Current Environment:

The Investigational Drug Service (IDS) exists as a satellite area of the Department of Pharmacy. The IDS functions independently and in conjunction with the other Pharmacy operations based on the specific clinical trial. It manages more than 300 drug studies at any given time. The types of trials include industry-sponsored, investigator-initiated, federally funded, or foundation-funded clinical trials.

The IDS team provides support and guidance for the safe and efficient conduct of clinical drug trials. Staffed by research pharmacists and technicians who are specially trained in the research process, they ensure the delivery of high-quality pharmaceutical care by adhering to federal and state regulations, accreditation standards, and institutional policies for investigational drug control.

In addition to dispensing duties, IDS staff work with investigators in designing trials, formulating budgets, developing templates for computerized prescriber order entry, and meeting with monitors throughout the lifespan of the trial. Patient safety is always paramount. IDS staff will also work closely with the study teams to prepare for any FDA audits and be present when the actual inspection occurs.

Education of all members of the research team is another function of IDS. Working with members of Institutional Centers for Clinical and Translational Research (ICCTR), a variety of educational programs have been develop to help first-time investigators, ranging from what an expanded access program is to how to prepare for an FDA site visit.

The IDS maintains independent storage facilities, including refrigerator, freezer, and deep freezer. Dispensing facilities for the clinical research pharmacy allow for the preparation of injectable, oral, topical, and rectal pharmaceuticals as well the extemporaneous compounding of agents from active pharmaceutical ingredients.

The IDS team has extensive experience in handling a variety of gene therapy protocols currently undergoing clinical trial. This rapidly growing area of research utilizes viral vectors such as adeno-associated virus or a lentivirus vector, or may use a vehicle meant to carry gene-editing elements consisting of messenger RNA, guide RNA, or protein. Given Boston Children’s Hospital’s strong commitment to research, the IDS team has been closely involved in several “N-of-1” studies involving a splice-modulating antisense oligonucleotide drug tailored to a particular patient. In these studies, genome sequencing is used to diagnosis rare diseases, followed by the design, testing, and manufacture of specific therapy derived from the cell lines from the patients themselves.

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