The pharmaceutical and medical device development industries continue to evolve at a rapid pace. This naturally raises the stakes for Healthcare Master of Business Administration students looking to keep up with the changes and break into the healthcare industry. Today’s research and development (R&D) departments are exploring many novel approaches to medical treatment, ranging from new targeted therapeutics for multiple sclerosis and cystic fibrosis to smartphone-linked pacemakers.
Transforming this research into safe, usable therapeutics requires 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, placing a premium on the skills cultivated by advanced degree programs, such as an online Healthcare MBA
What Is Clinical Research?
Clinical research is the process of studying health and illness to derive a better understanding of a disease, treatment or other element of health. It builds the foundation for healthcare innovation on many levels, from breakthroughs in handling a specific disease to medical equipment anchored by cutting-edge technology.
Clinical research breaks down into two categories. The first, observational studies, involves the study of people in normal settings. This can involve data acquired from basic medical exams, health-related tests or surveys. The data gathered by these basic techniques enables clinical researchers to identify healthcare aspects that could be improved or enhanced.
Observational studies can often set up the second category of clinical research — clinical trials. These trials study the effectiveness of care delivery interventions designed to improve or maintain health. These can include a new drug, medical device or medical procedure. The goal behind clinical trials is to determine whether the intervention is safe and effective to use or prescribe. Clinical trials typically require participation from human volunteers, although this only occurs once scientists derive favorable results from lab tests and studies conducted on animal test subjects.
What Are the Current Challenges in Clinical Research Administration?
The rapid pace of COVID-19 vaccine development demonstrated the importance of clinical research. At the same time, it provided a glimpse into the administrative challenges that may arise during the process.
For instance, a December 2020 report published in Frontiers in Medicine cited several examples of clinical research misinformation, explaining how incorrect data pertaining to viral transmission and drug treatment strategies threatened to produce muddled and confusing messages as the world watched for a care-driven solution to the pandemic. This reiterated the importance of monitoring the information available to the public and making every effort to ensure that accurate information is distributed, which in an era of social media and other means of public communication can be difficult for clinical research administrators to manage.
A lack of clinical trial efficiency is another challenge facing clinical research administrators. Issues involving regulatory and approval delays, and struggles in finding volunteers could cause a clinical trial to go longer than anticipated. These delays can have residual effects that can impact a facility’s bottom line.
Once a clinical trial is complete, managing the data poses another potential challenge. A 2021 Applied Clinical Trials article broke down the various forms this challenge can take, including incompatibility between different technology platforms, data adjustments needed to account for trial updates and delays in clinical trial databases going live. As the use of technology and big data analytics increases in clinical trials, creating and maintaining a level of data efficiency may also become increasingly difficult.
Clinical Research Management Courses and Skills
Coursework for the certificate in Clinical Research Administration (CRA) from the George Washington University’s School of Medicine and Health Sciences (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 look at the core curriculum:
Critical Analysis in Clinical Research
This class delves into a 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 a 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 drag on profit margins
- Preventing reactive problem management and instead identifying issues early before they invite additional scrutiny and become costlier to contain
Pursue a Clinical Research Administration Certificate Within the Healthcare MBA
Clinical Research Administration is one of several possible certificate tracks within George Washington University’s Healthcare MBA program offered through the SMHS partnerships. The other options are Clinical Research Practice, Clinical and Translational Research, Healthcare Quality and Regulatory Affairs. Each certificate fulfills the requirement of earning 12 credits of healthcare-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 positions. According to the U.S. Bureau of Labor Statistics, the number of jobs in this occupation is expected to increase by 6% between 2019 and 2029, faster than the average for all professions.
Learn more about how George Washington University’s Healthcare MBA program and its Clinical Research Administration track can help prepare you to pursue your professional goals.