Author: Kelly Ritch

How Clinical Operations Teams Can Improve Trial Readiness Through Training in 2020.

ready for clinical trials

There’s a new year underway. What can we do in 2020 to advance the success of clinical trials for sponsors, CROs, and the patients who ultimately benefit? At ArcheMedX, we firmly believe that a critical path to improving clinical trial readiness is improving your approach to training.

What’s wrong with the current approach.

Unfortunately, training project teams and site staff to properly conduct a study rarely gets the attention it deserves and needs:

First of all, the process is often rushed. Secondly, our industry’s heavy reliance on a one-size-fits-all, train-the-trainer model fosters inconsistency in messaging and preparation, a problem that worsens as time passes and staff turnover. This is further complicated by a limited ability to evaluate the effectiveness of the training that is delivered. Too often, we make the mistake of viewing training as a box that must be checked rather than as an essential component of site initiation to conduct a successful clinical trial. We also make the mistake of acting as though training and learning happens at one moment in time, whereas in truth, it needs to be ongoing.

The impact of inadequate training is significant and far-reaching. Inadequate training and a failure to recognize the staff and sites that are not sufficiently prepared can lead to delays in site activation, screening and enrollment, and data deliverables, all of which can lead to extensive delays and drive up costs. Quality is affected when ineffective training leads to high screen failure rates, protocol deviations, and unusable data.

What we should do differently.

So, what should we do differently in 2020? We at ArcheMedX have a few suggestions:

  • Make identifying and delineating the learning that must take place and the knowledge that must be transferred an essential part of planning a study, not just an item on a punch list.
  • Ensure that all training efforts generate actionable data and analytics, so that sponsors and CROs can know much more than whether or not training took place. With data and analytics at hand, they can more accurately determine who is well prepared to actually conduct the study and who needs more preparation. More precisely, they should know which study objectives are well understood and which need to be revisited and reinforced.
  • Acknowledge that the learning required to perform at such high levels as today’s complex clinical studies require is not achieved at a single moment in time. It is, instead, a process, one that requires — and deserves — ongoing attention.

What we have to gain.

Rethinking and upgrading our approach to clinical trial readiness will deliver multiple benefits for sponsors and CROs, and prove to be well worth the investment. Collecting data and utilizing analytics will provide the means to deploy, assess and manage project teams and site staff more precisely and proactively. Better trained staff will deliver higher quality results more reliably. And, delivering high-quality results over time can readily lead to earlier decisions and lower costs for sponsors and CROs.

Learn how ArcheMedX enables peak clinical trial readiness by delivering personalized learning experiences that generate actionable insights.

New Directions in Clinical Trial Preparation and Preparedness

Wecome to another issue of our interview series Conversations in Clinical Trial Readiness, by ArcheMedX.

Check back regularly for more.

Clinical Trial Preparedness

We recently talked with Atlantic Research Group (ARG) executives Shay Brill, VP at ARG, and Erin FarrisSenior Director Project Management, about clinical trial operations, how they are changing, and how they are likely to change. We wanted to share this excerpt from the conversation: 

 

ArcheMedX: 

What are your predictions for how clinical operations will work or should workin the future? 

Erin: 

Over the last year, we’ve been utilizing data analytics more and more. We have a data strategy group here at ARG that focuses on how we can best leverage all of our data from various systems to not only visualize what has been happening to date, but also predict what will happen. I think predictive modeling is where we are heading.   

We operationalize projects with the endgame in mind. At study conclusionhow do you want to analyze and present your data? You really need to start with data analysis first and work backwards, as this will determine how your database will be built. That really drives how you’re going to implement from an operational perspective. 

Project team members are consistently performing aggregate data reviews on each of their projects. They have real-time access to dashboard reports that display key performance metrics and key risk indicators that flag what data needs our immediate attention.  

ArcheMedX: 

Shay, your predictions? 

Shay: 

Our science is getting so complicated at this point . . . We take T cells from patients, modify them, and then put them back into the patients to engage their immune system.  This is not a product that will ever be at CVS or Walgreens. It’s personalized, precision medicineThe aspects of clinical research cause us to look now at a manufacturing supply chain in a much better way—and a much needed way.  

Our technology and analytics are allowing us to step away from matching data in a medical record to what is in a clinical database. People are stepping back and looking at the bigger picture, and at how successful we are at meeting the end goals for the clinical trial and what is happening to the patient during the trial. People are having to learn new ways of assessing that information and making decisions about it. It’s no longer, “How do I travel to the site?” and looking at all the data, and poring over it data point by data point. Now it’s about asking that people have more analytical skills and critical thinking skills than ever before. 

The resource model is shifting. I’ve been in the workforce since 94. I’m continuing to have to increase my technology skills and my scientific knowledge Both technology and science are changing and employees need to continue to learn.  It is not enough to ask how long you have been in the industry, but to truly assess what you know and understand so employers can increase the knowledge areas of their employees and not waste time with knowledge areas that are strong. 

Erin and I just worked on a very complicated study. It took us two or three rounds to understand the science of it. How do we keep growing our skill sets in the face of these sorts of demands? 

ArcheMedX: 

Shay makes a great point. Our clinical operations leaders and project teams need to be equipped with the critical skills, knowledge, and mindset required to meet the increased complexity and demands of tomorrow’s clinical trials Otherwise, clinical studies will be at risk.  

What can we do to gain new expertise on every study when a career involves hundreds of studies? One solution is to deliver more personalized training that provides each clinical leader the skills and knowledge they need to grow and adapt over time. The more effectively we can tailor each learning experience, the more impactful the investment in time and resources will be.  To achieve this goal at scale, we need an approach that more precisely highlights and then targets the areas where teams or individuals are not demonstrating readiness to perform. Efforts like these support more effective deployment of resources in preparing for a successful clinical study. 

 

Click here to learn more about Ready, the clinical trial readiness platform from ArcheMedX that addresses these needs head-on.

Moving the Chess Pieces: A Merck Exec’s Take on the Art of Staffing Clinical Trial Projects

This is the first issue of our new interview series Conversations in Clinical Trial Readiness, by ArcheMedX.

Check back regularly for more.

clinical trial readiness Merck

We recently talked with Adam Kinsey, Executive Director, Clinical Sciences and Study Management—Oncology at Merck, about staffing clinical trial operations. We wanted to share this excerpt from the conversation:

 

ArcheMedX:

When you are working on the beginnings of a clinical trial project, how do you know how to staff up?  How do you plan resources?

Adam:

In a rapidly changing environment like oncology, you could have a program shut down or a program ramp up in a very quick time frame. That’s definitely something that someone at my level is constantly looking at. Do we have enough people in the right roles of study manager versus clinical scientist? Do we have enough people to support what it looks like we’re going to have in 6-12 months? Sometimes, companies go out as far as 18 months.

That’s the big picture, but individual assignments to studies is more of an art form. Say that I’ve got a new study coming up that’s very complex and challenging, and a new therapy area to us. Am I going to assign that to a newer, greener person? Probably not. You factor in those things, balancing the work that people already are assigned to and what’s coming up in the future.

One of the things that’s always hard to manage is CRA resources to do the feasibility and site qualification piece. It’s always tough to assign people to that task, because you don’t even know which of the sites that they’re assessing you’re actually going to go forward with. You don’t make the permanent assignment of CRAs until later.

Ideally, the people who are doing the site assessing, and giving the recommendations on whether to select the site or not, are the CRAs who are going to take that site forward, train the staff, get them up and running, and work with them. That’s sometimes harder to accomplish; That’s two very different tasks. You may go to 50 sites in the U.S. to do qualification and feasibility, but you’re only going to be selecting 25. Well, I can’t assign CRAs to service all those 50 sites long-term, because I don’t know where the 25 are going to actually come from.

ArcheMedX:

You referenced evaluating fit in a complicated oncology study. The number of people involved in a clinical trial is huge. And there’s the turnover to consider. So, are you looking at fit, or preparedness to be working on the trial, during the trial? If so, how you’re monitoring that?

Adam:

There’s a set of metrics around monitoring performance. One example is protocol deviations. You might look across the sites that you have on a study and see that a patient is not supposed to be enrolled; that their liver enzymes are elevated. You see that there’re several patients who have violated the criteria. Those violations are supposed to be recorded by various people who observed them, and logged in the clinical trial management system.

Out of that clinical trial management system, you can get trending data on where protocol deviations are occurring — and begin to see outliers. You can overlay that with data like, “Are we seeing that there’s a concentration of higher levels of deviations with the list of sites that a particular CRA is site managing?” That’s from a numeric quantitative standpoint. You might also look at monitoring visit report turnaround time and action item closures. There are a variety of different metrics that you might use, all of which connect to the clinical trial management system.

There are also quality control visits, in which clinical research managers go out to sites to assess them. They take out with them a series of questions that are very quantitative, in some sense, but qualitative in other senses to check on the health of that site. You can then compare that to the signals that you’re getting from the monitoring visits.

ArcheMedX:

Let’s say there’s an investigator meeting, and you’re getting everybody involved with the trial trained up on the protocol. Is there anything that might happen during this stage that indicates that a CRA, or any individual, doesn’t have a grasp of the content matter of the protocol? Does that also get cross-checked with some of the metrics you look at?

Adam:

There is always a set of questions that you have to complete in order to get credit for that class. It’s generally not that sophisticated; it’s basically just testing that you paid attention. We have a learning management system through which people are given a curriculum for a study, and they have to take courses X, Y, and Z. That system tracks whether you did that, and did it on time.

We haven’t gotten sophisticated with really testing someone’s true grasp of the key messages, or establishing a correlation between people who really paid attention and a reduction in protocol deviations. I haven’t seen anything like that, but it would be really nice.

ArcheMedX:

Do you think an understanding of which parts of the training the individuals have grasped, and how well, could help indicate risk?

Adam:

I definitely think so. You’ve heard of concepts like quality by design and risk-based monitoring, which apply age-old risk management concepts to clinical trials. That’s focusing on reducing errors that are really going to matter to the overall purpose of your study, rather than just focusing on anything that might go wrong.

What are the risks that are really going to be critical to reduce in your program? I think that with any study, you should be making sure that the people who are working on it really know what they’re doing.

ArcheMedX:

Absolutely. One way to address that — and help support the art of resource assignments — is to employ a digital training environment, one that can analyze unique behavioral data to identify leading indicators of staff readiness and provide actionable information to managers so they can more effectively deploy their resources.

What are the risks that are really going to be critical to reduce in your program? I think that with any study, you should be making sure that the people who are working on it really know what they’re doing.

Click here to learn more about Ready, the clinical trial readiness platform from ArcheMedX designed to provide these insights.

We Need Less Guessing In Our Site Selection Process

Site Selection Process

When sponsors and contract research organizations (CROs) make decisions about which sites to include in a clinical trial, they too often rely on outdated historical data and show little confidence in the additional data the sites provide to them. For example, when completing the traditional site feasibility assessment sites may guess or inflate the number of patients that they believe they can enroll. Sponsors and CROs anticipate this response and typically adjust the projections to fit their subjective expectations for each site. They simply don’t have faith in the data that the sites report.


This has been the state of clinical trial site selection. There’s little confidence and lots of guessing.

Don’t Bet on Past Performance.

Fortunately, we live in a digital age and more and more sponsors are employing new methods to collect and analyze a wider variety of data, data that should inspire confidence. However, there’s a warning commonly offered up by the investment industry: “Past performance is not always indicative of future results.” Think about that when you’re considering sites for your next clinical trial.


Currently, the pharmaceutical industry is investing heavily in mining EHR data and patient claims databases to identify viable patient populations at prospective sites. They then combine this analysis with past historical data when evaluating sites — data that might pertain to a different location, a different study team, or a different technology. There are other factors subject to change as well. Given this, just how relevant are those historical data for you and your team planning a future study?


Certainly historical data are a valid input, but one that needs to be balanced with a thorough understanding of the current state of affairs at the prospective site. How confident and capable is the current study coordinator? How committed are the principal investigator and sub investigators to recruiting subjects for your study vs. the five other studies they already oversee?


How can we get this type of insight?

Changing the Site Selection Paradigm

Is there a way to generate additional data that can complement and contextualize the historical analysis or even replace the traditional feasibility survey with a more accurate, confidence based assessment?


The answer is yes. We can leverage proven digital technologies and behavioral analysis to evaluate site feasibility in a more novel way that assesses the confidence, capability, and interest of site personnel.


Sponsors and contract research organizations (CROs) can deliver an interactive experience around the protocol synopsis and key questions to personnel from prospective sites. As the personnel engage with the content and questions (at the time and place of their own choosing) the sponsors and CROs learn about them. Specifically, they learn what site personnel strengths and weaknesses are. They learn how engaged and interested the site is around the particular study. They learn what key concerns or questions sites might have in operationalizing the protocol. And, ultimately, they learn whether or not site personnel are sufficiently prepared and motivated to conduct a successful study.


This approach can provide valuable behavioral insights that help to inform the selection process.

Time to Move On?

Pharma has yet to fully embrace the power of digital technology (and behavioral data), and the industry’s clinical trial operations in particular retain a lot of out-of-date practices. (For example, most feasibility assessments use basic spreadsheets and many still rely on paper surveys) But considering the vast amounts of time and money involved in getting a clinical trial site up and running — as well as the time and money lost when sites must be closed because of failure to perform— it seems worthwhile to consider changing the status quo.

Learn how ArcheMedX enables Sponsors to re-imagine site feasibility to assesses the confidence, capability, and interest of site personnel.

How Might We Improve the Value of the Principal Investigator Meeting?

The principal investigator (PI) meeting is a well-established (and expensive) tradition in the pharmaceutical industry. And, in our era of global programs, you might need to host multiple PI meetings: one for the Americas, one in Europe, one in Asia. Yet, no matter how many meetings you host, you will most likely face a recurring and costly set of challenges.

First, can you get the right players in the room?

  • Despite your best efforts, up to 60% of Investigators may fail to attend the meeting…and that’s before we consider the impact of frequent staff changes over the duration of the study.

Second, how many attendees can sit through eight hours of PowerPoint presentations without losing interest or even falling asleep?

  • As it happens, numerous brain studies show that the average attention span of an adult learner is only 10 minutes. Imagine how often attendees will become distracted if they are not interested in the topics being shared or not actively engaged in some way?

Third, have you heard of the forgetting curve?

  • Even if you run a flawless meeting, most attendees will forget 90% of what they learned before they ever screen the first subject.

This means the real costs and challenges of getting everyone up to speed are much greater than the initial budget allocated for the PI meeting.

Can this model be modernized? Made more efficient? Yes, of course it can. If we are open to new ideas, we can transform the traditional PI meeting into a far more effective experience that lays the groundwork for a successful study, one with fewer missteps and less waste.

Let’s Prepare Content Based on What Attendees Already Know.

In preparing content for PI meetings, we typically start by guessing what attendees know and don’t know. We also guess about what content they will find challenging and what they will find easy. There’s no reason to play this guessing game today and waste valuable time during the meeting. Instead, invest in assessing your meeting attendees’ knowledge before finalizing meeting content — and make time spent at the meeting both more productive for you and more engaging for attendees.

How might this be accomplished? Some sponsors distribute a survey or ask for feedback after sharing a protocol synopsis. However, these informal approaches yield minimal feedback and insight from a limited number of potential attendees. A more novel, digital-based approach can be designed to engage PIs and Study Coordinators around content and critical questions ahead of time, providing valuable insight to meeting planners and content developers.

Let’s Properly Train Those People Who Won’t Attend the Meeting.

Not everyone who must perform at a high level on a clinical study will attend the PI meeting. There will be scheduling conflicts, competing priorities, and travel constraints. Because the meetings are expensive, the number of people who can attend may be limited. Consider, too, that over the course of a program there will be staff turnover. New sites may be added. How will the newcomers be trained? How effective will the second-tier training be? While there are reasons to employ a train-the-trainer model, one industry insider described the approach as akin to the children’s game of “whisper down the lane”.  There’s a clear problem with consistency.

Instead, why not capture those PI meeting activities in an enduring program that others can access as necessary on their own time and from their own locations? In addition to guaranteeing accuracy and consistency, such programs can be structured to provide insights that let sponsors and contract research organizations (CROs) know exactly how well material has been understood, where the learners’ strengths and weaknesses lie, and how well prepared the learners are for participation in the study.

Remember That Learning Is A Journey.

A PI meeting occurs at a moment in time. That “moment” could be close to the time when investigators will sit in front of their first subjects, or it could be many months prior. As mentioned earlier, numerous studies on adult learners tell us that 90% of what is learned will be forgotten after one week. How much of the information presented at your PI meeting will be retained months later when it must be applied?

Incomplete or lost learning leads to problems like protocol deviations and early high screen failure rates. Many of these missteps could be prevented if we accept that learning is a journey that should be personalized and reinforced over time.

Imagine if you could identify where participants were most at risk and then nudge them to dive deeper into those critical study objectives until they mastered the topic.  Imagine if you could enable learners to increase and solidify their knowledge in the days and weeks that follow the meeting instead of forgetting most of what they learned. Imagine if you could give sponsors and CROs continuing insight into how well prepared the team is.

It’s Age-old But Brand-new.

Preparation. Education. Analysis. Feedback. They are all simple, timeless techniques. But paired with today’s most advanced software and systems, they can deliver never-before-seen levels of clinical trial readiness for sponsors and CROs. You might even decide that you really don’t need those PI meetings after all.

Learn how ArcheMedX enables Sponsors to transform the traditional PI meeting into more personalized and effective learning experiences.