As clinical trials become larger and more complex, it’s essential that the many players dispersed across different sites and countries can work effectively as a team. Successful teamwork involves much more than healthcare professionals complying with the protocol or study managers running and monitoring the trial. An essential part of the clinical trial ecosystem is the patients – when they genuinely feel they are a part of it, they are more likely to attend visits, stay in the study, and endeavour to follow the protocol.
One significant hurdle to creating this sense of team is the fact that many of the people involved in a trial still work in silos and use separate operational procedures in distinct systems. Often, these are old, single-function, legacy systems that cannot be used together, and which present a number of challenges.
For example, study teams need to quickly onboard new sites, recruit new site staff members, and ensure everyone is trained and well equipped to run the study. Site staff, often juggling multiple studies at a time, need to identify and recruit eligible patients and take them through the ever-increasing list of study procedures. And patients, faced with pages of ICF information to read, often do not fully understand what they are signing up for and what will be expected of them.
Teams trying to tackle these challenges using traditional processes and systems need to ask themselves “Is this the most efficient way to do this?”
We know it’s not.
By adopting new technologies that make clinical operations easier and centralising them in a single platform for all stakeholders, the whole team, diverse as it is, functions more effectively. The benefits include a more efficient, more sophisticated trial experience for all involved, better ongoing engagement, and reduced costs.
A New Team View of Clinical Trial Operations
One of the main reasons that clinical trials are slow and cumbersome is the challenge of forging a sense of team between the main players — the site staff, study monitors, and patients.
Provided they are fit-for-purpose, user-friendly, and integrated, new technologies make it possible to foster a true sense of team by bringing all the processes that interconnect the different stakeholders into a single, seamless experience for the whole team.
When considering what technology to invest in, it’s important to consider the needs of the different trial stakeholders, how they interact, and how technology can best support them in working together. The good news is that improvements in any part of the trial process are likely to have a positive impact for everyone. Let’s use patient recruitment as an example:
Site teams want to easily identify and engage with enough eligible patients in a timely manner to meet recruitment targets. They need to feel sufficiently prepared and knowledgeable about the study to engage with patients and take them through the consent process.
Study managers need to make sure their site teams are fully up to speed and trained on the protocol so they can talk to potential participants and ensure truly informed consent. If recruitment is failing, they need to know why so they can make timely adjustments.
Patients want to be aware of all their treatment options. They need to fully understand what the trial means for their care and what will be expected of them from day to day. They are looking for guidance and possibly reassurance about clinical trials and the impact on their health and day-to-day life should they enter a study. Currently, this means reading through lengthy documents to find the relevant information.
A tool that can facilitate all aspects of the recruitment process for all stakeholders can improve the experience for the whole team.
For example, Longboat's Patient CONNECT application and Feasibility and Pre-Screen Navigator online forms can help to identify sites and subsequently help those sites to enrol suitable patients, all while keeping the sponsor and CRO informed in real time using Longboat’s reporting dashboards. Reasons for ineligibility are quickly and easily identified, and trends can be noted so that the protocol might be amended where appropriate to ensure target numbers can be reached.
When you strategically apply new technologies like this across the whole life-cycle of a clinical study, the benefits quickly add up.