Clinical trials

• Published in: European journal of hospital pharmacy. Science and practice Vol. 31; no. 2; pp. 162 - 164
• Main Authors: Polidori, Piera, Makridaki, Despina, Kohl, Stephanie
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 01.03.2024; BMJ Publishing Group LTD
• Subjects: Access to information; Clinical Trial; Clinical trials; Continuing education; Drug interactions; Drug stores; EAHP position paper; EDUCATION, PHARMACY; Good Manufacturing Practice; Hospitals; Information systems; Medical personnel; Multidisciplinary teams; Occupational safety; Older people; Patient safety; Pediatrics; Pharmaceuticals; Pharmacists; PHARMACY SERVICE, HOSPITAL; Professional ethics; PUBLIC HEALTH; Regulation; Safety; Toxicity; Europe; PUBLIC HEALTH; Safety; Clinical Trial; EDUCATION, PHARMACY; PHARMACY SERVICE, HOSPITAL
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2022-003471

Within the European Union (EU), clinical trials are governed by the Clinical Trials Regulation, which harmonises the processes for assessment and supervision.1 This piece of legislation which entered into application in January 2022 also made the process for multinational trials more efficient owing to the single online platform known as the Clinical Trials Information System.2 The European Association of Hospital Pharmacists (EAHP) outlines in this position paper the role of the hospital pharmacists in clinical trials, provides information on the need to involve different patient groups, reflects on the improvements in Europe’s clinical trial landscape and discusses the role of ethics committees in clinical trials. Specific rules, precautions and practical specificities that apply for some of these medicinal products, such as exemptions from authorisation and GMP requirements for diagnostic radiopharmaceuticals, environmental safeguards for genetically modified ATMPs or specific rules for labelling need to be further considered in the training of hospital pharmacists and other professionals involved in clinical trials.10 To best carry out their functions as members of the multidisciplinary clinical trial team, pharmacists must be competent with the GCP guidelines, research protocol, informed consent form, investigator’s brochure and standard operating procedures of the research centre which include regulatory, ethical and legal requirements.4 To ensure that the aims of the Clinical Trial Regulation (including the promotion of higher standards in patient safety and increasing transparency in clinical trials) are met, education and training specifically targeted to clinical trials is essential for ensuring that each member of the team, including the pharmacist, can optimally contribute to the success of a clinical trial.11 This training should also focus on the preparation/compounding of high-risk and hazardous medicines, medicines with unknown toxicity/occupational safety profiles and medicines of a particular nature, such as radiopharmaceuticals and ATMPs. [...]improving the European clinical trial landscape The new EU Clinical Trial Regulation is based on three fundamental pillars: harmonisation of the procedures for carrying out clinical trials via the submission of a single e-dossier through a new information system, public disclosure of information obtained from clinical trials to increase trust and reliability and simplified safety reporting requirements.20 Through the introduction of the single European electronic portal for submitting trials, the EU seeks to accelerate the application process by simplifying and harmonising the administrative requirements for multicentre clinical trials.21 Also, access to information will improve thanks to the publication of a non-technical, plain-language summary of clinical trial results.22 To majorly change Europe’s role in the global clinical trial landscape, efforts need to be made throughout the transition period, lasting until January 2025. [...]EAHP underlines the importance of utilising the full potential