity analysis
- Conclusion
- Define research team
- Budget considerations/how to fund
- Getting started
- Potential pitfalls to avoid
- Real-world examples
- Resources
- Chapter 42. Diagnostic test evaluation: design, measures, and classic example
- Key points
- Why does this matter?
- Introduction to evaluation of diagnostic tests
- Designing research to evaluate a new diagnostic test
- Four phases of evaluating a new diagnostic test
- Potential pitfalls
- Examples of assessing diagnostic tests in the literature
- Conclusion
- Resources
- Chapter 43. Reliability study: design, measures, and classic example
- Key points
- What is a reliability study?
- What is the difference between reliability and validity?
- Test–retest reliability
- Internal consistency
- Interrater reliability
- How do we account for chance?
- Note about pathological reliability
- Potential pitfalls
- Chapter 44. Database research
- Key points
- Why it matters
- Definition of study type
- Benefits and limitations
- Step-by-step design
- Define research team
- Budget considerations/how to fund
- Getting started
- Potential pitfalls to avoid
- Real-world examples
- Resources
- Chapter 45. Surveys and questionnaires: design, measures, and classic examples
- Key points
- Introduction
- Survey development
- Response rate
- Data analysis and reporting
- Data analysis and reporting
- Funding and budgetary considerations
- Get started
- How to avoid pitfalls
- Chapter 46. Qualitative methods and mixed methods
- Key points
- Why it matters?
- Qualitative methods: benefits and limitations
- Qualitative data collection strategies
- Data analysis and presentation
- Qualitative approaches for health services research
- Mixed methods designs for qualitative methods integration
- Getting started: designing a qualitative study
- Potential pitfalls to avoid
- Additional reading and resources
- Part VI. Clinical trials
- Chapter 47. Randomized control: design, measures, and classic examples
- Key points
- Introduction
- Designing the study
- Limitations
- Standard research team
- Budgetary considerations
- Funding
- Pitfalls
- Get started
- Resources
- Chapter 48. Nonrandomized control: design, measures, classic example
- Key points
- Introductory/Why it Matters
- Definition
- Benefits and limitations
- Step-by-step design
- Examples of nonrandomized control studies
- Getting started
- Pitfalls to avoid
- Resources
- Chapter 49. Historical controls
- Types of historical controls
- Overcoming bias and improving accuracy in historical control studies
- Chapter 50. Cross-over: design, measures, classic example
- Key points
- Definition
- Benefits
- Limitations
- Step-by-step design
- Examples of cross-over studies
- Getting started
- Potential pitfalls to avoid
- Additional resources
- Chapter 51. Withdrawal studies: design, measures, and classic examples
- Key points
- Withdrawal studies
- Design and measures
- Classic examples
- Get started—action items
- Chapter 52. Factorial design: design, measures, and classic examples
- Key points
- Introduction
- Design
- Analysis
- Benefits and limitations of factorial design
- Classic examples
- Creating your own factorial experiment
- Conclusion
- Chapter 53. Group allocation
- Key points
- Why it matters?
- Advantages of cluster-randomized trials
- Pitfalls of cluster-randomized trials
- Variations on cluster-randomized trials
- Get started
- Resources
- Chapter 54. Hybrid design
- Key points
- Why it matters
- Hybrid design in clinical trials
- Geting started
- Potential pitfalls to avoid
- Resources
- Chapter 55. Large, pragmatic trials: designs, measures and classic examples
- Key points
- The pragmatic clinical trial
- Real-world examples
- Get started: action items
- Potential pitfalls
- Chapter 56. Equivalence and noninferiority
- Key points
- What is an equivalence or noninferiority study?
- Benefits and limitations
- How to design an equivalence or noninferiority study
- Examples of noninferiority and equivalence trials
- Research team and roles
- Budgetary considerations and funding
- Summary
- Get started
- Potential pitfalls
- Resources
- Chapter 57. Adaptive: design, measures, and classic examples
- Introduction
- Study design
- Subtypes
- Examples
- Get started
- Chapter 58. Principles and methods of randomization in research
- Key points
- Get started/action items
- Pitfalls
- Overview
- Types of fixed randomization
- Types of adaptive randomization
- Randomization in clinical trials
- Randomization tools
- Chapter 59. Blinding: who and how?
- Key points
- Why it matters?
- Introduction
- Blinding methods
- Assessment, documentation, and reporting
- Get started
- Potential pitfalls
- Real-world examples
- Resources
- Chapter 60. Multicenter considerations
- Key points
- Introduction
- Practical considerations
- Budgetary considerations
- Role of social media
- International considerations
- Potential pitfalls to avoid
- Get started
- Real-world examples
- Resources
- Chapter 61. Registries
- Key points
- Introduction
- Registries
- Registry-based studies
- Designing a registry
- Registry trials
- Designing a registry trial
- Potential pitfalls of registry trials
- Real-world examples: additional contemporary examples of registry trials
- Budgetary considerations
- Resources
- Chapter 62. Phases of clinical trials
- Key points
- Why it matters
- Understanding phases of a clinical trial
- Challenges in different trial phases
- Real-world examples
- Getting started
- Potential pitfalls
- Resources for further reading
- Chapter 63. IDEAL framework
- Key points
- “Why it matters?”
- Description, evolution, and adaptations of the IDEAL framework
- Real world examples of IDEAL framework stage application
- Get started
- Potential pitfalls to avoid
- Resources
- Chapter 64. Artificial intelligence methodology in clinical research
- Key points
- Chapter in brief
- Introduction: What is Aartificial Iintelligence (AI)?
- Difference between AI and standard predictive methods
- Section I. Application of AI in clinical trials
- Section II. Future trends of AI applications in research
- Section III. Practicalities for developing an AI solution
- Chapter 65. Patient perspectives
- Key points
- Why it matters
- Patient perspectives
- Get started
- Pitfalls to avoid
- Resources
- Part VII. Clinical: preparation
- Chapter 66. Sample size
- Key points
- “Why it matters?”
- Introduction to methodology
- Elements of sample size calculations
- Additional considerations
- Get started
- Potential pitfalls
- Real world examples
- Resources
- Chapter 67. Budgeting
- How to determine a budget?
- Get started
- Chapter 68. Medical ethics and review boards
- Key points
- “Why it matters?”
- Ethical pillars in human research
- Institutional review board process
- Informed consent and vulnerable populations
- Conclusions
- Get started
- Pitfalls to avoid
- Real-world examples
- Resources
- Chapter 69. Regulatory considerations for new drugs and devices
- Key points
- Introduction
- Data collectable on a nonapproved medical product
- Issues with regulatory agencies
- Get started
- Real-world examples
- Resources
- Chapter 70. Funding approaches
- Key points
- Introduction
- Sources of funding
- Applying for a grant
- Reasons for failure
- Conclusion
- Real-world translational surgical research project publications
- Chapter 71. Subject recruitment
- Key points
- Why it matters?
- Subject recruitment
- Get started
- Pitfalls to avoid
- Resources
- Chapter 72. Data management
- Key points
- Why it matters
- Research data management
- Real-world examples
- ESTS database optimized practices
- ESTS database pitfalls
- Pitfalls to avoid
- Get started: action items
- Chapter 73. Quality control
- Key points
- Why it matters?
- Terminology
- Quality management plan—data and safety monitoring plan
- Get started
- Potential pitfalls—common deficiencies10
- Real-world examples
- Resources for further reading
- Chapter 74. Statistical software
- Key points
- SAS
- SPSS
- R
- STATA
- Get started
- Potential pitfalls
- Real-world examples
- Resources
- Chapter 75. Case report forms: harm and quality of life
- Who performs a case report form?
- When is a case report form done?
- How is a case report form designed?
- Why are cases report forms done?
- Consequences of proper management and mismanagement of case report forms
- Sample images outlining the contents of case report forms
- Inclusion/exclusion criteria sample (Illustrated in Fig. 75.3)
- Concomitant medications form sample (Illustrated in Fig. 75.4)
- The value of CRFs in harm and quality of life
- Potential pitfalls to avoid
- Pitfall #2: underrating the benefit of technology
- Pitfall #3: failure of specification of the inclusion and exclusion criteria
- Real-world examples of case report forms
- Resources
- Chapter 76. Subject adherence
- Defining adherence
- Approaches to measuring adherence
- Determinants of adherence
- Ethical considerations
- Determining successful adherence
- Moving forward
- Chapter 77. Survival analysis
- Key points
- Introduction
- Survival analysis: Real-world examples
- Kaplan–Meier method: Real-world examples
- Log-rank test (Peto-Mantel-Haenszel test): Real-world examples
- Cox model: Real-world examples
- Potential pitfalls
- Get started
- Resources
- Chapter 78. Monitoring committees in clinical trials
- Key points
- Why it matters
- Roles and functioning of a DSMB
- When is a DSMB needed
- Membership of DSMB
- Get started
- Real-world examples
- Potential pitfalls
- Resources for further reading
- Part VIII. Regulatory basics
- Chapter 79. FDA overview
- Key points
- The FDA and why it matters
- A brief history
- FDA today
- Is my product regulated?
- Final points
- Resources
- Examples
- Chapter 80. Investigational new drugs
- Introduction
- Clearance overview
- Preclinical
- Clinical
- Clearance
- IND maintenance
- Common challenges
- Funding
- Get started
- Chapter 81. Drug development
- Key points
- Introduction
- Drug development
- Preclinical research
- Clinical trial phases
- FDA review
- FDA postmarket safety monitoring
- Get started
- Potential pitfalls
- Real-world examples
- Resources
- Chapter 82. Devices
- Key points
- Why it matters?
- Devices
- Get started
- Pitfalls to avoid
- Real-world examples
- Chapter 83. Regulatory basics: radiation-emitting electronic medical products
- Key points
- Introduction
- Process/pathways
- Components
- Examples
- Common challenges
- Budgetary considerations funding resources
- Pitfalls to avoid
- Relevant literature examples of regulations governing radiation-emitting medical products
- Getting started
- Chapter 84. Orphan drugs
- Key points
- Introduction
- Orphan drugs
- Regulatory process and pathway
- Examples of orphan drugs
- Challenges to orphan drug development
- Budgetary considerations for orphan drug development
- Get started
- Chapter 85. Biopharmaceuticals
- Key points
- Introduction
- Biopharmaceuticals
- Regulatory process and pathway
- Examples of biologics
- Challenges to biopharmaceutical development
- Get started
- Chapter 86. Combination products
- Key points
- Introduction/Why it matters
- Defining combination products
- United States FDA approval process for combination products
- Common challenges in the FDA approval process
- Financing considerations in combination product development and funding resources
- Getting started
- Potential pitfalls
- Real-world examples
- Resources
- Chapter 87. Foods
- Introductory section/Why it matters
- Key points
- Common challenges
- Potential pitfalls
- Get started
- Real-world examples
- Chapter 88. Cosmetics
- Process/pathways
- Components
- Common challenges
- Get started
- Potential pitfalls
- Real-world examples
- Chapter 89. Non-US regulatory
- Key points
- Introduction
- Good clinical practice
- Key legislation and organizations
- Regulatory body approvals
- Informed consent
- Clinical trial information
- Real-world examples
- Get started
- Common challenges
- Potential pitfalls
- Resources
- Part IX. Clinical implementation
- Chapter 90. Implementation research
- Key points
- Introductory section\why it matters
- Get started
- Potential Pitfalls
- Theoretical basis of implementation research
- Approach to implementation research
- Implementation research in surgery: real-world examples
- Funding for implementation research in surgery
- Chapter 91. Design and analysis
- Overview
- Objectives
- Commonly used methodologies
- Measurement challenges, fidelity, and external validity
- Dissemination
- Three, illustrative, theoretical/recently published examples
- Getting started
- Potential pitfalls
- Real-world examples
- Resources section
- Chapter 92. Population- and setting-specific implementation
- Key points
- Introductory section/Why it matters
- Ethnography and implementation
- Individualized support within a multitier system
- Improved colorectal cancer screening by reducing health disparity
- Challenges and pitfalls of translating interventions into population health: Potential pitfalls
- Real-world examples
- Part X. Public health
- Chapter 93. Public health
- Key points
- What is public health?
- Real-world examples: theory in action
- Getting started
- Resources
- Chapter 94. Epidemiology
- Key points
- Why it matters
- Epidemiology
- Get started
- Pitfalls to avoid
- Resources
- Chapter 95. Factors in surgical public health and health disparities research
- Key points
- Introduction
- Behavioral
- Social
- Health systems
- Environmental
- Biomedical
- Conclusion
- Get started
- Potential pitfalls to avoid
- Real-world examples
- Chapter 96. Good questions in public health research
- Key points
- Introduction
- Question frameworks
- Public Health Pentagon
- Equipoise
- Community
- Impact
- Implementation
- Public policy
- Conclusion
- Get started
- Pitfalls to avoid
- Real-world examples
- Chapter 97. Population and environmental specific considerations
- Key points
- Why it matters?
- Population and environmental specific considerations
- Get started
- Pitfalls to avoid
- Resources
- Chapter 98. Law, policy, and ethics
- Overview
- Objectives
- Methods
- The impact of law and policy change
- Challenges
- Conclusions
- Get started
- Pitfalls to avoid
- Resources
- Chapter 99. The role of healthcare institutions in translational surgical research
- Key points
- Introductory section/why it matters
- Healthcare institutions' role as clinical trial sponsors
- Academic health centers
- Community hospitals and managed care organizations
- Not-for-profit organizations and charitable foundations
- The biomedical, pharmaceutical, and medical device industries
- Venture capital
- Contract research organizations
- Potential pitfalls
- The role of the clinical research associate
- Getting started
- Real-world examples
- Translational research accelerators
- Summary
- Chapter 100. Public health institutions and systems
- The public health system
- Public health system functions
- Governmental versus nongovernmental public health
- Conclusion
- Part XI. Practical resources
- Chapter 101. Data presentation
- Key points
- “Why it matters?”
- Presenting data
- Types of data
- Data presentation
- Developing and delivering and effective presentation
- Common pitfalls
- “Get started”
- Chapter 102. Manuscript preparation: an overview for authors
- Key points
- Why it matters?
- Preparation
- Manuscript sections
- Submission considerations
- Final thoughts
- Chapter 103. Building a team
- Key points
- Introduction/Why it matters
- Identify a mentor
- Develop core competencies for interprofessional collaboration
- Avoid these pitfalls
- Collaborate with statisticians, coordinators, and laboratory managers
- Get started
- Real-world examples
- Resources
- Chapter 104. Patent basics
- Key points
- Introductory section\Why it matters
- Intellectual property
- Overview of patent filing process and fees
- Patent content and timeline
- Intellectual property in research
- Patenting biotechnology
- Get started
- Summary and pitfalls
- Resources
- Chapter 105. Venture pathways
- Key points
- Introduction
- Types of pharmaceutical companies3
- Basics of beginning a medical venture
- Additional business pathways
- Pitfalls: common deficiencies
- Getting started
- Chapter 106. Small Business Innovation Research and Small Business Technology Transfer
- Key points
- Introduction
- SBIR/STTR program
- The phases of the program
- Eligibility
- Women-Owned Small Business and Socially and Economically Disadvantaged Small Business
- Participating agencies
- Grants versus contracts
- Get started
- Potential pitfalls
- Real-world examples
- Resources
- Chapter 107. Sample forms and templates
- Key points
- Why it matters
- Sample forms and templates
- Get started
- Pitfalls to avoid
- Resources
- Glossary terms
- Index
- No. of pages: 768
- Language: English
- Edition: 1
- Published: March 22, 2023
- Imprint: Academic Press
- Paperback ISBN: 9780323903004
- eBook ISBN: 9780323906302
JB
Jeffrey A. Bakal
Jeff Bakal PhD, P.Stat. is the Program Director for Provincial Research Data Services at Alberta Health Services which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform and Health Service Statistical & Analytics Methods teams. He has over 10 years of experience working with Health Services data and Randomized Clinical Trials. He completed his PhD jointly with the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen's University. He has worked on the methodology and analysis of several international studies in business strategy, ophthalmology, cardiology, geriatric medicine and the analysis of kinematic data resulting in several peer reviewed articles and conference presentations. His current interests are in developing statistical methodology for time-to-event data and the development of classification tools to assist in patient decision making processes.
Affiliations and expertise
Division General Internal Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton Alberta, CanadaAE
Adam E.M. Eltorai
Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.
Affiliations and expertise
Harvard Medical School, Boston, MA, USAPN
Paige C. Newell
Paige Newell MD received her Bachelor of Arts in History of Art and Architecture from Harvard University, and subsequently received her Doctor of Medicine from Lewis Katz School of Medicine at Temple University. She started general surgery residency at Brigham and Women's Hospital in Boston, MA in 2018, and spent her two years of dedicated research time from June 2020 - June 2022 as the Vicky and Joseph Safra Cardiac Surgery Clinical Outcomes Research Fellow within the Division of Cardiac Surgery at Brigham and Women's Hospital and as a research fellow for the Center for Surgery and Public Health. Her research interests include socioeconomic disparities in cardiac surgery outcomes and barriers to access to high quality care. After completing general surgery residency she plans to complete a fellowship in cardiothoracic surgery.
Affiliations and expertise
Brigham and Women’s Hospital, Boston, MA, USAAO
Adena J. Osband
Adena Osband, MD is a graduate of the University of Pennsylvania and New Jersey Medical School. She is currently a transplant surgeon and director of the living donor program at Rhode Island Hospital, with over 15 years in practice. She also holds the positions of associate professor of surgery and director of surgical intern education at the Warren Alpert Medical School of Brown University.
Affiliations and expertise
Department of Surgery, Warren Alpert Medical School of Brown University, Providence, RI, USARead Translational Surgery on ScienceDirect