IN PARTNERSHIP
A way for sponsors to differentiate themselves and be the ‘sponsor of choice’ is to make it as easy as possible for research staff to conduct their trials. Paper and online portals are anything but easy for research staff. Considering that just under half of sites will either under-enrol or not enrol at all, it is in their best interest to find ways to better engage sites and help them to conduct the trials as simply as possible. What we hear is that research staff want to be confident in their decisions. The first step to enabling research staff is to give them the most current study information, when and where they need it. With immediate access to all relevant study information, they can view the exact inclusion or exclusion criteria to make the best-informed decisions about enrolment, procedures for a given visit, or how to assess a potential adverse event. Think of a virtual ‘coach’ who is always there for research staff every day, night or off-hours, for example. There’s also a potential to tap into a wealth of
information if sponsors track trends of research staff queries. Search activities can indicate what sites are engaged with the protocol. Recurring search phrases can give early indications into potential safety issues or the need to provide further information. Unblocking sites with information at their fingertips is a good way to attract physicians who might otherwise fall into the camp of ‘one and done’.
Real-time communication It would be ideal if every question could be answered simply by searching the study documents. The reality, however, is that there will always be some questions or clarifications that require the attention of study or medical experts. If we think about our own daily lives, there are many two-way channels to get quick confirmation and instant clarifications. We know the people on the other end can provide that answer and it will come back quickly if they are online. Why doesn’t this same principle apply to clinical trials, especially considering the complex and time- sensitive questions associated with research? Today, instead of connecting sites and experts,
we see that CRAs fall into the role of a switchboard, fielding queries that then need to be directed on to someone else. And there are so many channels – email, phone, text and chat – that it can be difficult to keep everything straight and ensure queries are fully resolved. Not to mention that there are inevitable time delays at each step. Like many business problems, effective communication is often the way to resolve issues. In
this case, real-time communication can help alleviate bottlenecks and time delays. With a dedicated channel to a dedicated group of experts, sites staff can simply use their smartphone to confirm a decision or get further clarification in an auditable, compliant exchange. Going a couple of steps further, imagine what could be possible if sponsors had a more direct line of communication with sites. For example, valuable, field-level intelligence can be gathered by sponsors to influence trial success and future study design. Additionally, targeted proactive communication by study teams can alert research staff and CRAs of important changes, updates, or essential guidance relevant to them. This approach removes the risk of important information, such as protocol amendments getting lost in an email inbox. A platform that provides self-service access to study information, delivers relevant, targeted updates and opens a secure channel for sites to get clarification or help from experts – now that really changes the game for sponsors to help their site staff and CRAs.
The Covid-19 effect During the pandemic, we have learnt the value of agility when it comes to keeping clinical trials running in spite of crisis situations. The spotlight has been on the pharmaceutical industry, with the world waiting for a vaccine or treatment for Covid-19. Clinical trials are now front and centre for millions of people who previously would have been unaware of clinical research. Your average citizen doesn’t necessarily appreciate the complexity surrounding clinical trials. They certainly wouldn’t understand studies being trusted to antiquated methods such as paper and desktop computers – especially when many people will be reading about the news from their digital devices. When there are periods of upheaval, huge
technological and social changes tend to occur in a short period of time. Momentum created out of necessity from Covid-19 is an opportunity to move the pharma industry into the 21st century. While change can be seen as risky, especially for an industry that is inherently risk-adverse, slipping back into antiquated approaches could pose greater risks to future drug development.
The genie is now out of the bottle and there is no going back. ●
www.teckro.com Outsourcing in Clinical Trials Handbook | 55
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