RESEARCH ORGANISATION IN INDIA

Role of pharmacy staff in clinical trials

International clinical trials day is held on 20th of May each year in commemoration of the first clinical trial conducted by James Lind on scurvy in 1747. It is used as an opportunity to highlight the importance of drug discovery and clinical research, as also to encourage patient and professional participation in research. One such group of professionals who play a vital role in clinical research is the pharmacists.

A pharmacist does not have to necessarily be a person dispensing drugs at a local pharmacy. Do you know pharmacists are important to clinical research? Wondering how they are involved in clinical trials? Read on to know more.

A pharmacist contributes to a clinical trial in many different ways, before, during or after a clinical study. The success of a trial is connected to the role assigned to the pharmacists as they are concerned with patient safety and investigational drug availability to patients. A pharmacist is the primary source who ensures that a correct drug in right doses is made available to the patient. They are also the first persons who report of any mistakes made by the patient in taking the provided drug dose, as well as any drug related side effects.

What other roles do pharmacists perform in a clinical trial?

Pharmacists are entrusted with several other roles that are a vital part of documentation. Any negligence in these steps could result in the trial being questioned during audits. The pharmacists have to:

- Ensure the drug receipt is always recorded in study documents.

- Dispense the investigational drug to appropriate patients in right doses.

- Verify, ensure and document:

· Packaging and labeling of the drug

· Drug composition

· Lot number

· Manufacturing and expiry dates

· Correct dosage and use

· Handling and storing conditions

· Administration routes to ensure the safe use of drug.

This is not all! A pharmacist has to make sure that the physical and qualitative aspects of the drug such as appearance of drug packs, color of the drug, are the same for each lot supplied. Any discrepancies noted must be immediately communicated to the sponsor.

Does this mean a pharmacist is just involved in drug dispensing?

No…absolutely not! As a pharmacist enters naïve into the clinical research industry, there is ample opportunity to grow to be a clinical research coordinator (CRC) and clinical research associate (CRA). Apart from patient care and patient management, pharmacists can grow to be directly involved in research projects, design early-stage clinical trials, and supervise the trial site for compliance with protocols and good clinical practices. They can also be a member of Institutional Review Board (IRB) for reviewing special research categories where expertise is not available. They have opportunities to grow to executive level management positions as well.

Although pharmacists currently form a minority group of professionals enrolled in clinical research, the trend is changing towards hiring trained professionals to ensure safe and faster research.

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