DATA AND LOGISTICS
general feasibility questionnaires to build up the sponsor’s internal knowledge repository on sites. With these surveys, sponsors ask key questions pertaining to the site’s IRB requirements, storage capabilities and equipment. Unlike study-specific surveys, these typically will have no close date and some sponsors will use a “reminder” functionality in the platform to ping sites quarterly or annually to review and update their profile information. The result of this is faster and more informed development of site lists when new protocols are formed. Sponsors also receive faster responses to trial feasibility surveys as sites can just focus on protocol- specific questions after confirming their pre-populated answers are still accurate. Another type of proactive survey some
teams leverage would be to share proposed protocol designs with key opinion leaders and sites ahead of protocol finalisation to solicit feedback. This can help identify potential obstacles within the patient eligibility requirements, supply chain complications and storage requirements that the sponsor may not have considered. Proactively taking their feedback into account helps avoid delays and amendments to the protocol during site selection or even once the trial is ongoing.
COVID-19, decentralised trials and e-feasibility Many users of data and e-feasibility questionnaires have been able to quickly pivot during the COVID-19 pandemic to account for new operational and supply complications. Over 1,000 industry sponsors announced disruptions to planned and ongoing trials as of July 2020, whether it was delayed initiation dates, slowed enrolment or completely suspended enrolment. Once the impact of the pandemic was clear, some sponsors immediately leveraged surveys to communicate with their sites regarding challenges for ongoing trials. They could determine which sites were slowing in enrolment and consider if virtual components might be feasible. As disrupted trials began to resume, some sponsors still adjusted their processes to use e-feasibility questionnaires to check on COVID-19 requirements at each facility. They included questions on whether trials could be performed at this time, the need for PPE supplies and other COVID-19 requirements that could impact timing of patient recruitment or trial execution.
40 | Clinical Trial Supply Handbook
Although decentralised trials have been a popular topic for years, the COVID-19 pandemic really accelerated this shift in the clinical trial landscape. Between the years 2017 and 2019, the number of new trials initiated with virtual components was growing at a rate of 11% per year. This increased to 20% growth in 2020 and 25% growth coming into 2021 (also note, this is based on data reported to date and 2021 trial initiations are still incoming). By using data like GlobalData’s Pharmaceutical Intelligence Center, clinical teams at sponsors and CROs can quickly identify sites with certain decentralised experience. For example, they could pull a list of over 2,600 clinical sites that have experience with home blood glucose monitoring devices being a part of a decentralised clinical trial. This type of intelligence can help study and supply teams focus their feasibility efforts and reduce risks of working with sites that haven’t needed to supply or use a virtual component foreign to their site.
Sponsors are more frequently asking sites about capabilities with regards to decentralised trial designs, remote site trainings and remote monitoring through feasibility questionnaires. Thus far in 2021, sponsors using SiteSurvey are asking six times more questions on remote trial components or virtual training compared to 2019. Including supply chain questions is especially important with decentralised trials. Sponsors can inquire about concerns with transportation and storage of the drug in patients’ homes or whether they offer home nursing services. Some sponsors have gone as far as to inquire about the possibility of a remote site qualification visit and the ability for the sponsor to remotely view key lab, processing and storage facilities. There are many data sources and technologies
involved in clinical trial feasibility and site selection and it is not always easy to map out the most effective work flow for various systems and teams to work together. There is a proven benefit to sponsors to explore disrupting the status quo and identifying data, technologies and synergies between feasibility and logistics teams during trial planning. If implemented correctly and early during the study planning process, the solution can save the sponsor valuable time and reduce risks of a delayed trial by optimising site selection.
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