The Clinical Research Handbook: A Practical Guide To Designing, Conducting And Publishing Clinical Research

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:

• Reading relevant peer-reviewed literature.
• Formulating novel hypotheses.
• Formatting and writing a manuscript.
• Describing different types of data sources such as institutional datasets and many national databases.
• Describing how to take data and perform statistical analysis using prominent packages of RStudio, and we additionally provide basic source code.
• Discuss the creation of online predictive calculators which are becoming even more common in literature today.
• Discuss an introduction to intellectual property and grant writing.

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.

Mohammad Faizan Khan is a medical student at Indiana University School of Medicine and a distinguished Bepko Scholar from IUPUI. As a Valedictorian at Eman Schools, he demonstrated a lifelong commitment to academic excellence. A passionate researcher, Mohammad has authored multiple publications in peer-reviewed journals, including the Journal of Neuro-Oncology, Journal of Clinical Neuroscience, and World Neurosurgery. He has also contributed articles to The Neurosurgical Atlas, furthering education in complex neurosurgical procedures. In The Clinical Research Handbook, Mohammad provides a practical guide to designing, conducting, and publishing clinical studies, empowering medical students and early-career professionals to make meaningful contributions to research. Outside of medicine, Mohammad enjoys video games and quality time with his wife.

Nolan J Brown is a medical writer and co-author of The Future of Technology in Medicine: From Cyborgs to Curing Paralysis, a World Scientific publication. He earned his MD/MBA from the University of California, Irvine. He aspires to pursue fellowship training in skull base and cerebrovascular neurosurgery. Outside of the clinic, his research has led to multiple patents, including a novel dural repair technique with applications in neurological surgery. He has also contributed to developing a novel, multimodal liquid biopsy assay for enhanced detection of GBM, the most universally lethal form of brain cancer. His main research interest is leveraging spatial transcriptomics to map brain tumor expression profiles and establish molecular signatures from which therapeutic targets can be derived. Guided by exceptional mentors since his undergraduate days at UC Irvine, Nolan has engaged in cutting-edge research and developed a passion for neurosurgery that he foresees will translate to a lifelong journey spent in the operating room, helping patients recover from potentially life-altering neurological conditions. He cites one of his main motivations as a desire to optimize healthcare operations, and his ultimate goal is to ensure that no patient's needs go unmet.

Julian Gendreau's passion for neuroscience began in medical school at Mercer University, where he observed a glioblastoma craniotomy alongside a mentor. This experience, combined with the vast unknowns in neuroscience, solidified his decision to pursue neurosurgery. During his training, Julian engaged in clinical research on brain tumors and neurosurgical outcomes. He earned a Master's in Applied Biomedical Engineering from the Johns Hopkins Whiting School of Engineering, focusing on improving surgical outcomes through machine learning applications. Beyond research, Julian is dedicated to advancing neurosurgery by integrating technology and evidence-based medicine. He is the author of The Future of Technology in Medicine: From Cyborgs to Curing Paralysis, exploring the transformative role of emerging medical innovations.

Ronald Sahyouni, MD, PhD, is a Neurosurgery Resident at the University of California, San Diego School of Medicine, dedicated to advancing neuromodulation and medical device innovation to restore function in patients with paralysis. His passion for neuroscience began in high school and led him to the University of California, Berkeley, where he double-majored in Neurobiology and Psychology to explore brain function at both microscopic and systemic levels. He conducted neuropsychological evaluations at the UC Davis Alzheimer's Disease Center, gaining firsthand insight into the challenges of treating neurological disorders. Committed to transforming patient care, Ronald pursued an MD and PhD through the Medical Scientist Training Program (MSTP) at the University of California, Irvine. His research focuses on cutting-edge neuromodulation technologies and implantable medical devices aimed at restoring motor function in patients with stroke and spinal cord injury. He has contributed to education through his work at Khan Academy and is the author of The Future of Technology in Medicine: From Cyborgs to Curing Paralysis and Alzheimer's Disease Decoded, which explore the evolution of medical technology and neurodegenerative disease treatment. Outside of medicine, he enjoys dog training and exploring new ways to bridge neuroscience and technology to improve patient outcomes.

Aaron Cohen-Gadol is a professor of neurosurgery at the Keck School of Medicine of USC. He is one of the world's leading neurosurgeons, specializing in complex brain and spine tumors, including meningiomas, gliomas, pituitary adenomas, and acoustic neuromas. He has performed over 7,400 complex brain surgeries, more than any other single surgeon in the United States, with his work meticulously documented in the Neurosurgical Atlas, a renowned global resource often referred to as the "bible of neurosurgery." Dr Cohen earned his BA in Bioengineering from the University of California, San Diego, followed by his MD from the Keck School of Medicine of USC. He completed his neurosurgery residency at Mayo Clinic, with advanced fellowship training in epilepsy surgery at Yale University and skull base/cerebrovascular surgery at the University of Arkansas. He also holds a Master's in Clinical Research from Mayo Clinic and an MBA from the Kelley School of Business. As the founder and chief editor of The Neurosurgical Atlas, Dr Cohen has revolutionized neurosurgical education by providing cutting-edge surgical techniques and innovations. He has authored over 560 peer-reviewed publications and contributed to advancements in fluorescence-guided brain tumor surgery. He is the recipient of the prestigious Vilhelm Magnus Medal, regarded as the "Nobel Prize of Neurosurgery," recognizing his transformative contributions to the field. Beyond his clinical and academic work, Dr Cohen remains dedicated to mentorship, research, and advancing neurosurgical care through innovative surgical strategies.