Author: Kelly Ritch

4 Things to Do Now While Clinical Trials Are on Pause

While industry media are reporting that some clinical trials that had been paused are restarting, much of our industry remains stalled due to COVID-19. If you’re among those still in limbo, you may be struggling with how to prioritize your time right now to prepare for restarting. We’ve put together some suggestions designed to significantly reduce the impact of future threats to clinical trial operations.

Determine what worked and what didn’t.

Start by acknowledging that we’ve all received a wakeup call. We’ve been brutally reminded of how agile we need to be to protect important research. We know we need to work on strengthening our contingency plans. Start by asking yourself, “Where did my plans hold up, and where did they fail?”

For years, there has been a great deal of talk about moving to digital solutions. Yet people hold fast to old ways of doing things and comfortable processes. After all, trying new things can be difficult, especially when the pace of activity is as fast and relentless as it is during a clinical trial. Unfortunately, the current crisis has shown us that there is a cost to not evolving and adapting, and it can be huge. We need to use this disruption to embrace new technologies and claim the value that they offer.

For example, are there opportunities to use more digital asynchronous components to speed up and focus the site initiation process? Is it possible that asynchronous investigator meetings or training could be a way to keep things moving? It’s possible that many of your existing processes are ripe for a digital overhaul. Considering this now may pay off in the short term if we are hit with another spike in COVID-19 activity. Better yet, you may find enormous cost and time savings in the long term and be better prepared for whatever comes next.

Assess what your needs are.

What additional technology do you need to put in place to mitigate future disruptions and help ensure that trials can continue? In considering, ask yourself these questions:

• What activities are currently delivered in person that will need to be transitioned to a remote or virtual process and what information will I need to deliver via alternative means?
• How will I ensure my staff and sites are adequately prepared to conduct the trial and evaluate team performance if people cannot meet in person?
• What systems could I use to deliver high-quality, consistent, asynchronous information and how will I ensure that staff and sites understand critical changes to the protocol?
• If my site staff isn’t able to see patients, what additional skills do they require to execute the protocol? How will I equip them with these additional skills?
• Will there need to be additional roles or personnel involved in the conduct of the study? If so, what will be the best way to onboard them remotely?


Commit to communication.

Don’t make the mistake of undervaluing effective communications. Consider that every change you make must be supported by communications with your project team, your site staff, and your patients. There’s skill involved in effective communications, particularly in effective, patient-centric communications, and now, when communications must replace actual patient contact in many cases skillful communications are more important than ever. It’s wrong to assume that nurses, study coordinators, and doctors are all naturally adept at delivering the important messages that support your clinical trial. At least some subset of these people will need help in developing communication skills. Providing relevant training in this area is an important step you can take now while your trial is paused.

For example, are there ways you can help equip sites with what they need to communicate to patients? Handing sites a thought-out communication process with talking points or content approved by you could set them up for success when your trial picks back up.

Fill the gaps where you find them.

Communications training is just one element of a larger improvement plan you might develop for your staff. What other skills need to be developed or honed to facilitate high performance under unusual circumstances? What is your team ready to do right now? Where are there gaps in their capabilities? If you don’t know the answers to these questions, consider how will you go about assessing your team?

Address those gaps by putting additional learning in place, especially as concerns key changes you expect to make in your protocols and procedures.

Most importantly, while navigating today’s challenges, proactively invest in moving forward with confidence that contingency plans have been bolstered and technology implementation has been optimized. No one wants to repeat the lessons we’re learning right now.

ArcheMedX can help.

Need advice on where to focus first on equipping sites, investigators, your study team, or patients? We can help you discover ways to optimize processes with digital solutions. Reach out to us at ArcheMedX now.

Interview: The People-First Approach to Success in Clinical Trials

We recently spoke with Carl Cook, Vice President of Clinical Operations at Black Diamond Therapeutics, a biotech focused on the discovery and development of precision medicines for cancer. The company is based in Cambridge, MA. We wanted to share these excerpts from the conversation:

ArcheMedX:

What are the biggest and/or most common challenges you encounter during the preparation or conduct of a clinical trial?

Cook:

The first challenge is assembling a dynamic, cohesive, diverse, experienced team that is aligned on the hypothesis to be tested and understands it so that we can put together a plan, not only for executing against the project priorities, which includes writing the protocol, presenting the compelling science, and, of course, testing the hypothesis.

ArcheMedX:

How do you know a team is aligned?

Cook:

As a leader, you have to “check-in” on a regular basis to make sure that each team member is focused on the same goal, the same delivery time frame, and the same response to a challenge. The other piece is clarity — clarity of purpose and clarity of response. And, we must all have a common alignment around focusing on the patient. If we focus on doing the right thing for the patient, everything else will follow.

ArcheMedX:

How do you go about checking in?

Cook:

I have formal meetings with the key leads on the team twice a week. I also have one-on-ones with each of the leaders during the week. So, each day I do an assessment of our alignment and our ongoing challenges — the inherent challenges of running an early-stage oncology study and then the added challenges of COVID-19.

 ArcheMedX:

Could you provide an example of good alignment and the result of it?

Cook:

I think back to the experience of 9-11. That morning, we were in a global team meeting with approximately 100 colleagues. One of our biostatisticians walked into the room and said, “We need to turn on the television.” We soon learned what was going on. It was surreal. We needed to take a moment and focus on getting clarity: What is it that is actually happening? What is the impact? Then, we knew we had to check in with each other. We needed to know that we were all okay. We needed to check that colleagues who weren’t in the room were also okay. And we needed to make sure that families were okay.

 

ArcheMedX:

The events of 9-11 came out of the blue, while the COVID-19 crisis developed over time. Does that make it different for you?

Cook:

In both cases, my approach starts with team check-ins. I make sure every day when talking with my direct reports and colleagues that we start by asking how everyone is and what they need. Our leadership has been fantastic in ensuring that any support anyone needs is provided. This allows us to clearly focus on the patients [on the study]. We have a team of dedicated professionals who cares about what we do for patients. That’s why they’re a part of our team.

ArcheMedX:

Is your work ongoing? If so, have you changed anything?

Cook:

Our trial is continuing. The only thing significantly changed is the amount of time and energy we spend focusing on how well people are doing personally and professionally.

ArcheMedX:

How do you typically go about training site staff?

Cook:

We invest significant time and effort in meetings on the protocol and on the responsibilities of the investigators and the research staff. Of course, now we’re conducting meetings via video and WebEx, etc. We’ve also put in place different tools and templates that we use to educate our internal staff, our partner staff at our CRO, and, of course, our site staff.

ArcheMedX:

There is so much information that must be shared before and during a clinical trial. How do you know that your staff is adequately prepared?

Cook:

We do a lot of dry runs. For example, before we would put a team member in a key role presenting at a site, we hold a lot of internal mock site initiation visits. And then we actually do a sort of see-one, do-one, teach-one kind of thing. We let people observe first, then we run them through presenting perhaps a part of the protocol, and then we have them present it internally a couple of times before they actually present it to site staff. Refinement comes with repetition.

ArcheMedX:

Anything else you would like to share with us?

Cook:

Yes. Always remember that there is a patient on the other end of that data point, and before you finish a protocol, make sure that you have consulted with a patient advocate and that your investigators involved in conducting that trial have provided input, because, at the end of the day, that’s going to give you a protocol that works well for investigators, for testing your hypothesis, and for patients. Taking the extra time to get it right for your investigator staff and your patients makes a world of difference.

ArcheMedX:

At ArcheMedX, we align with Carl’s people-first approach to designing and running clinical trials. After all, we are the strongest and most successful when we connect with each other and care for each other.

How to Be Sure Your Team Understands Important Updates to your Clinical Trial

Your protocol has been amended. There’s been a key finding that requires a change in procedure. Maybe there’s a new working practice document. Whatever the specifics, vital information has been dispersed to the team and all individuals have acknowledged that they have read it. But how confident are you that everyone who needs to understand the information really does? On what is your confidence based? 

For an industry devoted to scientific study and evidence-based medicine, we take a lot on faith. 

At ArcheMedX, we have found that almost no one currently assesses whether or not clinical trial staff truly understand important trial updates like protocol amendments and new SOPs. Many sponsors don’t measure staff competence or confidence. They don’t even verify whether or not important documents or key written communications are actually read 

Keeping Up With It All 

A number of things change over the course of the average clinical trial. Today, as we all struggle to find the path forward in the age of COVID-19, we can expect there to be a great deal more modification of procedures. For clinical trial teams, that means more to absorb, more to understand, and more to master. For sponsors, that means more risk.  

If you don’t want to live with this level of risk hanging over your clinical trial operations, you’ve got to move beyond simply asking people to check a box and affirm that they’ve read a documentYou must be able to assess their understanding. And, where understanding is lacking, you must be able to systematically address the problem and monitor improvement. 

 

Procedures, Protocols, and People, too

Procedures and protocols aren’t the only things that will be changing in clinical trials. Job roles and responsibilities will change as well. Clinical Research Associates (CRAs) are now doing remote monitoring, and a lot more of their visits are via the telephone. Consider your statisticians. In the days ahead, they will need to do more in the area of managing and interpreting missing data due to the impact of the pandemic. Medical writers need to know how to quickly handle all the new information that will be coming their way following the FDA guidance to report on what happened in your trial because of COVID-19. 

New tasks like these require new skills. How will you know whether or not the personnel is ready to meet their new responsibilities? The answer is not a check-the-box activity. Instead, it’s an enriched learning experience that layers in behavioral data and aligns with the way that we know adults learn With such an approach, you will improve performance and increase confidence, knowledge, and mastery across your teamYou will also generate the data that will show you both where you need to do more and where you are ready to go. 

Modernizing your approach to educating and assessing your clinical trial staff will elevate every aspect of your staff’s performance, and go a long way toward reducing the risk of error, misstep, and even failure. 

Learn how ArcheMedX can help you make it happen through our advanced approach to training and assessing site staff.   

It’s Time to Insist on Knowing More about Your Clinical Trial Operations

When discussing how they manage clinical trial staff, industry veterans have often told us that they get the best sense of the readiness of their teams by spending some time in the same room with them, looking them in the eye. Experienced managers will say this allows them to get a gut feeling for whether a team will perform well or not, and that’s good enough for them.  

Of course meetings like that are largely off the table now. Even the most experienced and intuitive managers need a new approach. They need to tap into new sources of data for assessing team readiness and performance. 

The knee jerk reaction in times like these could be to bombard clinical trial staff with virtual meetings, emails, and phone calls aimed at strengthening communications — and mitigating managers’ concerns. But that approach heaps more work and stress on people who are already short on time. We need to be more thoughtful and purposeful about the way we share information and assess preparedness, or risk making a challenging situation worse.  


Our Problems Are Pre-existing

The rules and requirements of communication have changed since the advent of COVID-19, but there are pre-existing problems with the way we approach educating and assessing clinical trial teams:  

  • We have assumed people are properly prepared simply because they read some documents, viewed a few presentations, and checked some boxes 
  • We have ignored the fact that one-size-fits-all training overlooks the unique strengths and weaknesses AND needs of individual members of a study or site team 
  • We have wasted valuable time and resources by treating all sites the same, rather than applying time and resources strategically where they are needed most 
  • We have overlooked the operational value of the data and insights more effective training and assessments can provide 

Consider this, too:  Even in normal times, running a clinical trial involves so much change and so many updates that it is a challenge to make sure that all sites are adequately prepared at all times. But now, as we struggle to keep up with the increasing pressures exerted by the COVID-19 pandemic, there are far more changes that we and our site staff must handle. 

The FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency includes mention of many of these changes: Alternative methods for the safety assessment of patients might be implemented, protocols most likely must be amended, informed consents may need to be updated, alternative administration of product might be required, etc., etc. 

In the face of so much change and with so much at stake, we need to be able to identify and address risk before protocol deviations mount and critical data is lostFortunately, the very challenges presented by the pandemic can serve as a catalyst to drive remote staff and sites to embrace new tools and approaches. 

 


Our Solutions Are at Hand

Let’s revisit each of the problems listed above:

1. We have assumed people are properly prepared simply because they read some documents, viewed a few presentations, and checked some boxes.

There is no need to accept so much on faith these days. The technology exists that allows you to know how much time individuals spend in reviewing documents, how engaged they are through the process, and how much information they successfully absorb.

2. We have ignored the fact that one-size-fits-all training overlooks the unique strengths and weaknesses of individuals. 

Once you are aware of the unique strengths and weaknesses of individual sites or staff members, you can focus your resources on addressing specific problems in targeted ways. And, having identified high-performing individuals, you will have the option of assigning them to the most challenging roles and responsibilities.  

3. We have wasted valuable time and resources by treating all sites the same, rather than applying our time and resources strategically. 

When we deploy resources without knowing exactly who needs what support or monitoring, some get too little and some get too much. In both cases, time and money are wasted. 

4. We have overlooked the operational value of the data and insights more effective training and assessments can provide 

This is apparent in the discussion of the three previous points, but there’s more to it, as well: The ability to more precisely understand the impact of the training you provide — the effectiveness of which is measured in detail — gives an organization the insights required to be more efficient, more agile, and more productive, no matter what demands are placed on it. 

Now, and for the foreseeable future, this is power worth pursuing.