Swindon-headquartered healthcare group Wasdell has been playing its part in ensuring that clinical trials of a range of treatments have been able to continue safely throughout the pandemic.
The Covid-19 pandemic has meant that the interaction between patients taking part in clinical trials and health professionals delivering the investigational medicinal products has had to be reduced, in order to offer maximum protection against infection to both parties.
The Wasdell Group, which is one of Europe’s largest independent partners to the pharmaceutical and life sciences industries, has been working closely with sponsors of clinical trials and with the relevant authorities to develop new ways of delivering products directly to patients.
As each National Competent Authority issued updated guidance as a result of the pandemic, experts at Wasdell helped establish and refine a framework that would enable products undergoing trials to be delivered directly to patients (DtP) and directly from patients (DfP). This meant that patients could be treated at home, rather than being exposed unnecessarily to other patients in hospitals or other clinical settings.
This framework ensures the safe delivery of products, while complying with the standards required by the National Competent Authorities. The framework covers the clinical oversight of the administration of the medication, monitoring and reporting of adverse events, while protecting patients by limiting unnecessary social interactions.
The adoption of these new approaches has meant that, despite the coronavirus-related restrictions, existing studies were able to proceed and new studies have been able to commence. The DtP model allows the trial patients to continue to be recruited and provided with investigational medicinal products on time, direct to their homes, with clear information about how to administer and use the product.
Wasdell’s Quality Management System was used to successfully manage the DfP project, ensuring all risks were assessed at various stages during the returns process. The final solution included arranging collections with full tracking and traceability and returns of products for certified destruction.
Wasdell Group’s chief operating officer, Daniel Tedham, said the concept of administering products undergoing clinical trials directly to patients at home had long been an aspiration of the pharmaceuticals industry, but was believed by many to be unrealistic.
“The need to keep patients away from clinical settings as much as possible during the pandemic has accelerated the drive to devise DtP models,” said Tedham.
“Our work has not only helped keep patients safe at home, but has developed some highly effective strategies for successful clinical trials in the future. We have taken a highly personalised and patient-centric approach, which has not only improved the patient experience but also met the needs of the trial sponsors.
“It is said that necessity is the mother of invention and, in this case, that is true. The dilemma about whether to invite potentially vulnerable patients into settings where they were at higher risk of becoming infected with Covid-19 has led to creative but rigorous new approaches that bring long-term benefit to clinical trials and, ultimately, current and future patients themselves.”