Pharmacists are key members of the healthcare profession, and as medication experts their contribution to the landscape of patient care has expanded significantly over the years. The role of pharmacists has long moved beyond evaluation of medication orders and dispensing. Currently, many of these professionals apply their drug information expertise outside of the traditional hospital or retail pharmacy setting. Clinical research is one of the areas in which the profession has evolved. Several pharmacists are initiating research studies and overseeing projects as principal or co-investigators, while others are supporting researchers as drug information consultants. Despite the evolution of the profession, many health and clinical research professionals are still not fully aware of the unique value that pharmacists can add to their research programs.
As the principal authority on medication information, pharmacists are valuable members of research teams, and research pharmacists play important roles throughout the life-cycle of clinical research projects. They contribute to decisions on study design and methodology, manage investigational drugs, and participate in post-study activities. Study teams that do not include a pharmacist member or research organizations that do not have a full-time pharmacist on staff, may still leverage the expertise of an external research pharmacist, as needed throughout the course of the research study. The team of pharmacists at Rx Research Solutions partner with investigators and research organizations in this way. In these collaborations, the research pharmacist is usually tasked with executing certain specified professional duties to address the unique needs of the study. This gives researchers the flexibility to apply their resources based on the specific needs and schedule of their individual projects.
Research pharmacists help to develop and define research questions, conduct extensive literature reviews to answer relevant clinical questions, advise on the logistical operations of a study, assist with the preparation of study documents to fulfill regulatory and institutional requirements, and address drug information inquiries which arise throughout the course of the study. They contribute to the development of quality study protocols and pen sections such as the study rationale, inclusion and exclusion criteria, pharmacology, dosing parameters, pharmacokinetics, potential adverse effects, and drug interactions. Research pharmacists also write guidelines for managing the adverse effects of investigational drugs, prepare detailed study manuals for use by members of the study team who carry out the operational aspects of the study, and assist in the preparation of patient information materials. These and other tasks are increasingly being be executed by off-site research pharmacists who consult with research teams remotely. This growing trend is particularly cost-effective for investigators or organizations with a scope of work that does not require a full-time or an on-site pharmacist.
At certain points during the life cycle of a clinical research project, research pharmacists in traditional settings such as hospitals and clinical research centers, play a hands-on role. The services of some pharmacies are devoted entirely to research; the staff serves research teams and research participants exclusively. Other research pharmacies operate as a sub-division of a traditional institutional pharmacy. Research pharmacists in these settings manage all aspect of procurement, storage, dispensing, documentation, and return or destruction of investigational drugs. Additional responsibilities include compounding and packaging medications, developing blinding techniques, creating randomization charts, patient counseling, and monitoring patients for potential adverse events. As with all other areas of pharmacy practice, the activities of research pharmacists must be executed under the state and federal laws which govern the practice of pharmacy.
Research pharmacists contribute to the organization and analysis of study data as well as the interpretation of results. Pharmacists also contribute to the oversight of clinical research by serving as members of Institutional Review Boards and Data and Safety Monitoring Boards. Currently, some agencies and organizations that provide funding opportunities for clinical researchers, require that grant applicants document that a pharmacist will be actively involved in the research process. This highlights that it is important that study teams have access to a drug information expert. This may be through the services of a pharmacist member of the research team, or through the institution’s staff pharmacists. It may also be through collaboration with external research pharmacists. It is expected that the role of pharmacists in clinical research will continue to expand, as new opportunities arise for them to collaborate with other researchers or to initiate research studies as principal investigators.