As the 2010s draw to a close, pharmaceutical and medical device development is rapidly evolving, raising the stakes for master of business administration (MBA) students looking to keep up with the changes and break into the health care industry. Today’s research and development (R&D) departments are exploring many novel approaches to medical treatment, ranging from more precisely targeting RNA molecules to producing silicon chips that can be embedded into human cells.
Transforming this research into safe, usable therapeutics will require a mix of proficiency with modern technologies — such as data analytics, artificial intelligence and cloud computing — and expertise in proven practices for clinical research administration. This combination should fuel the drive toward safer, higher-value medical products and greater financial efficiency across organizations. However, there are some significant hurdles to clear en route to these goals, placing a premium on the skills cultivated by a healthcare MBA (HCMBA).
What are the current challenges in clinical research administration?
PricewaterhouseCoopers (PwC) has attributed such challenges to something it calls the New Health Economy. This phenomenon refers to a complex set of converging trends in the health care sector, including:
● The changing demands of payers (health plans), which have developed increasingly sophisticated processes for evaluating the utility of drugs. In some cases, they have been skeptical of expensive new pharmaceuticals similar to existing, less costly treatments.
● Slow growth rates in drug sales. According to PwC, the compound annual growth rate was projected at only 5.1 percent from 2013 to 2020. This has consequences for profit margins, which already struggle because of significant R&D spending per molecular entity. Research teams are under pressure to find savings without sacrificing quality.
● Increased emphasis on value in health care delivery. Providers have more financial incentives to offer treatments that produce the best possible results the first time, instead of relying on sheer volume of procedures, high value or otherwise.
At the George Washington University (GW), MBA students can prepare themselves for all of these emerging challenges in clinical research. Thanks to a partnership between the School of Business and the School of Medicine and Health Sciences (SMHS), MBA candidates can earn an additional graduate certificate in Clinical Research Administration (CRA), which covers the R&D of new therapeutics for improved patient care.
How students can become experts in clinical research management
The certificate in clinical research administration from SMHS instructs students in the key processes and concerns that shape clinical trials and product development. It requires completion of 15 credit hours within the CRA core, along with one three-credit-hour elective. Let’s take a look at the core curriculum:
Critical Analysis in Clinical Research
This class delves into medical literature review and other academic approaches to clinical research. The goal is to ensure MBA students, as eventual researchers, can establish defendable positions and understand multiple perspectives on a common set of information.
Developing a new drug is a complicated and lengthy undertaking. On top of the clinical and scientific challenges, there are also many regulations to navigate, risks to assess and ethics to consider. In this course, students learn how to address these issues during development while implementing lifecycle management for consistent structure.
Partnership with Human Subjects
Before they are evaluated for use among the public, pharmaceuticals and medical devices are tested on human subjects. This class teaches students how to recruit, engage, interact with and retain these individuals while complying with all applicable regulations and ethical standards.
The Clinical Research Industry
Clinical research is not performed by solitary scientists in isolated labs. Instead, it’s a team-oriented domain requiring adept project management, informed decision-making and cross-cultural competency. This course provides the necessary background in these areas so MBA graduates are ready to lead R&D teams.
Quality and Risk Management
Risk management is pivotal to successful clinical research, due to the high stakes for the health of human subjects as well as the overall costs and regulatory complexity of putting them through trials. Some of the specific risks include:
● Conducting trials at global scale, for possible marketing approval of products in multiple countries, each with its own regulations.
● Ensuring proper design so results are scientifically reproducible and indicative of the possible side effects of a given treatment.
● Controlling the expenses associated with clinical research, which are substantial and a drag on profit margins, according to the PwC study.
● Preventing reactive problem management and instead identifying issues early before they invite additional scrutiny and become costlier to contain.
The clinical research administration certificate within the GW HCMBA
CRA is one of several possible certificate tracks within the GW HCMBA offered through the SMHS partnerships. The other options are Clinical Research Practice, Clinical and Translational Research, Health Care Quality and Regulatory Affairs. Each certificate fulfills the requirement of earning 12 credits of health care-focused electives.
In addition to these electives, all students in the program must complete 31.5 credits in the program core and 12 credits in general electives. MBA candidates with a certificate in CRA are well-prepared to pursue in-demand positions such as medical scientist. According to the U.S. Bureau of Labor Statistics, the number of openings for this occupation is expected to increase by 13 percent between 2016 and 2026, faster than the average for all professions.
To learn more about applying to the GW HCMBA, visit the main program page. There, you can answer a few simple questions and receive our free brochure with additional information. This webinar also dives into the numerous opportunities at SMHS, including the CRA certificate.