We spoke to dozens of the leading experts working in clinical trials and asked them what the one thing they would change about the industry would be if they had the power. Here are some of their answers.
Simplification of regulations
An unsurprising one to start with, the complexity of regulations is a complaint bound to be heard at every conference. As Julianne Hull, CEO of WenStar Enterprises, explains, she would like the “Streamlining, simplification and clarity of new and ongoing regulations.” Wenke Schult, MD emovis home care visits GmbH, puts it even more simply: “Reduction of red tape”.
Working more closely with legislators
Alongside the simplification of regulations, a common hope was to work more closely with those setting the rules, especially from an early stage in the process; “That Governments and Legislators worked with and invested in the industry from the outset”, as Mike Sitton, Consultant & former CEO at Haoma Medica, explains.
A sharing culture
Following moves by the FDA and EMA, data sharing is a hot issue in clinical research at the moment. The debate between a more open environment and one more of secrecy was reflected in our discussions, but there were certainly many who shared Managing Partner at Widler & Schiemann AG Beat Widler’s hope for “introducing a culture of sharing of compliance & quality information”.
One possible outcome from a more sharing culture, and something that came up repeatedly, was better standardisation across the industry. Helena Sigal, Founder of SIGAL SMS, highlights the need for “standardisation of processes between different sponsors/CROs regarding the site start up, qualification and trainings”. She points out that this has been started with the TransCelerate initiative but there is still a long way to go.
And international standardisation
As well as site standardisation, David Shalhevet, Associate Director and Senior Clinical Trial Manager at Teva Pharmaceutical, hopes to “Do away with the practice in which certain countries refuse study designs that involve a certain degree of patient risk, but approve treatment use based on research done in other countries.” Diane Driver, Head Outsourcing Contracts & Strategic Partnerships at UCB, goes one step further, aiming for “True Global Harmonisation – for submissions and approvals!”
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