Turn to our FSPx® to jump-start or re-start your clinical trial
The COVID-19 pandemic has had a profound effect on clinical development, with hundreds of clinical trials paused or delayed. Travel restrictions and the fear of potential exposure to the virus prevented many patients from making site visits, and the magnitude of the health crisis strained provider resources. Consequently, enrollment was paused on many trials, and many others have been stalled in the planning phase.
We don’t know how long the pandemic will upend normal life, nor how long it will be before clinical development resumes in full swing. It’s clear, though, that for the time being, sponsors and Contract Research Organizations (CROs) must contend with a backlog of trials and find innovative ways to reduce risks for patients. Thus, the trend of making trials more patient-centric, which was underway long before the pandemic, has accelerated, and decentralized trial designs are being widely adopted, reducing the number of site visits required of patients.
Coping with external data sources
That’s all to the good, but it does introduce new challenges for sponsors – in particular around data collection, aggregation, and management. In decentralized trials, data flows in rapidly from sources other than the Case Report Form (CRF), to include various types of labs (central, local, specialty) as well as patient-reported outcomes (PRO) instruments and wearable devices ranging from smartphones and smartwatches to patches and Holter monitors. An increasing number of vendors supply data in disparate formats, and all of it needs to be mapped to a standard, controlled for quality, and reconciled – all while maintaining the blind.
The Tufts eClinical Solutions Data Strategies and Transformation Study published in 2019 found, not surprisingly, that the increased volume and diversity of data sources being used in clinical trials is contributing to delays in trial completion. Since the last study completed in 2017, large pharmaceutical companies have reported a 32 percent increase in time from the Last Patient, Last Visit (LPLV) to Database Lock. Meanwhile, those that have implemented a formal data strategy have seen a six-day improvement from the LPLV to Database Lock, compared to companies with no formal strategy.
Recognizing the value of a data strategy especially as trials decentralize and need to make up for lost time, we’re offering a webinar, “Managing External Data Sources in Clinical Trials: Current and Future Strategies.” We’ll explain techniques for managing data from non-CRF sources and will offer advice on how to ensure data currency and accuracy and how to interface with more and more varied data sources. The webinar is open to registration now.
Preparing study submission deliverables
After you’ve overcome the hurdle of Database Lock, the real work for project managers, medical coders, statistical programmers, CDISC specialists, biostatisticians, and medical writers begins: preparing the data for eSubmission to regulators.
Most sponsors are familiar with the staffing services offered by Functional Service Providers (FSPs) (see below), but may not realize that the right FSP partner is capable of actually performing the work itselfthrough a deliverables-based FSP engagement. Partnership models run the gamut from [PHP1] hiring insourced, Full-Time Equivalent (FTE) employees to relying on embedded FTEs whose work is overseen by the FSP to the contracting for unit deliverables (specific deliverables) from the FSP.
One mid-sized pharma company chose to work with the FSPx® team to deliver the integrated summary of safety (ISS) and the integrated summary of efficiency (ISE), both integral to study submissions for New Drug Applications (NDAs). The challenge was to support data conversations across multiple study data tabulation methods (SDTMs) as well as perform validations and prepare reports for submission for 52 studies. Read about our approach, which incorporated approximately 3,500 deliverables from the 52 studies into unified, submission-ready summary documents.
Scaling up during the pandemic
The need to scale your workforce rapidly is challenging in the best of times, but it presents a Herculean task in the midst of the COVID-19 outbreak. One drug sponsor estimated that it would need at least a year to recruit, interview, and onboard 60 CRAs to support a study in Chinaif they did it themselves. Learn how the FSPx team stepped in to find qualified candidates ahead of schedule, even while working remotely during the pandemic.
At virtually every stage of the development process, resourcing can be tight as deadlines loom. And with timelines and work processes having been altered by the pandemic, the crunch can be even greater. FSP partners such as our FSPx can be a solution to meeting your business demands, whether by helping you staff up quickly, or by stepping in with our expertise to actually complete assignments.
 De Martini, A., Lockhead, D., Plappert, L., Rountree, E., “The impact of COVID-19 on clinical trials,” PMLive, June 30, 2020.
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