Internal medicine (IM) plays a critical role in clinical research and necessitates a solid understanding of internal medicine research to complete trials successfully. Therefore, a comprehensive understanding of internal medicine in clinical research is crucial for biotech and pharma companies to make informed decisions when selecting a contract research organization (CRO) partner for their next clinical trial. This article aims to provide biotech and pharma companies with insights into internal medicine as a therapeutic area, its coverage of other therapeutic areas and indications, and its landscape within clinical research.

 

What is Internal Medicine in Clinical Research? 

Internal medicine is the medical specialty and therapeutic area that focuses on preventing, diagnosing, and treating diseases in adults, typically without surgical intervention. An internist, or internal medicine physician, applies scientific knowledge and clinical expertise in the care of adult patients across the spectrum from health to complex illnesses and is often an individual’s main healthcare provider who coordinates treatment provided by other specialists.

Internal medicine is the largest medical specialty in the world, and according to the American College of Physicians, nearly 200,000 internal medicine physicians practice in the U.S. Among the wide range of roles and settings internal medicine physicians practice in, there is a strong emphasis on research, from basic science discovery to translating basic science knowledge into clinical practice.

Up to two-thirds of all National Institutes of Health (NIH) clinical research funding is awarded to internal medicine physicians. Departments of Medicine are essential in research in U.S. academic medical centers. Further, clinical and research experience prepares internal medicine physicians to teach medical students, residents, and fellows and to develop the next generation of investigators.

Internal medicine physicians contribute to advancements in research while playing a vital role in clinical care. Internal medicine physicians are skilled at synthesizing data, analyzing and validating medical research, and paving the way for innovative tech and breakthrough treatments to impact patient health outcomes.  

 

Scope of internal medicine  

The internal medicine specialty manages a wide range of diseases and conditions. Physicians may choose to focus on general internal medicine or subspecialize within internal medicine. The subspecialties certified by the American Board of Internal Medicine, for example, include cardiology, endocrinology, gastroenterology, hematology, infectious disease, nephrology, oncology, pulmonary disease, and rheumatology.

Cardiology involves diagnosing, treating, and preventing heart diseases and disorders, and cardiologists manage conditions such as cardiac arrest, arrhythmias, and heart failure. Endocrinology specializes in diagnosing and treating disorders of the endocrine system. Diabetes mellitus is a metabolic disorder characterized by chronic hyperglycemia (high blood sugar levels). Gastroenterology focuses on the digestive system and its disorders. GI specialists, or gastroenterologists, diagnose and treat gastrointestinal tract conditions, including the esophagus, stomach, intestines, liver, pancreas, and gallbladder. Common diseases and conditions in the infectious disease subspecialty include bacterial, viral, fungal, and parasitic infections.  

 

Therapeutic Areas and Indications Covered by Internal Medicine

 

1. Cardiovascular Disease (CVD)  

CVD is the leading cause of death globally, with approximately 17.9 million people dying from CVD each year. CVDs are a group of disorders of the heart and blood vessels and include coronary heart disease, cerebrovascular disease, hypertension (HTN), and other conditions. According to the World Health Organization (WHO), more than four out of five CVD deaths are due to heart attacks and strokes. Of these deaths, one-third occur prematurely in people under 70 years of age6. Top advances in CVD research in 2023 include a study on HTN, a chronic condition where the force of blood against the artery walls is too high. HTN increases the risk of heart disease, stroke, and kidney problems. An example of a CVD clinical trial from 2023 includes a Phase I study investigating Zilebesiran. This investigational drug suppresses the production of angiotensinogen, a protein secreted by the liver believed to play a vital role in increasing blood pressure.  

 

2. Metabolic Disorders 

Metabolic disorders include diabetes, infertility, and thyroid, adrenal, and pituitary gland problems. In the last 30 years, the prevalence of type 2 diabetes has risen dramatically, regardless of income level. According to the WHO, approximately 422 million people have diabetes worldwide, resulting in an estimated 1.5 million deaths attributed directly to diabetes each year. Insulin therapy has evolved with significant improvements in insulin formulation and modes of delivery. In 2023, new biosimilars were approved based on clinical research findings, e.g., Admelog (insulin lispro), an approved Humalog biosimilars, providing more affordable options for patients. 

 

3. Infectious Disease 

The infectious disease, hepatitis B virus (HBV), is a major public health problem, with an estimated 296 million people chronically infected and 820,000 deaths worldwide in 2019. New antiviral and internal medicine immunomodulatory therapies to achieve functional cures are in clinical development. HBV antiviral compounds under clinical evaluation include entry inhibitor Bulevirtide, capsid inhibitors, HBsAg secretion inhibitors, nucleos(t)ide analogs, and viral expression inhibitors.

 

4. Gastrointestinal

Gastrointestinal (GI) diseases encompass a wide range of conditions affecting the digestive system, including the esophagus, stomach, intestines, liver, pancreas, and gallbladder. Common GI disorders include inflammatory bowel disease (IBD), such as Crohn’s disease and ulcerative colitis, irritable bowel syndrome (IBS), celiac disease, and liver diseases like hepatitis and cirrhosis. Recent advancements in GI research focus on biologic therapies, which target specific components of the immune system to reduce inflammation and treat conditions like IBD. One example is the development of novel Janus kinase (JAK) inhibitors that have shown promise in clinical trials for patients with moderate to severe ulcerative colitis who have not responded to conventional treatments. Additionally, fecal microbiota transplantation (FMT) continues to gain traction as a potential treatment for recurrent Clostridioides difficile infection (CDI), with ongoing studies exploring its efficacy for other GI disorders.

 

5. Women’s Health

Women’s health is a broad field covering various conditions that uniquely or disproportionately affect women, including reproductive health, menopause, osteoporosis, and gynecological cancers such as breast and ovarian cancer. Current research in women’s health focuses on improving diagnostic tools and developing targeted therapies for conditions like endometriosis and polycystic ovary syndrome (PCOS), which affect millions of women worldwide. Advances in breast cancer treatment have also been significant, with newer therapies such as CDK4/6 inhibitors and PARP inhibitors showing efficacy in treating hormone receptor-positive and BRCA-mutated breast cancers, respectively. Clinical trials are also exploring the potential of personalized medicine approaches, including genetic and biomarker testing, to tailor treatments to individual patients’ needs.

 

6. Respiratory

Respiratory diseases affect the lungs and other parts of the respiratory system, including chronic obstructive pulmonary disease (COPD), asthma, pulmonary fibrosis, and respiratory infections like pneumonia. According to the Global Burden of Disease Study, respiratory diseases remain one of the leading causes of death worldwide. Recent innovations in respiratory research have led to the development of new biologic therapies, which target specific pathways involved in inflammation and immune response. For instance, monoclonal antibodies targeting the interleukin-5 (IL-5) pathway have been developed for severe eosinophilic asthma, a subtype of asthma characterized by high levels of eosinophils, a type of white blood cell. Additionally, ongoing research is exploring the use of gene therapy and novel inhalation devices to improve drug delivery and efficacy in treating various chronic respiratory conditions.

 

What is the Landscape of Internal Medicine Clinical Research? 

 

Current trends in internal medicine clinical research

 

Collaboration: COVID-19 underscored the internal medicine importance of global collaboration and data sharing in clinical research, particularly for infectious diseases. The current research trend includes sharing data, resources, and best practices to accelerate the pace of disease discovery and the application of research findings across borders.  

Digital and artificial intelligence (AI): AI and digital solutions are increasingly pivotal in clinical trials, spanning patient recruitment and retention, data analysis, and monitoring. Clinical trials benefit from opportunities to streamline processes, enhance accuracy, and discover insights less likely to be found when using traditional approaches11. As an intervention, a behavioral science-informed, point-of-care clinical decision support tool for older adult care resulted in lower annual rates of three outcomes (prostate-specific antigen testing in men aged 76 years and above without previous prostate cancer, urine testing for nonspecific reasons in women aged 65 years and above, and overtreatment of diabetes in patients aged 75 years and older).  

Decentralized clinical trials (DCTs): DCTs and hybrid trials have gained popularity as they deploy digital solutions to facilitate trial activities remotely, including recruitment, enrollment, data collection, and follow-up. DCTs make clinical trials more efficient and patient-centric, allowing for more inclusive and diverse participant populations.  

Trends of key therapeutic areas: The global cardiovascular clinical trials market is anticipated to grow at a compound annual growth rate (CAGR) or 6% from 2024 to 2036, to reach US$11.7 billion by the end of 2036. Growth drivers include the rising incidence of CVDs like cardiac arrest, stroke, and coronary artery diseases, the rise in contract research organizations (CROs) in recognition of their specialized skills and competency in cardiovascular clinical research, and the increase in R&D expenditure. According to a PwC study, the diabetes indication market size in the North American clinical trials industry was expected to grow at a CAGR of 3% to reach US$618.69 by 2028, while the market in Asia Pacific is estimated to be worth US$232.78 million by 2028. In 2024, there is a focus on clinical trials for infectious diseases with global impacts, e.g., HIV/AIDS, hepatitis B, and malaria.  

 

Regulatory landscape 

One key consideration is the shift to accelerated vaccine and therapeutic development and the ability to adapt and change necessary to deliver these accelerated timelines. The ability to adapt research was critical to success, as was regulatory bodies’ willingness to adapt by introducing flexible, fast-track approval processes for promising treatments against infectious diseases. Agility in development and the regulatory process has become a key tool, and 2023 was, in fact, a record year for FDA approvals.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) represent the central regulatory authorities in their respective regions, overseeing the safety, efficacy, and security of drugs, biological products, medical devices, and more. The FDA originated from the Agricultural Division of the Patent Office, established in 1839. Over time, the FDA’s role has evolved to focus primarily on ensuring that medications and medical devices are effective and safe for public use.  

Established in 1995, the EMA’s primary duty is to standardize all systems and procedures throughout its member states’ regulatory organizations. The establishment of the EMA aimed to offer a more equitable and cost-efficient environment for pharmaceutical companies, which previously had to secure separate approvals from each EU country. Additionally, the agency can limit regulations promoting competition among member states.

Read more about the similarities and differences in preauthorization, clinical trials, research review, post-approval monitoring and interagency collaboration, and approval timelines of these agencies here.  

 

Challenges in internal medicine research 

Challenges in internal medicine clinical research include barriers to patient recruitment and retention, underrepresentation of some populations, e.g., women, minorities, and older adults, and a lack of skilled professionals in the clinical research workforce. CROs like TFS HealthScience are well-equipped to address these challenges:

1. Patient recruitment and retention. Read our case study on how TFS rescued a critical Phase III onychomycosis study facing recruitment challenges.

2. Diversity and inclusion. TFS is also experienced in overcoming barriers to inclusion, successfully devising effective strategies for recruiting and retaining participants from diverse backgrounds, and advancing diversity in clinical research.

3. Lack of skilled professionals. With a team of experts in strategic resourcing solutions, TFS has supported clients facing clinical research workforce constraints with short- and long-term solutions for strategic resourcing, as well as recruitment services for permanent hires.  

 

The Importance of Choosing the Right CRO for Internal Medicine Clinical Trials

A specialized internal medicine CRO can add value to internal medicine clinical trials as it understands the unique intricacies, requirements, and constraints of such trials and is equipped with the necessary capabilities, e.g., insights and strategy for regulatory compliance for a therapeutic area in a specific geography. Essential qualities to look for in a CRO specializing in internal medicine include having the specific therapeutic expertise needed, an established footprint in target geographies, the ability to strategize for regulatory compliance, and a clear understanding of the challenges and pain points you and your study face.  

The criteria for selecting a CRO include expertise and experience in internal medicine clinical trials and a proven track record of successful internal medicine trials. The CRO must also have access to a broad network of investigators and sites and robust data management and regulatory compliance.

Learn more about selecting the right CRO here. 

 

Conclusion 

Internal medicine physicians are skilled at synthesizing data, analyzing and validating medical research, and paving the way for innovative tech and breakthrough treatments to impact patient health outcomes. A comprehensive understanding of internal medicine in clinical research is crucial for biotech and pharma companies to make informed decisions when selecting CRO partners. Critical takeaways for selecting a CRO include expertise and experience in internal medicine clinical trials, a proven track record of successful internal medicine trials, access to a broad network of investigators and sites, and ensuring robust data management and regulatory compliance.

 

TFS HealthScience: Your Internal Medicine CRO Partner 

TFS is a mid-sized, global CRO specializing in multiple therapeutic areas, including Internal medicine. The Internal Medicine CRO at TFS combines our internal medicine expertise and operational excellence with local knowledge and the highest quality delivery to help you find the best path to deliver your project on time and within budget. TFS has built an impressive track record of over 350 clinical studies conducted in the past five years and nearly 500 Phase I-IV clinical trials supporting internal medicine and related areas. 

Contact us to find out how we can be your Internal Medicine CRO partner with specialized expertise.