KCR experts are always on the lookout for top trends, but a new calendar year brings a lot of new opportunity. KCR thought leaders are surveying their sectors and weighing in on what they expect from the clinical research industry in 2023.
Quality Assurance: KCR Head of Quality Assurance and Compliance, Irena Lambridis
What will have the biggest impact on quality in clinical trials in 2023?
“Technology integration. Technology supports QA activities in the drug development space by helping to improve data management, quality control, risk management, monitorig and reporting, supply chain management and more. More recently, technology has supported better outcomes in Remote Interactive Evaluations (RIEs), activities carried out by the FDA to assess the regulatory compliance of a manufacturing facility and bioresearch monitoring facilities supporting clinical trials. RIEs are similar to on-site inspections, but they are performed remotely using technology like video conferencing.
Because RIEs are typically less time-consuming and less resource-intensive than traditional on-site inspections, they can be conducted more quickly and help speed up the drug development process. Proper management of technology like electronic data capture (EDC) and clinical trial management systems (CTMS) allow for this enhanced speed. Having tech expertise ensures data from the clinical trial is accurate, complete, and properly managed, which can make it easier for the FDA to review the data during the RIE.
Similarly, encryption, secure data transfer protocols, and secure data storage technology works to protect the data during the RIE, and leads to higher quality QA performances across the spectrum of clinical trial activities. By using technology to support RIEs, it’s possible to improve the efficiency, accuracy, and integrity of the RIE process and ultimately, clinical development.”
Regulatory: KCR Director of Regulatory Affairs, Torsten Staller
What challenges does the full implementation of CTIS present for clinical trials in the EU
“The evolution of regulations via the EU Clinical Trials Portal (CTIS) have the ability to provide opportunity by offering more transparency in Clinical Trials throughout the EU, but there are function problems to overcome before that is fully possible.
We have become aware that the reorganization of some national ethics committees in relation to the EU CTR is sometimes too slow, which they are trying to circumvent with provisional solutions. Ultimately, this affects the processing of submissions.
Additionally, CTIS asks for the provision of two document versions, one for publication and one not for publication, regardless of whether a deferral has been requested and approved.
The EU CTR transparency rule affects many study and site documents throughout the lifecycle of a study. The conscientious preparation of the different document versions is resource-intensive and must be managed efficiently by the applicant to maintain true transparency.”
Technology & Innovation: KCR Chief Technology Officer, Doug Bain
What do you anticipate being a hot topic in clinical tech this year?
“I expect to see three main things within the clinical trial technology field this year. I think the AI / ML hype will move quickly through a lifecycle of hype into reticence followed by longer-term demonstrable value from companies that are able to fully leverage it within existing business flows.
The Decentralized Clinical Trials hype will continue to steadily move to Hybrid trial realization with service companies (Digital CROs in particular) bridging the gap between promising technology and complete, scalable hybrid clinical trial solutions.
Investigator Sites will see improvements in the complex array of disconnected technologies across clinical trials with increasing take up of site optimized clinical trial platforms.”
Trial Execution: Head of Trial Execution, North America, Erin Phillips
What challenges will we see in clinical trial execution this year?
“Site staff availability post-covid continues to pose a challenge. We have seen heavy turnover at the site level, leading to site personnel taking on more work. This has led to delays in the site start up process and the number of studies a site can accept. This causes delays in the feasibility and site selection process.
In clinical monitoring, especially in the US, many sites still do not allow onsite visits. CRA’s have become accustomed to conducting remote visits, however, it does not allow for full visibility into all site activities. This year, ideally, sites will begin to allow a hybrid approach to monitoring (for example, every other visit is onsite) to allow CRAs to conduct tasks that can only be performed while onsite.”
