Author(s)

C González-Pérez, E Tejedor Tejada, F Capdevila, C Martínez Nieto, A Ferrer Artola, G Lizeaga Cundín, JA Domínguez Cháfer, A Martín Uranga, V Morales, M Serrano Alonso.

Why was it done?

Spain aims to reinforce its position as a leading country in clinical research at the European and global level. Hospital pharmacists are essential to ensuring the safe and efficient management of IMPs, yet their role is often under-recognized or inconsistently defined.
The increasing complexity of clinical trials—driven by digitalization, decentralization, and environmental demands—requires updated, standardized guidance to support excellence, regulatory compliance, and equitable access.

What was done?

A multidisciplinary working group, including representatives from the pharmaceutical industry (Farmaindustria), hospital pharmacists from the Spanish Society of Hospital Pharmacy’s (SEFH) Clinical Trials Group, and the General Council of Official Colleges of Pharmacists, revised the 2022 edition of the Excellence Guide for the Conduct of Clinical Trials in Hospital Pharmacy.
The updated guide focuses on:
Clear definitions of pharmacy and sponsor responsibilities across trial phases.
Practical recommendations for investigational medicinal products (IMP) handling, labelling, donations, traceability, and medicine shortages.
Integration of digital tools and electronic documentation systems.
Sustainability practices aligned with European standards.
Strategic recommendations for decentralized trials and remote patient access.

How was it done?

The guide was developed through consensus among stakeholders, combining regulatory expertise, clinical experience, and operational insights. Contributions were based on real-world practices and aligned with current European legislation.

What has been achieved?

The updated Guide to Excellence in Clinical Trials in Hospital Pharmacy was developed and launched in Barcelona on September 30, 2025. The new edition offers a comprehensive framework to support hospital pharmacists throughout all phases of clinical trials, while also serving as a reference for sponsors and Contract Research Organizations (CROs) regarding hospital pharmacy department procedures.
Additionally, it includes annexes with practical infographics covering key areas such as a welcome manual model for sponsors, IMP accountability, site initiation preparation, remote monitoring, hazardous drug disposal, and non-sponsored medication management. These resources aim to facilitate implementation and harmonize practices across institutions.

What next?

The guide will be disseminated through professional networks, social media, specialized journals, and mailing lists targeting hospital pharmacists, CROs, pharmaceutical sponsors, and universities offering specialised training for clinical trial monitors.
A national survey will be launched to assess the reach and impact of the new edition and to identify challenges and improvement areas for future updates.

Author(s)

Irene Márquez-Gómez, Vicente Escudero-Vilaplana, Fernando Bustelo Paz, José Luis Revuelta Herrero, Roberto Collado-Borrell, Laura Maldonado Yagüe, Alberto Ruiz López-Alvarado, Ana Herranz Alonso, Juana Benedí González, María Sanjurjo Sáez

Why was it done?

Patient experience has been recognized as a critical determinant of healthcare quality, directly influencing adherence, safety, and clinical outcomes. In clinical trials, where investigational drugs and complex protocols often create uncertainty and stress, patients face unique challenges. Enhancing their experience is critical to ensure safety, and engagement throughout the trial. This project aimed to mitigate these vulnerabilities and to foster a more humanized and supportive care environment.

What was done?

A patient-centered model was developed to incorporate patient experience into the pharmaceutical care of clinical trial patients. The initiative sought to redesign care processes within the Pharmacy Department to better address patients’ expectations, needs, and vulnerabilities.

How was it done?

The project followed four phases: (1) Current workflows were mapped to detect bottlenecks in pharmaceutical care (2) Semi-structured interviews with trial participants explored their perceptions, concerns, and unmet needs; thematic analysis was applied to identify key insights. (3) The SAFARI observational method was used to document real-world interactions and organizational dynamics in the drug dispensation area. (4) A Patient Journey Map was created to visualize the care pathway and highlight critical touchpoints requiring improvement.

What has been achieved?

Analysis revealed several unmet needs: insufficient practical information on trial medication, limited visibility of pharmacy as a clinical resource, logistical barriers such as poor signage and physical distance from clinics, and confusion about dispensing procedures. Patients valued close monitoring by the research team but expressed interest in receiving additional pharmaceutical support. Overall, the hospital pharmacy was perceived primarily as a logistical space rather than a clinical partner, underscoring the need to reposition its role within clinical trial care.

What next?

Two key strategies have been defined. First, the establishment of a dedicated pharmaceutical care consultation for trial participants, focusing on critical milestones (pre-screening, treatment initiation, therapy changes), providing structured explanations, written reference materials, and systematic review of interactions and adverse effects. Second, the functional planning of a new Clinical Trials Unit, with improved physical spaces, closer proximity to the research team, and simplified patient circuits. These interventions aim to transform the pharmacy service into a patient-centered and supportive environment, and future evaluation will measure their impact on safety, adherence, and patient-reported outcomes.

Author(s)

Laura Maldonado Yagüe, Claudia Ramos Álvarez, Ana Herranz Alonso, Fernando Bustelo Paz, Eva González-Haba Peña, María Sanjurjo Saez

Why was it done?

Patient recruitment is still nowadays one of the barriers that the clinical investigation encounters: almost 80% of the clinical trials experiment delays and around 30% close due to the difficulties to identify candidates. Currently, the recruitment process in many of the hospital sites is based on the manual review of electronic medical records (EMR), which results in higher workload and higher errors and omissions. This tool aims to reduce manual screening time by 50% and increase recruitment by 20% always ensuring regulatory compliance (ICH-GCP, RGPD and national biomedical investigation laws).

What was done?

The Pharmacy Department led the initiative to evaluate TrialGPT, an Artificial Intelligence (AI) system designed to optimize clinical trials patient recruitment, in the hospital setting. Natural Language Processing (NLP) and Large Language Model (LLM) are advanced techniques used by TrialGPT which enables the automatic detection of potential eligible patients through their Electronic Medical Records (EMR) matching their profile to the inclusion and exclusion criteria for each clinical trial.

How was it done?

The project was coordinated by a Clinical Trials Unit of a tertiary hospital with multidisciplinary collaboration between pharmacist, investigators and IT specialists. Anonymized data of 50 active clinical trials from oncology, neurology and rare diseases areas were used. Technical challenges such as data heterogeneity, algorithmic bias and staff acceptance were encountered, in order to address these, an iterative training model, multidisciplinary workshops and ethical evaluation were used.

What has been achieved?

Preliminary simulations indicate that TrialGPT is able to reduce half the necessary time for patients screening and improve recruitment efficiency without compromising data security or clinical precision. The model achieved high sensitivity and specificity identifying eligible patients, demonstrating a high potential to optimize hospital investigation flowcharts.

What next?

A validation phase will evaluate the real-world performance and scalability in multiple sites. This initiative exemplifies an innovative digitalization and automatization of a process which could be transferred as a model for European hospitals in order to improve patient access to clinical trials, thus, advanced therapies.

Author(s)

I. GUMIEL BAENA1, L. ARMENDARIZ PATIER1, P. RIOS ESTEBAN1, R. VIZCAYA CORTÉS1, S. SANTOS MUÑOZ1, R. SANABRIAS FERNANDEZ DE SEVILLA1, A. SANCHEZ GUERRERO

Why was it done?

Efficient management of clinical trial start-up is essential to ensure timely initiation and compliance with regulatory and operational requirements. Hospital pharmacy services play a central role in handling, preparation, and accountability of investigational medicinal products (IMPs). However, information provided by sponsors is often incomplete or inconsistent, leading to delays, miscommunication, and additional workload at trial initiation. To address these challenges, a standardized approach was needed to collect pharmacy-related requirements proactively and optimize communication with sponsors.

What was done?

A standardized electronic form was developed to collect critical information from sponsors prior to the initiation of a clinical trial. The objective was to anticipate logistical, technical, and operational needs of the pharmacy service and to improve coordination during the start-up phase.

How was it done?

An electronic form (Jotform®) was created and sent to sponsors before the initiation visit. It included the following sections: (1) general study data (title, phase, code, investigator, department, duration, and enrollment); (2) investigational and auxiliary medication (description, dosing, and supply details); (3) logistical requirements (storage, shipping, and custody); (4) preparation and dispensing (procedures, need for pharmacy compounding, and prescribing system details); (5) returns and expiry management; and (6) additional pharmacy tasks (e.g., completion of sponsor platforms). The form was completed electronically and returned before pharmacy service approval.

What has been achieved?

Implementation of the form improved communication with sponsors, ensured early identification of specific requirements (such as special storage conditions or sample conservation), and clarified responsibilities regarding delegated pharmacy tasks. The process allowed more efficient planning and reduced start-up delays associated with missing or inconsistent information.

What next?

The standardized form will be regularly updated based on user feedback and extended to additional hospital departments involved in clinical research. This experience demonstrates a replicable strategy that can be implemented in other hospitals to enhance efficiency and quality in clinical trial management.

Pdf

Author(s)

Mafalda Cavalheiro 1
Joana Simões 1
Carolina Marques 1
Patrícia Batalha Silva 1
Miriam Capoulas 1
Cláudia Santos 1
1 – Pharmacy Department, Hospital da Luz Lisboa, Portugal

Why was it done?

Due to the connection with the clinical area and innovation, trials in our pharmacy services were previously assigned to each pharmacist specialized in the corresponding therapeutic area. In the beginning of 2024, the increasing number of clinical trials, coordination and investigational drug management challenges emerged and proved that the previous model was inefficient. Our aim is to develop a centralized unit that is the key to coordinate pharmaceutical activity and improve patient care in clinical trials. In addition to dispensing process, pharmacists become responsible for ensuring therapeutic reconciliation, patient education and treatment adherence, improving medication safety.

What was done?

During a time of continued growth in clinical trials number, it was defined as a pharmacy services’ goal the creation of a centralized clinical trial unit. Additionally, the need to structure a pharmaceutical consultation has arisen.

How was it done?

The process unfolded in three phases: team structuring, logistical reorganization and consolidation of the pharmaceutical care process. A lead pharmacist was appointed as coordinator, supported by a backup and three pharmacists in oncology and three in non-oncology. The major limitation was the establishment of the pharmaceutical team and their training for the several ongoing trials. The unit was reorganized into a larger area, including workstations, medication storage and a meeting room. The pharmaceutical consultation was structured into an initial evaluation and follow-ups. During the first consultation, the pharmacist conducts patient assessments, medication education, toxicity management information and drug/herbal interactions checking. Follow-up consultations focused on medication dispensing, compliance, adverse effects and patient concerns.

What has been achieved?

The centralized unit currently manages 66 clinical trials (37 oncologic; 29 non-oncologic). Seven oncologic trials regularly include pharmaceutical consultations, representing an average of 10 appointments per month. Given the benefits of pharmaceutical intervention, particularly in terms of increased adherence, reports of drug safety and compliance, the importance of this centralization is clear.

What next?

Due to logistical challenges, pharmaceutical consultations have only been implemented for oncologic oral medications. With the robustness of the centralized unit, the next goal is to expand pharmaceutical consultations to oral non-oncologic trials, following the successful model used for oncologic trials.

Pdf

Author(s)

Giulia CANCELLIERI, Piera POLIDORI

Why was it done?

Hospital pharmacist provides all management of investigational medical product(IMP), i.e. its conservation, distribution, return and destruction. However, each clinical trial involves different methods of managing the drug: this can mislead the pharmacist who has to manage multiple trials at the same time. With the aim of minimizing errors that may arise from the simultaneous management of different clinical trials, we have developed a method to classify clinical protocols by “risk index”.

What was done?

With the aim of minimizing errors resulting from management of clinical trials in hospital pharmacy, we have developed a method to classify experimental protocols into low-moderate-high risk(risk index). For each of these categories, standard procedures were then outlined in order to minimize the occurrence of any errors.

How was it done?

In order to determine risk index(ρ) we have identified all risks related to IMP’s management: pharmacological risk(φ), dependent on pharmacological characteristics of IMP; technological risk(α), if drug should be compounding; risk related to number of patients enrolled(np); risk inherent to the protocol(π), i.e. whether protocol involves placebo, or randomization, etc. These risks were then related through the formula created by us, ρ=φ+(α*np)+π: protocols are defined low-risk if ρ<50, moderate-risk if 51<ρ151. For each risk index, standard procedures were outlined in order to minimize risks, i.e.(for high-risk) inclusion of at least four pharmacists in “Delegation of Responsibilities Log”; scheduling monthly meetings with trial’s Monitor; dispensing of IMP with supervision by at least two pharmacists; etc.

What has been achieved?

We applied this method to 45 active trials in our hospital. For 3/45(6,7%) protocols, φ>75 because IMPs are carcinogenic; instead, 26/45(57,8%) protocols, involve IMP’s compounding; finally 29/45(64,4%) protocols are randomized and 14/29(48,3%) of these involve use of placebo. By applying aforementioned formula, we found that 3/45(6,7%) protocols are low-risk, 32/45(71,1%) moderate-risk, 10/45(22,2%) high-risk. For these 10, standard procedures were applied, to improve the safety of patients enrolled in a clinical trial.

What next?

We promote use of this method in other clinical centers, because we believe it can be a valid tool for risk minimization. Finally, we hope that we will receive numerous feedback from these centers to further improve the proposed method.

Pdf

Author(s)

Roberto Brunoro, Mariassunta Miscio, Girolama Iadicicco, Lorenzo Codato, Domenica Condello, Elisa Danieli, Viola Donadello, Alice Osto, Federica Pace, Giulia Valente, Francesca Venturini

Why was it done?

In our Italian University Hospital, we established the “Clinical Research Helpdesk” managed by the Clinical Research Unit. According to a daily schedule all personnel with an active role in clinical research can reserve an appointment with a pharmacist and administrative staff to ask questions for the submission of the necessary documentation for the Ethics Committee (EC) and for the evaluation of the study feasibility.

What was done?

In our Italian University Hospital, we established the “Clinical Research Helpdesk” managed by the Clinical Research Unit. According to a daily schedule all personnel with an active role in clinical research can reserve an appointment with a pharmacist and administrative staff to ask question for the submission of the necessary documentation for the Ethics Committee (EC) and for the evaluation of the study feasibility

How was it done?

The schedule is a Google Calendar tool which permits to generate slots of appointments. Researchers can access it by a link spread during a presentation event of the initiative. At each appointment the presence of a pharmacist for scientific counselling and a member of the EC scientific secretariat is guaranteed.

What has been achieved?

Since March 2022 the helpdesk accounts for 120 appointments with an average of 17 appointments/month. Typical questions are related to documental forms clinical trials rules and regulation counselling; in the last period support was requested also for practical issues, e.g., CE marking for investigational medical devices, feasibility evaluation, contract agreement and informed consent. After the helpdesk activation, the processing time for all the evaluation steps from the document presentation until EC submission, decreased by 50% compared to the previous year. The service increased study submission: the requests for evaluation of interventional studies received by the helpdesk increased by 15%, whilst for observational studies the percentage increase was 10%.

What next?

We are planning to expand this service to reach a complete management of clinical trials introducing a “RedCap team”, consisting of clinical pharmacists and biostatisticians who will help researchers in study design, Clinical Research Forms (CRFs) creation, statistical evaluation and data interpretation. A legal team for legal issues and contract agreement counselling will also be offered. The aim is to increase the visibility of our hospital, making it more attractive for clinical research.

Pdf

Author(s)

Kirsten Lykke Vorbeck, Laila Rabbani, Somia Mohammad, Anne Bøiehøj, Lene Sehested, Majken Cardel, Lone Skovhauge, Lisbet Emmery Jørgensen

Why was it done?

Having different sponsors with individual requirements and interpretations of rules, means a lot of work. The brochure aims to save time on answering questions by describing to every sponsor how Danish Hospital Pharmacies proceed. By demonstrating that we all do many things in the same way and ultimately have the same requirements, we hope to be able to encourage sponsors to adopt a more unified or aligned approach.

What was done?

Through a collaboration of Danish hospital pharmacies, a working group on clinical trials meet regularly to discuss general procedures and challenges to our handling of clinical trials. Via this a common presentation of how we handle clinical trials and what we can offer has been described in a brochure that is given out to sponsors, investigators, clinical trial units (CTUs), clinical wards, monitors etc. The brochure also serves as an inspiration catalogue to hospital pharmacy colleagues.

How was it done?

In the working group we have discussed processes and which administrative and quality requirements we find reasonable and called for (from our point of view and that of our sponsors). We appreciate that we cannot do everything in exactly the same way, but we have tried to include as much as possible in the brochure leaving it up to the individual pharmacy to supplement with local procedures.

What has been achieved?

The brochure is evidence of our cooperation within Denmark. It has been distributed to relevant partners and to “Trial Nation”, a national entry point for companies who wish to conduct clinical trials in Denmark. It is intended as general information and to be handed out to new potential sponsors. It has resulted in an aligned and time-saving procedure.

What next?

Hospital pharmacies are small players in the field of clinical trials but nonetheless important ones. Working together to find general procedures not only helps ourselves to identify good practices but also means we can create a smoother handling of the trials and that we stand stronger when meeting the different requirements from sponsors. This cooperative approach has met with a good response. It promotes further cooperation between all parties, and it is recommended to be implemented in other healthcare settings.

Pdf

Author(s)

Diane Le

Why was it done?

When the case for a study sponsored by the hospital has been filed a few months ago, the national agency authorizing trials raised the issue of health waltch, particularly the management of drug recalls. With the research department, which alerted us on the lack of resources for health alerts, and at the same time facing an international cease of some drugs, we set up a health alert and a regulatory watch system, to improve the quality of product and the patient’s safety.

What was done?

We set up a daily health and regulatory watch to stay abreast of any news. Regarding health watch, we included : studies for which the hospital is the sponsor ; studies for which the experimental treatments are not provided by the sponsor ; treatments used for adverse events and authorized by the sponsor.

How was it done?

Daily regulatory watch is carried out on the national legislation website with daily updates of national texts. If a new rule applies, it is written in a table to alert everyone.
Daily health watch is also carried out on the site of the national agency of drugs. Four types of information are recorded: drug shortages, alerts, recalls and releases.

What has been achieved?

Tables collecting those information are available on the pharmacy’s network so that anyone can read them, and can be shared with clinical research officers. To that day, some information has been collected due to a european legislation update on the clinical trials and has allowed us to anticipate what will change next year. We have not yet faced a drug recall but what has been done will allow us to react in the best way when this will happen.

What next?

The aim for carrying out regulatory and health watch is to allow us to quickly react and anticipate future problems, while keeping in mind the patient’s safety and the pharmacy practices improvement. This work was therefore completed with success, demonstrating the ability to react and the desire to deploy continuous improvement initiatives to strive for operational excellence and pharmaceutical. We now want to implement this work in the daily activity and extend it to other sectors.

Author(s)

Lorena Garcia Basas, Pablo Latorre Garcia, Eugenia Serramontmany Morante, Patricia Garcia Ortega, Pilar Rovira Torres, Laura Maños Pujol, Isabel Cidoncha Muñoz, Maria Queralt Gorgas Torner

Why was it done?

Increasing number of CT with IT, in different pathologies, with different tumor locations, contributes an increase in the complexity of drug compounding and procedures. Their preparation, administration and handling requirements differ from current therapies.

What was done?

Identification of critical points concerning intratumoral treatments (IT) preparation in patients with cancer included in clinical trials (CT).

How was it done?

Ongoing CT with IT in our unit were reviewed to identify critical points regarding prescription and preparation process. 14 trials with IT, 8 (57%) of which have ongoing patients were identified. Two of these trials are “first in human”. The critical points were:

• Nature of the IT: virus (4, 29%), nanoparticles (3, 21%), ribonucleic acid (2, 14%), cyclic dinucleotides (2, 14%), monosaccharides (1, 7%), phospholipids (1, 7%) and proteins (1,7%).Particularly, virus have special safety measures and transport conditions
• Dosing units: mcg (4, 29%), plaque-forming unit/mL (PFU/mL)(3, 21%), mL (3, 21%), mg (2 14%), ng (1, 7%), 50% Tissue Culture Infectious Dose (TCID50)(1, 7%).
•  Prior dilution before filling the syringe: 8 (57%) of our preparations require at least one prior dilution.
•  Drug volume to prepare according to the tumor size: 8 (57%) IT preparations depend on the tumor size.
•  Depending on the depth of the target tumor lesion (visceral or superficial), different size of needle is required. This is important because different priming volumes of the needles are necessary.

What has been achieved?

The whole information necessary for a complete prescription, validation and correct preparation goes further than information usually needed for current therapies such as chemotherapy. The results of the study of the critical points allow us to elaborate the standardized operational procedures (SOP) for each CT and IT.  These SOPs include the necessary information for a correct preparation for each IT, reducing risk of mistakes and achieving uniformity in the process.

What next?

These types of therapies represent a challenge, and pharmacists have an important role in developing new procedures. Communication between radiology, oncology and pharmacy departments in a multidisciplinary teamwork is essential. This information may be useful to other centers due to the lack of experience and SOPs to work with this type of therapy.