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“Clinical research helpdesk”: an active support for investigators in a large university hospital

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European Statement

Clinical Pharmacy Services

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.

Role of Hospital Pharmacist in the compassionate use of Risdiplam since the submission to Ethics Committee to the therapy in patients affected by Spinal Muscular Atrophy: an example of close collaboration with the neuromuscular team.

European Statement

Introductory Statements and Governance

Author(s)

Anna Esposito, Claudia Panico , Loretta Cervi, Emilio Albamonte, Alice Zanolini, Valeria Sansone

Why was it done?

This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.

What was done?

The hospital pharmacist (HP) supports the neuromuscular team (NT) in submitting the request to access compassionate use with Risdiplam in patients affected by spinal muscular atrophy (SMA). Risdiplam is an orally administered, survival motor neuron 2-directed RNA splicing modifer for the treatment of SMA.1 The HP is involved in Ethics Committee (EC) approval, is responsible for reconstituting and storage of oral solution and is also responsible of re-supply and pharmacovigilance surveillance. This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.

How was it done?

HP is involved from the initial phases of the compassionate use of the drug. The NT that screens and enrolls the patients in the compassionate use program with Risdiplam by submitting a formal request to the EC. The teams of the EC, which includes the HP, evaluates the appropriateness and inclusion criteria for each patient. Once the patient is considered eligible, and treatment is approved, the HP receives the drug from Pharma, provides quality control and assigns the drug for each patient. HP prepares the oral solution and stores the products at 2-8°C until dispensing. After the initial dispensation it is the HP’s responsibility to work closely with the NT in order to maintain treatment over time, ensuring the right timing for re-supply of the drugs and medical devices.

What has been achieved?

There are currently 30 patients on therapy and they are monitored to ensure re-supply and reporting of any adverse events. Home delivery procedure was implemented in agreement with EC in cases where outpatient dispensing was difficult, especially due to logistical difficulties caused by the Covid-19 pandemic, if clinical conditions were stable. In addition, a strong collaboration between the HP and NT was implemented in order to provide access to an increasing number of patients.

What next?

Risdiplam has recently been approved and the HP is involved in the procurement and maintenance of ongoing therapies and ensures supply to new patients. The drug is under negotiation and HP will be involved in contracting procedures based on the expected number of patients and definitive inclusion criteria to access the drug

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