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International Clinical Trials

Synchronised Learning

With organisations operating in a global environment in a digital age, no business can afford to fall behind with their site staff training programme. Brendan Buckley at Firecrest Clinical explains how a hybrid model of tailored, focused meetings using web-based platforms can ensure that every member of the study team is adequately informed, regardless of where they are in the world

A hybrid model of coordinated investigator site training ensures that appropriate training is given to site staff and puts all sites on an equal footing globally.

The clinical trial industry, like many others, is undergoing a period of change, and with clinical studies becoming increasingly complex, so too are the day-to-day demands on site staff, requiring a more efficient and effective means of managing studies at sites.

The industry is also witnessing a shift from the longestablished and deeply ingrained model of global investigator meetings, initiating and training site staff at the beginning of a study. Designed to introduce principal investigators (PIs) to the trial objectives and protocol training, investigator meetings are usually held six months in advance of site initiation, potentially placing an unfair expectation on site staff to retain and execute training received far in advance of their actual participation in the study.

A BETTER WAY TO LEARN

The current design of a typical investigator meeting is not conducive to interactive learning. Overused and repetitive presentation methods are never going to fully engage site staff in a clinical study. One only has to use the term ‘death by PowerPoint’ in front of a group of study personnel to be met with a sea of nodding heads. In addition, there is the issue of language barriers for certain delegates whose native language is not English. Many industry professionals have undoubtedly been in the typical investigator meeting scenario where they turn to converse with another delegate at a session or dinner, only to discover that their English is extremely limited. With English being internationally accepted as ‘the language of clinical research,’ it goes without saying that many individuals attending an investigator meeting delivered in English cannot be considered to be effectively trained on a study protocol and are perhaps at an immediate disadvantage on the study. The possibility of the localisation of training into several languages means that this barrier can be swiftly and effectively overcome, putting all sites on an equal footing.

A HYBRID APPROACH TO MEETINGS

While it is true that the value of investigator meetings can never be underestimated, when it comes to industry networking and peer-to-peer relationship building, a new model is emerging to address the acknowledged inadequacies of the traditional investigator meeting from a training perspective.

Ideally, what the industry needs is a hybrid model of training via shorter, regional and more PI-focused meetings, combined with web-based, certifiable training for site staff at key milestones throughout the study.

A PI attends an investigator meeting to absorb the trial objectives and drug compound information, but in most cases should not be asked to sit through hours of lengthy vendor presentations, which are of more relevance to the site staff. Neither is it practical or possible for all site staff participating on a study to attend an investigator meeting to learn first-hand from the presenting vendors. Therefore, those that cannot be there are at somewhat of a disadvantage when they are initiated onto the study. Can a sponsor ever be confident that site staff across a global study are all trained and equipped to execute and report study procedures to the same high standard?

Simply put, each group of study personnel receives a tailored initiation to the study to meet their separate needs:
  • PIs complete a protocol-specific training module in advance of a regional investigator meeting, thus reducing the time required to sit through lengthy presentations that are of little interest to the PI
  • Monitoring teams receive in-depth, face-to-face training as a separate group, including detailed instruction on the introduction of site staff to a web-based interactive system
  • Site staff perform online training immediately prior to their scheduled site initiation visit date
CUSTOMISED STUDY PORTAL

A centralised web-based study portal can provide all participants with one username, one password and one URL to access customised training modules designed specifically for their role on the study. In addition to training modules, the site can host a centrally-located operations manual for the study, as well as detailed immediate instructions individualised for each participant and each step of the trial. Such a site can facilitate seamless access to EDC and IWRS as well as documents, reports and study metrics, with additional features such as online meeting centre functionality to improve study communication globally. It acts as a central repository for training, essential trial documentation, as well as step-by-step, point-of-care procedural information. Live data feeds to the study portal deliver regular updates to all users on patient recruitment, randomisation, top recruiting sites, and so on. When real-time coordination of study personnel is required, the study portal’s online meeting feature can act as an interactive digital meeting site, eliminating the need for travel.

What does this mean? One web-based study portal linking all the various clinical trial management systems and tools for the study, thereby eliminating the burden on site staff to get to grips with several different technologies and complex user menus.

TRIAL IN YOUR HAND

Recent and rapid advancements in mobile technology now mean that, more than ever before, site staff can access the information they need when they are away from their desktop and by their patients’ sides. Mobile devices and applications ensure that a study portal can be a portable platform enabling site staff to enter real-time data as they receive it, reducing the dependency on cumbersome and antiquated paper-based systems. Imagine the potential for the speed of a clinical study to be increased and the number of careless data errors to be reduced, all ultimately facilitating the complicated voyage of clinical compounds to market.

IMPROVED TRIAL PERFORMANCE

The bedrock of clinical trial conduct is that the protocol must be meticulously and faithfully applied; to this end it is paramount that training is delivered to sites in close proximity to the date of site initiation. This strategic method significantly improves retention and individual performance in key aspects of the trial. Current industry trends demonstrate that clinical trials deploying such web-based and mobile technologies at their sites are reporting increased patient recruitment in addition to reduced protocol deviations and data queries. With typical data queries costing in the region of $80 to $100 per query, these reported improvements are of great significance to sponsor companies who are under increasing pressure to streamline overall clinical trial costs. Consider the current issues within the investigative landscape:
  • Burdensome investigator meeting design
  • Language barriers for study personnel
  • Outdated and unimaginative training format
  • Global communication inefficiencies
By improving communications at the site level, compliance, consistency and quality of execution throughout the life of the study is greatly enhanced. Requiring study staff to login to gain access, for example, not only secures data from unauthorised users, but provides the project manager with a record of each staff member’s ongoing interaction with the study portal.

Each team member can be tracked to ensure training has been performed and is understood, procedures are followed, timelines are met, and study parameters are maintained. This also allows the study manager to analyse performance on a site-by-site basis – to determine the percentage of sites that have reached a particular milestone, for example – and to guarantee compliance to the requirements set by regulatory bodies.

With the hybrid model of tailored, coordinated training delivered to trial personnel groups, along with localised, stepby- step instructions for all site staff across a global study, the variances in study procedure execution and data reporting, which are hampering clinical trial efficiencies, can be effectively overcome.

CONCLUSION

In a global environment and a digital age, reliance on outdated methods of training and communication hinders a clinical study’s chance of success. By placing training, operations information and data collection on a web-based platform, every member of the study team – from a CRA in a far-flung clinic to the study sponsor – can get exactly the information they need, whenever they need it, regardless of where they are in the world.

Combining these capabilities with focused regional face-toface meetings is proving to be one of the best methods for significantly reducing protocol deviations and data queries, lowering overall trial costs and greatly improving the chance of investigational products proceeding to the next phase of clinical research.


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Brendan Buckley is Founder and Director of Medical Affairs at Firecrest Clinical, Ltd and Firecrest Clinical, Inc. Brendan has extensive experience in clinical trials and is a member of numerous independent data and safety monitoring boards for medium to large clinical trials. He has published extensively on both the results of clinical trials and their methodology. In addition to his role at Firecrest, Brendan is Clinical Professor of Medicine and Pharmacology at the University College Cork (UCC) School of Medicine and the National University of Ireland. Email: info@firecrestclinical.com
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