Emerging Subspecialties in Neurology: Clinical development

Opportunities for neurologists

Clinical development opportunities for neurologists exist at pharmaceutical and device companies, contract research organizations, academic research organizations, regulatory agencies (e.g., US Food and Drug Administration, European Medicines Agency), and as an independent contractor. Increasingly, industry has partnered with academia to reduce rising research and development costs and take advantage of cutting-edge research at academic institutions. Industry sponsors potentially benefit from the specialized technology and expertise available in the academic environment. In this setting, academic neurologists work within their research area on innovative projects of interest to industry.

Roles

Clinical development activities of neurologists usually take advantage of their medical training and clinical experience. For example, in the early stages of a novel therapeutic's clinical development, neurologists must understand and communicate the potential clinical benefits of the new agent, disease populations to evaluate in clinical studies, and perceived safety risks that require monitoring.

To evaluate the desired clinical benefits and minimize safety risks to research volunteers and patients, clinical development neurologists often offer their skills in multiple roles. These include activities such as developing clinical trial medical monitoring, and safety signal detection protocols; assisting with development of clinical trial reports, regulatory documents, and investigator brochures; directly monitoring the safety of trial participants; ensuring the medical accuracy of printed materials, such as product labels and publications; answering medical questions from investigators; and providing therapeutic training for internal staff, investigators, and contractors.

Functions

Neurologists can contribute to clinical development in several capacities; notably, as site investigator, clinical research physician on a clinical development team, or an external consultant. Neurologists with appropriate training may also support clinical development as a clinical pharmacologist.

Neurologists in industry

Within a pharmaceutical/device company or contract research organization, neurologists usually provide services as a medical affairs, clinical research, or safety physician. Due to the complexities of the therapeutic development process, neurologists often work in multidisciplinary teams with representatives from multiple functions (e.g., clinical operations, regulatory affairs, statistics). Importantly, the contributions of the neurologist will be interpreted in the context of input from these other functions that also play critical roles.

Pathways for entering industry

Neurologists may enter clinical development in an academic or industry environment directly after completing their clinical training. Most commonly, neurologists participate in clinical development as an investigator in pharmaceutical industry–sponsored clinical trials. Typically, their role starts as a subinvestigator in a clinical trial during training or as junior faculty, leading to a principal investigator role with increasing experience and participation in a variety of trials. Neurologists perceived as experts in their respective fields also sit on advisory boards to provide scientific advice on concepts and the development of clinical trial protocols. In some trials, external physicians serve on data monitoring committees that evaluate safety or efficacy data. After participating in clinical trials as an investigator or advisory board member, neurologists may decide to pursue clinical development as a career in the pharmaceutical industry.

Similarities and differences among clinical medicine, academic research, and clinical development

In contrast to clinical practice, where neurologists try to achieve a clinically meaningful change in disease status in the individual patient, clinical development of a therapeutic entity emphasizes the population response. In the industry setting, many team members share decision-making responsibilities and regulatory agencies (and increasingly payers) strongly direct clinical development activities. In translational or basic academic research, decisions are more centralized and often based on personal interests, skill sets, and funding opportunities. Clinical practice decisions may also be influenced differently by payers, legislation, and legal considerations. Additional challenges for a career in the pharmaceutical industry may include differences in terminology, organizational structure, and the highly regulated environment. Although seemingly straightforward, the distinctions between these environments and the necessary change in mindset can be difficult for neurologists who enter clinical development from a prolonged period in clinical practice or academic research. Despite these differences, communication, teamwork, and a strong desire to improve patient health are common elements in all these settings, while adherence to good clinical practice guidelines should be a feature of all clinical research.

For many neurologists, clinical development is a nontraditional career path. However, they may be attracted to the challenging work on the cutting edge of therapeutics, access to innovative technologies, and involvement in rapidly advancing clinical research without the stress of maintaining grant funding. Additional potential attractions include the often-employed multidisciplinary team approach and collaboration; a sense of accomplishment when a new medicine is delivered to the market for patients with unmet medical needs or a study is successfully completed; varied daily activities; and the need, during the development lifecycle of a therapeutic entity, to overcome ever-changing challenges. Neurologists may be enticed by the change in responsibilities, perceived lifestyle benefits, prior positive experiences interacting with industry personnel, and the global scope of clinical development.

Training opportunities

In several countries, pharmaceutical medicine is a recognized medical specialty with dedicated training programs and licensing.⁵ For instance, in the United Kingdom, the Pharmaceutical Medicine Specialty Training program is a multiyear modular training program, including a module on clinical development, that leads to registration with the General Medical Council as a specialist in pharmaceutical medicine.⁶ Particularly in Europe, advanced training opportunities in pharmaceutical medicine often confer a master's degree.^5,7 Given the global nature of the pharmaceutical industry, the International Federation of Associations of Pharmaceutical Physicians harmonized these training programs to provide a balanced education and professional degrees that are recognized between countries. These structured pathways do not exist in the United States and training is often individualized to the needs of the neurologist and his or her organization.

When initiating a clinical development career in industry, the highly regulated environment and inadequate exposure of many neurologists results in a protracted “startup time” with substantial training costs to their organization and lower productivity that can be reduced by prior training. Consequently, for clinical development positions, neurologists with prior training or experience will be particularly attractive.

Several opportunities exist to develop skills in therapeutic development, either in preparation for a full-time position or to improve understanding and performance in clinical trials as an investigator (table). Several organizations provide short courses, Webinars, and online courses to acquire knowledge in specific areas of clinical development, as well as longer, usually site-based courses that offer a broad overview of the therapeutic development process.

Neurology-specific structured training opportunities, such as fellowships, are limited. We know of 3 intensive programs that focus on drug development training in the neurosciences (UCB Pharma, Inc., in partnership with the University of North Carolina Eshelman School of Pharmacy, Duke Clinical Research Institute, and Hamner Institutes; University of California, San Diego; and University of Rochester).^8,–,10 Further information on these programs is available on their respective Web sites (table).

Collectively, these programs train future leaders in neurology clinical development. In addition to the knowledge gained, they may also provide other benefits, such as added job opportunities for properly trained neurologists; networking and potential collaborations in clinical studies and other research projects; a larger pipeline of neurologists with drug development expertise that may encourage other trainees to consider training and working in therapeutic development; and a better understanding of the perspectives of the pharmaceutical industry and regulatory agencies.