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Clinical trials
  1. Piera Polidori1,
  2. Despina Makridaki2,
  3. Stephanie Kohl3
  4. delegates of the 52nd EAHP General Assembly
  1. 1 Hospital Pharmacy Complex Operational Unit, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Palermo, Italy
  2. 2 Pharmacy Services, "Sismanoglio- Amalia Fleming", General Hospital of Attica, Athens, Greece
  3. 3 Policy & Advocacy, European Association of Hospital Pharmacists, Brussels, Belgium
  1. Correspondence to Stephanie Kohl, Policy & Advocacy, European Association of Hospital Pharmacists, Brussels, 1200, Belgium; Stephanie.Kohl{at}eahp.eu

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EAHP position paper on clinical trials

Meeting future healthcare challenges!

Clinical trials are essential for continuously improving patient outcomes and their quality of life. Medicines used in clinical trials need to be securely managed by trained personnel capable of directing their storage, dispensing, return and destruction. Hospital pharmacists are members of the multidisciplinary team needed for safely managing clinical trials. 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.

EAHP calls on national governments to recognise the important roles that hospital pharmacists play in clinical trials by requiring their involvement to increase patient safety.

EAHP encourages regulators to further improve training on clinical trials by anchoring it into both undergraduate education and continuing education of pharmacists.

EAHP recognises that not all patient groups are suitable candidates to be fully represented in clinical trials. Where appropriate, efforts should be made—taking into account also all relevant constraints—to create clinical trials that also study the effects of new treatment options in diverse patient populations, so that these groups can be provided with access to new medicines once approved.

EAHP underlines the importance of utilising the full potential of the EU Clinical Trial Regulation by swiftly putting all necessary measures in place at the national level to successfully transition to this new regime.

EAHP urges the …

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Footnotes

  • Collaborators Delegates of the 52nd EAHP General Assembly.

  • Contributors The position paper was approved and adopted by the delegates of the 52nd EAHP General Assembly in June 2022.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Commissioned; internally peer reviewed.