Center for Clinical and Translational Science

The pharmaceutical process is divided into five categories: procurement, prescribing, dispensing, administering, and monitoring. These categories apply to all FDA approved drugs and assist to ensure the safe outcome of drug therapy. Most investigational drugs dispensed in hospital pharmacies are sponsored by pharmaceutical companies. The companies have formal policies about following the pharmaceutical process and pharmacists are usually responsible for adhering to them.   After the establishment of The Center for Clinical and Translational Science (CCTS), more investigator-initiated clinical studies are conducted and pharmacists therefore take a more active role in study development. This increase in clinical studies led to a number of enhancements in the services provided by the Rockefeller University Pharmacy.

The Clinical and Translational Research Facilitation Office in the CCTS (the Navigation office) provides researchers assistance with protocol development, continuing education, and study conduct through its Navigation program.  Any use of a drug product in a protocol receiving Navigation also receives consultation from the pharmacist focused on the five categories of the pharmaceutical process.

The pharmacy may be contacted in the very early stage of protocol development to provide input about the feasibility of transferring a “bench” chemical into a compound suitable for clinical use, to evaluate whether a subcutaneous formulation would be better than an intravenous, or oral formulation, or to help determine the proper dose. At this level, the pharmacist strives to gather information through literature searches to provide the best possible information at the navigation meeting.  Information may be limited, so the pharmacist often provides direction for the investigator on where to obtain further information.  If the investigator knows the name of the chemical, the pharmacist can determine if the chemical exists as a drug or if a clinical grade of the chemical is available.  The next step is to evaluate whether the chemical can be obtained from a wholesaler, if it needs to be imported from another country, and if we should compound it in our pharmacy or outsource compounding to another pharmacy.  After the chemical is obtained, the pharmacist determines if it needs to be sent for chemical and biological analysis to ensure it is suitable for clinical use.  Whereas compounding with a non-clinical grade chemical for a therapeutic use may be appropriate in the treatment or cure of a specific illness, the same compound would not be acceptable to administer to a healthy research volunteer or to a sick volunteer with options for alternative treatments. In those situations the pharmacist will require that the investigator apply for an Investigational New Drug (IND) exemption or ask the U.S. Food and Drug Administration (FDA) whether an IND is needed.  Once the chemical is obtained and has undergone testing, the next challenge is deciding how to formulate it into a suitable drug. The pharmacist will search the literature for articles describing the method for making a similar formulation.  Information from professional organizations and informal contacts with other research pharmacists also may provide very valuable information.  The specific formulation is developed once the preparation and dosing are determined. After the compound is formulated, it is sent to a certified lab for potency analysis to validate the compounding method.  If it is a sterile product, it will also require testing for sterility and pyrogens.

At Navigation meetings, the pharmacist can further assist in determining the subject inclusion and exclusion criteria by deciding if there are contraindications or drug-drug or drug-disease interactions that need to be considered in the specific study population.

By being part of the Navigation process the pharmacist can insure the incorporation of the proper pharmaceutically methods at the very beginning of the study, which leads to a better protocol design.  It also saves the investigator time by avoiding having to amend to the protocol at a later stage.  Thus, the pharmacist plays a vital role in efficiently and rapidly developing a scientific sound and safe protocol!