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Clinical trials - role of the pharmacist

Questionnaire can be found in this link:https://de.surveymonkey.com/s/TW3ZHWD

Over the last two decades there has been a significant increase in the number of clinical trials worldwide. For higher quality of trial and consequently broader impact, it is necessary to have multidisciplinary approach in design, coordination and analysis of a trial. Members of team include principal and sub-investigators, clinical research coordinators (CRC), research pharmacists, and clinical research associates (CRA) among the others. Pharmacist is the most suitable team member for taking care of pharmaceutical aspects of investigated drug (ID) such as drug composition and for supervising pharmacotherapy (dosage, administration, contraindications, adverse effects and interactions of ID). Also pharmacist can help to ensure the safety and rights of human subjects and act as reference person for any protocol inquiries.

Nowadays, pharmacist are involved in clinical trials even before protocol implementation. They review medication management system throughout the protocol in accordance with joint commission standards (from prescribing to medication administration, patient education and monitoring).Also pharmacist responsibility is to ensure that all trial documentationand material meet the requirements of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

Eda Gedikoğlu with her pharmacy technicians team.

The increasing number of clinical trials highlight that more trained personnel will be required and that pharmaceutical companies and research centres will need to implement and train pharmacist for their role in clinical trials to a greater extent.

Because of the reasons mentioned above it is very important that pharmacist are involved in the research protocol and other aspects of a trial. Unfortunately in many countries, pharmacist are not fully integrated into the clinical research. In some cases, it only occurs when the study sponsor is compelled by legislation to require the presence of a trained pharmacist. To determine involvement of the pharmacist in clinical trials, small questionnaire has been designed by Eda Gedikoğlu a pharmacist from Baskent University Adana Research and Practice Center and  Turkey ESOP delegate (Picture 1.).

The aim of this questionnaire is to compare clinical trial standards in European countries and get more information about the implementation status of the Quapos 5. Also in the light of the information that will be obtained, it could be useful to have more information about the reliability of clinical trials.

Marko Skelin

Chair Public Relations Project

Questionnaire can be found in this link:https://de.surveymonkey.com/s/TW3ZHWD