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Insights on Clinical Research in the Medical-Practice Setting


William R. Brown, MD, Professor Emeritus, University of Colorado School of Medicine

February 2023

Clinical research is a branch of medical science that investigates within medical practice the safety, risk, and effectiveness of medications, medical devices, diagnostic tests, and treatment regimens. It helps physicians identify the best and current recommendations for care of patients through critical assessment of diagnoses, therapy, cost effectiveness, screening, prevention, prognosis, and risk assessment. Although clinical research is sometimes regarded as unimportant or inferior in quality, it can be essential to bringing the advances of basic research to the bedside and for achieving high-level patient care. In this short article, we illustrate many of the important and attractive features of clinical research, including the opportunities to publish one’s research in respected medical journals. We also highlight and acknowledge the personnel needed for the conduct of quality clinical research.

Clinical research compared with clinical practice

Clinical research differs from clinical practice of medicine, although they share some features. Importantly, clinical research can be conducted in the same setting as that of clinical practice. Clinical research tests for and validates the efficacy or effectiveness of practice methods. Clinical practice, on the other hand, uses established, evidence-based, diagnostic methods and treatment, and it relies heavily on individual physician experience, which may not be proven by empirical research.

Clinical research compared with academic research

Academically oriented physicians, especially those who are early in their careers, often face a career choice: whether to pursue clinical research or basic science research. While both pathways present challenges, clinical research offers advantages over basic science research that should be considered in the career-decision making process. Some of these advantages are:

• Fewer resources needed for clinical research, as many needs can be met within the framework of clinical practice
• Full-time commitment to the research lab is not required
• Does not depend on funding from governmental of private sources
• Projects can be carried out as part of clinical practice
• Specially trained technicians are not needed
• Specialized training in laboratory techniques is not needed
• Specialized, expensive equipment is not needed
• Results are immediately relevant and applicable to clinical practice (no “bench-to-bedside” delay)

Publishing clinical research

Publishing in reputable scientific journals is not exclusively for academic research. Indeed, clinical research allows unique opportunities to see how established findings can be applied in the real world. Many of the top academic and medical journals regularly publish studies that have been conducted in clinical settings. Clinical investigators must keep in mind, though, that journals give publishing preference to observations or findings that are new, innovative, and significant in patient care. Articles that are redundant, repetitious of published work, or trivial in content are unlikely to be published.

Clinical trials

One of the advantages of working in clinical research is the opportunity to participate in clinical trials. Clinicians, either in training or in practice, can be involved in the enrolment of patients into trials or care of patients who are in trials. Clinicians may also participate in data collection and analysis and in writing and publishing trial results. Examples of clinical trials that can be especially interesting to clinicians include:

• Comparative effectiveness of pharmaceutical agents (e.g., various chemotherapeutic regimens)
• Risk assessment and prediction of adverse outcomes (e.g., LDL and risk of myocardial infarction)
• Evaluation of the reliability of diagnostic tests (e.g., carcinoembryonic antigen, alpha fetoprotein)
Evaluation of the efficacy of innovative treatments for common diseases (e.g., hepatitis, nonalcoholic fatty liver disease).

Systematic review

Clinical research does not always require large and complex study design. In fact, some of the simplest studies that require only a modest investment in time are systematic reviews that use clinically available tools and information. The findings of these types of studies are often clinically impactful. Indeed, even single-center systematic reviews can reveal useful findings about the efficacy of two different therapies.

Database review

A third type of clinical study are database reviews, which involve mining information from medical databases. The retrospective nature of this type of clinical research makes it comparatively easier to approve and conduct. One advantage of database reviews is that they often have large sample sizes as well as relatively low costs. However, database reviews may require more sophisticated statistical analysis. Importantly, database reviews can be useful for identifying risk factors for serious pathologies.

The basic requirements for clinical research

One of the advantages to clinical research is that it often does not impose added cost to patient care. Moreover, unlike academic research, clinical research typically requires access to medical information and common medical journals (New England Journal of Medicine, JAMA, Lancet) rather than highly specialized basic journals (Cell, Science, Nature). Ultimately, the main requirements are a curious mind and commitment to the advancement of clinical knowledge and practice along with approving, interested, and selfless patients.

The professional rewards of the clinical research career

Productive, meaningful clinical research can be as rewarding as basic science research in many ways. It can lead to academic advancement and stature of the clinician, personal intellectual gratification, improved care and education of patients, and satisfaction in the mentoring and development of trainees.

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