Clinical research education: Translating science into real-world impact

The biggest pandemic the current generation has seen is the COVID-19 pandemic. Emergency use authorization of various COVID vaccines combined with the rampant spread of falsified information, made vaccine hesitancy a parallel pandemic 1. Historically the impact of innovation driven through Clinical Research has been tainted by communication gap between the pharmaceutical industry and the general public. Addressing this requires bridging the gap between research innovations and communicating the research outcomes.

At the forefront of such Clinical research is a Principle Investigator (PI). PIs are usually licensed physicians and experts in their field of medical practice. However, in the United States, the medical school curriculum does not offer formal training in clinical research. 

Clinical research is a complex endeavor with aspects of study design, regulatory compliance, consideration of Clinical equipoise balanced with research ethics, Good clinical practices (and relevant GXPs), and data presentation (post management and analysis). Findings in clinical research need to be communicated well to gain public trust. A brunt of this burden falls on the already overworked primary care physicians and nurses. This could be alleviated only when healthcare workers have access to a good fund of knowledge of the results of clinical research. Such knowledge creation happens when there are well trained physicians involved in the research process as PIs. Many people, including healthcare workers are missing out on being involved in medical breakthroughs and providing equitable distribution of generalizable evidence due to the lack of education. This impact is magnified when the lens is through that of a physician who becomes a PI. Success of well-trained PIs is reflected when the complicated technical aspects are well communicated to patients. There will be reduced “missed opportunities” when it comes to availing new and enhanced treatments.  

Here are three important considerations for why clinical research education in PIs is so important!! 

Patient Empowerment: The primary goal of Clinical research is to improve patient outcomes. “Patient is the Key Stakeholder”. When patients turn participants in clinical research, they improve generalizability of studies. Not when patients are cornered into research due to absence of an alternate recourse. The role of a trained PI in disseminating research information in an understandable and unbiased manner along with educating research participants are the corner stones of improving patient empowerment. 

Evidence based medicine: Providing healthcare through modern medicine has always been referred to as “practice”. This is because there is always scope for improvement with the ultimate goal always being the patient. Through this lens, medical practice has evolved to be preferentially “evidence-based”. Evidence based medicine evolves through robust evidence generated from clinical research. To learn interpretation and importance of such clinical research findings is important for healthcare providers to provide best possible treatment options for patients.  Through trained PIs, effective clinical research education addresses potential concerns about evidence-based medicine by disseminating information in a regulated fashion. 

Public trust in science:  Many historical incidents such as the Nazi medical experiments in concentration camps, the Havasupai case, the HeLa cells, etc. have created a general mistrust in the public. Pharmaceutical industry has not done much to deal with these situations by communicating properly with all stakeholders (including patients). This is evident in current day medical practice where we saw many patients refusing life-saving vaccines, including COVID vaccines that effectively helped slow down the pandemic.  

Addressing this mistrust requires PIs, who are the forefront of innovation and medical practice, to be effectively educated in clinical research so that they can eventually contribute to the process of clear scientific communication. 

Integrative strategies to enhance clinical research education in PIs begin with medical school curriculum. While there is ample focus on basic science research in pre-medical track for college students and medical school students, there is limited exposure and training in clinical research. Integrating the key aspects of clinical research including ethical practices, GCPs, designing research, managing trials as PIs, handling regulatory affairs, basics in data analytics and management are few important areas of consideration. These considerations would enhance future physician’s capability to successfully navigate clinical research and thereby contribute to a robust system of evidence-based medicine. It would also give physicians the capability to successfully contribute to PI roles where they can effectively communicate with research staff and patients, thereby augmenting the generalizability of clinical research outcomes. 

Empowering change through education is the cornerstone of a society. This is furthermore true for the scientific society and it’s impacts on the population in general. Making science meaningful and accessible to everyone would start with educating healthcare providers, especially physicians with potential to become investigators in clinical research. 

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