SH3: Pharmacists’ involvement in clinical trials and ethical committees

 

Pharmacists traditionally have been involved in clinical trial research in a variety of ways, from providing drug and record-keeping for drug accountability, to taking on the roles from study coordinator to principal investigator.  The hospital pharmacist can play a fundamental role in the way clinical trials are conducted and contribute in different forms in the research process. The pharmacist can use his or her expertise and collaborate directly on pharmaceutical aspects such as drug composition and supervising indications, dosage, administration, contraindications, adverse effects and interactions of investigational drugs (IDs). Contribution during randomisation and blinding procedures are often required.

 

In addition, pharmacists can help to ensure the safety of human subjects and their rights, which are mainly protected by local ethical committees (ECs). For any of these functions, the pharmacist must be familiar with the research protocol, informed consent form, investigator’s brochure, and standard operational procedures of the hospital/ research centre, which include regulatory, ethical, and legal requirements.

 

Moreover, educating patients and monitoring therapy (including adverse drug reaction monitoring) are two clinical functions that are particularly important and applicable to investigational drugs. 

 

In addition, for non-industry sponsored trials, the professionalism of hospital pharmacists has been proposed for the task of clinical monitor.

 

After the presentation the participant should: