Clinical Insights firm Informaconnect recently questioned a variety of organisations working within the clinical research industry in a bid to identify some of the biggest challenges faced when conducting trials today. Perhaps unsurprisingly, up there at the very top of the list was clinical trial design, closely followed by regulation, patient access, and skilled staff.
The Tufts Center for the Study of Drug Development has found that the complexity of trial procedures, especially at phase III, is increasing. Today’s trials are demanding more time and effort than ever. And while we can’t deny that we’re bringing this on ourselves in a bid to achieve more and transform the medical world, it’s a move that’s making trials more vulnerable to failure, especially when we try to manage everything in-house.
The solution? Virtual CRO services which enable teams to delegate tasks to a supporting agency. A Virtual CRO service like Virtual Clinical is designed to offer a wide range of specialist services including project management, clinical operations, regulatory services, pharmacovigilance, medical affairs, data management and legal services.
It’s been reported that half of all clinical trials undertaken across the European Union fail to comply with EU regulations, and the risk with this is that even a seemingly successful trial can ultimately fail to bring a drug to market if it doesn’t adhere to the rules. Some reports cite the cost of compliance as a factor, but it’s more likely to be the ‘little things’; around 30% are marked as complete without a completion date, for example.
The solution? Ensure that you have the necessary resources in place for full compliance and pharmacovigilance throughout the duration of the trial. If you’re not 100% confident in the ability of your existing team, it’s well worth bringing on board a dedicated regulatory services provider, along with experts in legal and medical affairs.
Patient recruitment and retention is often discussed as a major obstacle standing in the way of successfully bringing drugs to market, but one of the biggest pitfalls of managing a clinical trial is actually accessing patients in the first place. It’s reported that 86% of clinical trials fail to recruit enough participants within the planned time frame, and that 19% of trials end early as a direct result of not being able to recruit enough people.
The solution? Consider conducting decentralized rather than centralized clinical trials. By working with a virtual CRO with the technologies and capabilities needed to manage and oversee projects remotely, the eligible patient pool becomes much larger. You’re no longer limited to only local patients… you can even recruit globally.
To say that there is a skills gap in the existing clinical research landscape is perhaps stating the obvious. And this is especially true at a time when pharma companies are expanding their research globally and are trying to navigate the common issue of identifying experienced research professionals abroad.
The solution? Gaining access to a pool of professional virtual clinical associates who work on a contract basis, as and when needed. CROs can provide project, data, and clinical managers, as well as medical monitors, research nurses, site coordinators, administrators, legal specialists, and programme directors, wherever you’re based.
Get in touch with us to find out more about how we can help.