The value of a clinical trial management system (CTMS) cannot be over-emphasized. In short, it is the type of purpose-specific industry technology that contemporary clinical trials cannot do without. And clinical trial staff have come to rely heavily on their chosen CTMS for tasks such as easier site selection, improved data management and greater flexibility in trial design and management.
In this post, we explore how CTMS best practices can not only facilitate ease and simplify the running of a trial, it can also help staff adhere to the most rigorous clinical standards.
There are a number of key areas upon which clinical trial staff should focus to ensure best practice, says Ted Finlan, SVP of project planning and administration at Worldwide Clinical Trials.
To overcome the lack of interdepartmental and inter-organizational communication, trial staff need to ensure effective flow of information. Imagine if the unit responsible for quality learns of new regulations that could affect the study start-up process but does not share it with other trial staff. The risk could be huge, impacting timelines, trial objectives and threatening the whole study.
Communication should always be clear, Finlan explains. This means each staff member must know what their role is in the greater study. How does their job affect others and what are their specific responsibilities?
It’s vital that trial managers and sponsors do their best to overcome any uncertainties in the trial. This is a fantasy, of course, as uncertainty cannot be eradicated; however, the more uncertainty, the greater the stress on the budget. Delays, supply chain issues, patient and staff attrition, and many other factors can impact the budget.
This means that all staff need to be adept at managing change and, indeed, planning for the unplannable. It can also come down to incentivizing key staff members, such as those from the CRO to ensure timely performance is encouraged by financial incentives.
No sponsor wants to pay for an over-staffed trial, but having too few team members can lead to severe inefficiencies. The best practice here, Finlan says, is to allocate resources in a holistic manner, such as by ensuring core processes are integrated and definitions and metrics shared.
Training staff as to clinical best practice is essential, but it’s important to pitch the training sessions at the right level, writes Caitriona Riordan McCarthy, head of instructional design at Longboat.
She says you need to motivate site staff as well as educate them. Lessons about keeping study participants informed, confident and safe, should be offered in “bite-sized chunks” instead of requiring uninterrupted hours. This will better accommodate a target audience that is busy and managing many interruptions throughout the workday.
Storyboarding is a good approach: It breaks text-heavy documents about protocol into more manageable and memorable segments of information, Riordan McCarthy adds. Using images also cuts across any potential language barriers, ensuring that staff has a clear and visualized requirement of what they need to do throughout the trial.
As of 2017, the NIH’s Good Clinical Practice set standards that NIH-funded investigators and staff must meet to ensure clinical best practice. The policy demands consistency with the principles outlines in the International Conference on Harmonisation (ICH) E6 (R2).
Any staff and investigators involved in trial management conduct and oversight will need to undergo training. The NIH-funded investigator is responsible for trial conduct at a site and, when conduct is managed by a team, the principal investigator is considered the team leader. The rest of the clinical trial staff is comprised of team members to whom the investigator assigns responsibilities for the study’s coordination, collection and management of data, patient recruitment and enrollment, and recording patient consent.
Not to wax hyperbolic, but a CTMS is an essential. Indeed, Srini Dagalur, Ph.D., VP digital services and health at Deloitte Consulting argues that a CTMS reassures clinical operations executives, removes organizational boundaries, increases interoperability and simplifies compliance.
Consider, Dagalur explains, the benefits of using a CTMS, which include:
By integrating processes by multiple staff members performing their various roles, the CTMS records and shares relevant trial data and protocol with those who need it. But its value also lies in the CTMS-specific standardization of inputting information. This means staff must adhere to specific formats and operate within defined limits to minimize inaccuracy and increase efficiency.
Equipping staff with knowledge of how to use the CTMS is essential to achieve best practice by implementing the system, the team at CRO Training says. Before adoption and implementation, staff need to know why they should be using the CTMS and how it will benefit them.
Start with why it is a positive addition. Communicate the many benefits, such as managing workloads faster and improving information flow between teams and staff. It’s also useful to listen to their opinions about the CTMS. What do they want and need it to do? What are they worried about when implementing it? Once trial managers know the concerns, they can allay them.
This is what senior training specialist Anne Gerke at Forte Research suggests too. Determine what you want from the CTMS and explore what your staff thinks about it. How will it help them and how do they feel it might hinder them?
Collectively define what the CTMS should help staff accomplish; how many processes the CTMS should replace; whether the system should be rolled out all at once or implemented in segments; and how staff want to be trained using it.
Choosing a CTMS champion among staff, Gerke explains, is a useful means to ensure successful training of staff in the system’s use. Make sure the champion is a keen communicator and extremely knowledgeable about the system.
One of the benefits of using a CTMS is that is collates relevant data from multiple sources into one accessible database, explains Rupert Lang corporate operations manager at contract research organization GKM. Indeed, this approach of how they can contribute to the same goal is what trial staff should consider in all aspects of data capture and communications.
A CTMS allows for better planning of the trial but also faster reaction time to changing needs. It allows staff to constantly monitor the progress of the study, identify potential problems before they beset the trial and opens up any possible bottlenecks of data, processes and actions. This means that staff should also be anticipating potential problems and ensure they are equipped to solve them quickly.
At ClinPlus, our CTMS is designed to help sponsors and CROs overcome technical challenges when running trials, improve user accessibility and communications, reduce the number of manual operations and eradicate redundant data.
This all leads to greater efficiency. Choose a CTMS that speeds up the study setup, provides templates for important documents and reports, facilitates better document management and enables the recording, processing and transferring of data.
A decent CTMS will also improve enrollment rates, streamline scheduling and task assignation, as well as enable integration with other technology such as EDC and IxRS products and web services.
Training staff quickly to use the CTMS does more than improve operations and facilitate best practice: it also improves the ROI on the technology.
As Anna Hrovat-Staedter at Forte Research notes, a CTMS improves the running of a trial but without staff operating it correctly, much value will be lost. Effective user adoption is dependent on training staff at all levels and in a thorough manner, she adds. Faster adoption and seamless implementation will lead to higher long-term returns through more efficient practices and improved problem solving.
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