Benefits for Investigative Research Staff
Electronic and digital aren’t the same thing. So, what does it mean when the protocol is digital? We believe that answers are available in seconds, contextually aware, and present with the patient.
Answers in Seconds
In the digital world, you ask a question and you get an answer. Under the covers, the search engine is analyzing all of the available information to generate the most relevant results – in seconds.
In clinical trials, there are multiple questions. And answers may come from a variety of documents beyond the protocol, including investigator brochures, lab manuals, CTCAE, etc.
What if any research staff could type a question into a search bar from any digital device and the results are returned in seconds after analyzing all available documents? The focus then shifts to the best answer instead of what section of a document. It reduces the burden on the user because the best answer is found among all of the documents. And it also eliminates any worries about document version because answers are only returned from the approved, current protocol for that site.
Let’s take the example of “hypertension.” It may be part of the eligibility and so it may appear in either the inclusion or exclusion criteria of the protocol. But if during the trial a patient develops hypertension, the word could also appear in the toxicity management section of the protocol.
A simple scroll through the index of a PDF directs the user to a list of topics but doesn’t necessarily answer the specific question. Similarly, doing a keyword search in a PDF would return multiple hits to the keyword, which then puts the onus on the user to look at the context of each instance of the word.
What if a physician could just type in eligibility 140/90 – and get an answer whether the person is eligible for a clinical trial? Or dose 160/95 to understand whether to modify dosage based on the current blood pressure levels? Physicians and nurses can spend less time and be more precise to find answers in the context of their questions.
Present with the Patient
Time with patients is limited. Decisions need to be made quickly and in compliance with the protocol. Whether the patient is eligible for a given clinical trial, what conmeds are permitted, and which procedures should be performed for a given visit, investigators and research staff need to make decisions from the latest study information.
From any smartphone or digital device, answers from the protocol are always where the patient is. This means physicians and nurses can focus on patient care. For example, protocols may be amended to update enrollment criteria. Therefore, it is critical investigators and research staff have the latest study information when they are with patients to enroll the right study participants and reduce errors. Gone is the need to walk to another room to log into a computer or flip through paper.
What’s in It for Sponsors and Monitors
If sponsors and monitors aren’t asking how research sites are interacting with the protocol, they should.
First, it is a measure of how engaged sites are with the trial. Actively looking at eligibility criteria, for example, is a good indication of whether sites are trying to recruit for the study. It also speeds enrollment of the right patients because research staff are confirming the criteria on the spot. Second, conducting trials strictly by the protocol reduces errors, minimizes deviations and protects patient safety.
Sponsors and monitors have a role to play in helping to alleviate the burdens on research staff in conducting trials. And they both have something to gain with better visibility and earlier insights into trial performance.
It may sound obvious, but paper protocols don’t give sponsors or monitors any idea who is looking at the protocol or what answers they are trying to find. Similarly, “electronic paper” documents don’t offer much more insight.
Usage trends of portals are nice to have stats – if you can get them in the first place. And unless you are regularly running a report, they offer a picture that is after the fact. And usage still doesn’t answer the question of what the person was really looking to answer.
When the protocol is truly digital, sponsors and monitors can see in real time who is looking at the protocol, how often and what they are trying to find. In fact, remote monitoring necessitates this digital insight.
CRAs can target precise support for sites who aren’t meeting their enrollment targets. Site queries can also be handled faster. And central monitors can compare usage trends across sites to evaluate key indicators, such as enrollment or protocol deviations.
With real-time insights, sponsors and monitors can proactively address risk factors. High profile search terms may indicate safety issues, while high frequency search terms could highlight where further clarification is needed.
Let’s take the example of toxicity management. If there are known symptoms that could be an early indicator of a known side effect, alerts when sites are searching for this would allow sponsors to react more quickly to guide the investigator on specific actions.
Similarly, if there are consistent questions in the same area, such as permitted conmeds or certain eligibility criteria, sponsors could provide clarifications to monitors and site staff so that everyone has consistent, real-time guidance.
Sponsors have a window to see into the trial performance. By connecting sponsors with the staff conducting the trial, they have a better understanding of performance and can proactively offer guidance or additional support for items blocking sites and trial success
Where Do We Go from Here?
At the end of the day, it’s about making it simpler for research staff to safely conduct clinical trials so that life altering treatments can safely come to market faster.
We see that research sites are stuck in a bit of a time warp. Physical paper is still a dominant source of information. Even when the protocol is referenced “electronically,” it is used more like paper on a desktop than a digital resource. There is still a reliance on CRAs as an information source, which delays responses to questions.
If you think about the patterns in your own life, how much of it is digital and mobile? Physicians, nurses and CRAs aren’t any different. And as we have more “digital native” staff, it is unlikely that they will be satisfied with antiquated practices.
With COVID-19, paper itself poses risks of contamination. And with more remote monitoring, clinical trials must move to be more digital.
Speed and quality of answers are critical to any clinical trial. In a digital world, answers for research staff are just a couple of clicks away – anytime, anywhere. Every answer provided itself tells a bigger story for sponsors and monitors to evaluate trial performance and proactively address issues.
Want to learn more? Why not book a meeting with our experts.