Royal Decree 1090/2015 on clinical trials establishes that ethics committees in charge of reviewing clinical trials should include a hospital pharmacist. Far from being restricted to acting as an expert in medications, the functions of this committee member also comprise evaluating and following up on the trial. This means that hospital pharmacists must be acquainted with the methodology to be followed in clinical trials and with the ethical principles to be adhered to when conducting research.
According to the law on quality assurance and rational use of medicines, pharmacists are responsible for the management of investigational drugs. Moreover, best practice guidelines indicate that the traceability of such drugs is of the essence. For those reasons, the role of the pharmacist as a guarantor of the proper management of the medication samples used in clinical trials is absolutely crucial. All pharmacists, members or not of an ethics committee, must perform this supervisory function, either as a full-time occupation or as part of their daily routine.
More often than not, hospital pharmacists involved in clinical trials tend to share the same problems, needs and concerns irrespective of their place of work. This is the reason why the existence of a workgroup that brings together the efforts made by the profession, gathers different initiatives and develops common projects is of interest for all.