DATA MANAGEMENT TECHNOLOGY & It’s time for sponsors to
information we require within seconds. Because people asked ‘what if’, we now order food delivery, manage our finances and track our health online. Yet, the ‘what if’ moment for the clinical trials industry has been a bit slower. Still, there are good reasons for the industry to think differently, with new medicines becoming increasingly complex to develop and more difficult to gain approval to come to market. We founded Teckro in 2015 because we asked,
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‘Why can’t clinical trials be more simple, accessible and transparent?’ And we are now seeing more pharmaceutical and biotechnology companies adopt this mindset. In response to the pandemic, we have seen the urgent need to connect all stakeholders with study information when and where they need it, from any digital device. Armed at the point of care, research site staff can improve their decision-making and better follow protocol instructions, meaning safer, faster and more efficient clinical trials. While technology is not a silver bullet, it can help sponsors take a major leap forward to better manage time, resources and cost of clinical trials. What would this look like to a sponsor; fewer errors are made, trial data is more reliable, and new drugs and treatments come to market quicker. In the end, lives are saved and the quality of life is improved for patients. By adopting a forward-thinking approach, sponsors can improve their clinical trial operations with tangible, measurable results.
Improved protocol compliance Quite often, study protocols are stored via a PDF in an online portal or as paper documents on a shelf somewhere, much like the telephone directory of the past. The protocol also tends to be far away from the clinical area, where participants are seen. Recent
54 | Outsourcing in Clinical Trials Handbook
reakthroughs happen when we ask, ‘what if?’ In the digital era, we have gotten used to searching and retrieving almost any
rethink clinical trials Gary Hughes, CEO of clinical trials software platform Teckro, addresses how global pharmaceutical and emerging biotech companies can reduce costs, better manage risk and increase collaboration.
research published by the Tufts Centre for the Study of Drug Development (CSDD) in collaboration with Teckro showed that the majority of investigative site staff are still reliant on paper and desktop computers to reference protocol instructions, which inherently means answers are not instantaneous. Staff have to go to where the protocol is stored and then flip or scroll through pages to find the information. Then there is the concern of whether that version
of the protocol is the right one for that site. The Tufts- Teckro research data also revealed that the majority of respondents receive protocol amendments via email, which can easily be missed or not communicated to everyone involved in the trial. Considering how difficult it can be for research
staff to find answers from the current protocol, it is not surprising that non-compliance with the protocol is consistently a major finding of the FDA’s inspections. But what happens when the right version of the protocol is available for investigators, study coordinators, CRAs and others involved in the study? If the protocol is in your pocket on your smartphone, then the right answer is always just a couple of seconds away. For most of us, it is second nature to search for answers on our smartphones – why should clinical trial information be any different.
Accelerated patient enrolment Did you know nearly half of first-time investigators say they wouldn’t want to be involved in a second study? This is a big problem as physicians serve as trusted advisers, and can have influence in reaching underserved and underrepresented populations to encourage greater diversity and inclusion. Physicians have a short period of time to make critical decisions when they are with patients and need to be sure they are following the correct version of the protocol. This can be even harder for larger research centres if they are running several trials for different sponsors in the same disease area.
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