Is Your Clinical Trial Protocol Fit for Purpose?

In this session, we would like to ask a simple question is your paper protocol really fit for purpose? I say really with emphasis, because we would like to challenge you to think differently about your protocol. Why? because we believe that the status quo is not good enough.

While incredible advancements have been made in modern medicine. Much more can be done if clinical research were more simple, transparent and accessible. Let's say you were going on a trip either for business or pleasure. Most of us would go online to book everything, probably never even talking to a person.

And certainly not referring to any paper catalogs. How about booking a restaurant? Are you more likely to book using a telephone directory or by going online to book the restaurant for the exact time you want? What about if you need directions?

Are you more likely to take out a paper map or go online to get precise directions from exactly where you are to exactly where you were going? I think you can see the point. We rely on our smartphones or digital devices to manage everything in the rest of our lives. Current reliable information is always at our fingertips, and you don't have to be particularly tech savvy.

So why then do we still rely on paper protocols for clinical trials? Why is the primary interface to the trial? The protocol not kept pace with modern technology. Sure, there are compliance and regulatory considerations, but even the regulators are promoting the value of technology to ensure trial, safety and adherence to the protocol.

In clinical trials, everything starts with a question. For Seitz death, every action they take starts with a question is this person eligible? For which trial? What should I do with this visit?

How should I manage this toxicity? The answers, as we know, are in the protocol. But when was the last time someone looked at the protocol? Unfortunately, if it's on paper, you just don't know.

The trouble for many research sites is that the main job of their doctors and nurses is to deliver normal clinical care to patients. This means clinical research is not their primary business. Doctors and nurses are limited for time and have to make quick decisions when they are with a patient. The reality for sites look something like this.

The protocol is in one place. The study coordinator is in a different place. The sub investigator is yet in another place. The participant may not be where any of them are, but access to the protocol is key.

Every time, everywhere, take adverse events. For example, serious adverse events don't keep doctors hours. They can occur at any time. If the doctor gets a call from the patient in the middle of the night about a bad reaction, how does he or she know what to recommend?

If the protocol is not immediately at hand for patient safety and the integrity of the trial, the only reasonable approach should be to check the protocol directly to make a decision. It's not surprising that one of the biggest problems is the lack of adherence to the protocol. This chart from the FDA speaks for itself. You can see the majority of violations are related to the protocol versus other types of citations.

This could be because staff are following the wrong version, have the wrong interpretation, or generally just fail to follow the protocol. If the protocol is inaccessible, it is not hard to see why this remains a problem. Let's look at it from the lens of the monitors. Sure managing clinical trials is the business of cras.

The complexity of the protocol makes it difficult to ensure sites are strictly adhering to the protocol and procedures. Monitors have the added complexity of staying up to date on all the active versions of the protocol for their sites and making sure sites use only the correct approved version on top of it. There is also the issue of high staff turnover among Syria's. If we look at some industry research conducted by Viva systems, we see that both Ceo's and sponsors primarily interact with sites via email.

For syros, the second most common means of sharing information is paper. Seriously, how can we still use paper to share critical clinical trial information? The reality for monitors is something like this. Karas are often tasked with managing decisions between research staff and the medical staff.

They are usually responsible for multiple sites. Each one could be on a different version of the protocol, and each one might have study coordinators trying to reach the c.r.a. because they need to confirm a procedure, or they aren't sure how to interpret something in the protocol until they get answers or decisions. Sites are blocked. This era, as a switchboard model can take precious time, and it introduces the chance for errors in transmitting decisions.

This brings us to sponsors with traditional monitoring reports can lag by weeks or more. This means sponsors may not have the most current information on what's going on with their trials. Are sites engaged with the protocol? What issues are they having in recruitment?

What early indications might they see about potential safety issues? If sponsors get information that's several weeks old, it may be too late to take any proactive action. Sponsors rely heavily on email to share information, which you can see from this chart. This is from Veeva Systems research, as we've already touched on.

Sierra's have heavy workload supporting multiple sites and if there is staff turnover, emails may not be transitioned from one Sierra to the next very efficiently. How many important emails are missed? Just think about your own life. How many unopened or unanswered emails do you have?

It's frightening to think that vital trial information could get missed or delayed in a Sierra's inbox. For sponsors, the picture looks something like this. Sites around the world are waiting for answers or decisions from the c.r.a. By the time the information gets from the sponsor to the c.r.a. to the site staff, imagine how many days have passed. And what if this information could help with study recruitment or better adherence to the protocol or managing toxicity?

We strive to be the best that we can be in professional, academic and personal pursuits. Protocols which have been available to sites for decades are a long way from the best that they can be. It's not just a nice to have area of improvement in clinical research. It is essential.

It is time that we move into the 21st century that we make the protocol always accessible anytime, anywhere to all site staff. It is not a leap. We are already digital in the rest of our lives. Why not clinical trials?

What are the requirements for a modern approach to the protocol? First and foremost, it must be simple and easy to use. Everyone at a site must be able to access the protocol any time, anywhere. It must provide immediate and accurate answers to all kinds of questions every time, everywhere.

Version management is also a key requirement. Sites must have only the right documents approved for that site. And finally, it must be compliant with regulations and audit. Ready what we are talking about is turning your protocol into actionable data, transforming the protocol from a static physical document into meaningful data for everyone.

Research staff. Monitors and sponsors. For research staff. When the right version of the protocol is always immediately available, it means faster recruitment, fewer protocol deviations, and better handling of safety issues.

Investigators will have answers at their fingertips, even if patients call in the middle of the night and staff can quickly and correctly assess whether a person is eligible for a given trial for monitors. It means that they will have the information to better plan site visits. For example, they can prioritize sites that need the most help to meet recruitment targets. Cras can also reduce the time it takes to provide answers back to sites, and it is more efficient to keep sites informed of important trial information for sponsors.

It means sites and monitors have the information they need when they need it by making it easier to run trials. Sponsors can better compete at the best research sites, and sponsors have information sooner to address issues blocking sites. In the end, trials are safer for patients, and it reduces time to market with life saving drugs at tech row. We are all about making clinical trials more simple, transparent and accessible.

How do we do this? With immediate access to answers. Anytime anywhere. Every time. Everywhere tech row cloud based clinical trial software is accessible through any digital device or smartphone.

This means that answers from the protocol and any other study documents are at your fingertips. It's easy to use. Research staff simply type in a question and an answer is returned in seconds. Thousands of research sites are already using tech row around the world, and what is remarkable is that they aren't forced to use it.

Research staff used tech row because they love it, because it makes their jobs easier and trials safer. With tech row monitors and sponsors can see what questions are being searched. Search trends can indicate potential safety issues or the need for clarifications. They can also show what sites are engaged with a trial.

Sites that are searching the protocol are far more likely to enroll patients than those not monitors. And sponsors can also make sure that the right version of the protocol is always available for each site. This reduces protocol deviations due to sites following the wrong version. It is time to modernize and simplify clinical research by transforming the protocol into actionable data for everyone.

The right patients are recruited faster. The protocol is more faithfully followed, and safety issues can be swiftly addressed. We manage the rest of our lives through our digital devices and smartphones. Why not clinical trials?

Why not make protocols the best that they can be? To find out more. Book a demo at tech growcom. Thank you for your time and your attention.

If you have a study question, tech drove the answer.