Author: Kelly Ritch

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. 

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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 we at 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. 

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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.

Today’s New Reality in Clinical Trial Readiness

We’ve talked about clinical trial readiness repeatedly in this space. Probably we all, as an industry, have a good sense of what that means — or what it used to mean. The definition has acquired a whole new dimension in recent daysFor example, this post was originally planned to be about theoretical subset of sites that have access to plenty of patients, but are not in a sufficient state of readiness to see and treat those patients properly. Today, with a pandemic raging, the more common problem is likely to be that most non-essential patient visits have been canceled and sites are consumed with COVID-19 preparations and response. 

What does “clinical trial readiness” look like then in this new world? And, what must we do to be ready to successfully operate a clinical trial today? 

The fact is that any trial that will be able to continue and be successful under the current circumstances will need to have a significant virtual component. That’s one consideration, and the shift to virtual trials has been discussed by many in recent days, but there are other implications that must be addressed: The standard of care is rapidly changing. Supply chains are slowed or blocked. Patients may not be able to receive shipments of investigational product. There are also education, safety, monitoring, and data reporting challenges to resolve 

You and your team and your sites must change accordingly to meet each of these challenges. 

Things You Need to Know

How do you prepare and evaluate the readiness of your teams, your sites, and your patients to move forward under this new model? 

  • If a trial is underway, should you pause it? Speed it up? Shut it down? 
  • Which of your sites will be able to move forward and which won’t? 
  • Which procedures can be accomplished at home or by call centers and how do you quickly prepare the staff to ensure patient safety and minimize missing data? 
  • How do you prepare team members to take on new roles and acquire necessary new skills? 
  • What patient education is necessary to ensure patients’ safety in this new paradigm? 

How can you get the answers to these important questions? We can assist you with that.

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The Ways in Which We Can Help

Like many of our colleagues across the industry, our team at ArcheMedX has been working overtime to develop the tools researchers and healthcare providers need to continue moving their work forward in these challenging times.  

  • We have made our platform available to healthcare and life science partners to deliver COVID-19 related education and training free of charge (Learn more about the offer here) 
  • We have collaborated with the Johns Hopkins School of Medicine, DKBMed, the Post Graduate Institute of Medical Education, and FreeCME to develop and distribute our first COVID-19 education and training experience to frontline healthcare workers (Access this free education here) 
  • And, we are rapidly preparing new solutions to address today’s acute readiness challenges.  

In the coming days, we will release Rapid Readiness Assessment offering, a tool designed to quickly give you the answers to how prepared your staff, sites, and patients really are to safely conduct a study in this challenging environment. 

What You Can Do Right Now

In the meanwhile, know that there is already a great deal ArcheMedX can offer you in terms of identifying the important strengths and critical weaknesses of your staff and trial sites. If you would like to discuss your particular situation, we invite you to schedule a free, no-obligation consultation with a member of our senior leadership team.  

As always, we are here and committed to helping.  

Interview: One ClinOps Leader Tells His Story on Site Preparedness, and Offers the Industry Some Advice

We recently spoke with Kevin M. Crawfordhead of clinical operations at Tenax Therapeutics, a specialty pharmaceutical company based in Morrisville, North Carolina, that focuses on identifying, developing, and commercializing products to address cardiovascular and pulmonary diseasesWe wanted to share these excerpts from the conversation: 

ArcheMedX: 

You’ve talked about the importance of telling your story. Can you expound on that? 

 

Crawford: 

At Tenax therapeuticswe’re a small company. There are 10 of us. This — levosimendan — is our product. This is what we want to do. There’s a story behind us and about how we got here. That’s an interesting story to investors, investigators, and site staff, and it includes important lessons we’ve learned up to this point in our clinical development. Specific to our current trial, an example might be, “We found this problem with ordering this drug at institutional pharmaciesHere’s the background. Here’s how to overcome it. Or, “Here’s a suggested process for designing your day when performing a right heart catheterization, followed by a 24- hour infusion, followed by another right heart catheterization, so that we have standard results across 15 sites. We don’t sit back, write a protocol, and then expect the data to come in at the end of the day. We’re continually out there creating the messages for, and telling the story of, our study.  

 

ArcheMedX: 

So, you value taking the time to do the ongoing communicationsto commit to that? 

 

Crawford: 

Yes. These investigators don’t have a lot of time, but they’re keenly interested in what we’re doing. So we give them the information in a style that is appropriate for them. I don’t want to unnecessarily call them every week and talk for half hour. Especially if that’s not the way they want to receive information. We design appropriate messaging for each investigator by getting information into a platform that fits. It might be four or five slides, a five-minute (or less) phone call, an email, or even a text. We also embrace technology and record training sessions that can be reviewed at a later date, thus further standardizing our messaging and story around the study.  

 

ArcheMedX: 

Do you find everybody receptive to your continual input?  

 

Crawford: 

It’s a fair question. I have an investigator whom I can text right now — leading cardiologist —and he would text me back. But I have another one who would not. So it’s a style thing for investigators and study coordinators. Do they like email? Do they prefer the phoneDo they like textsSometimes you just go face to face, share some coffee. It depends. 

 

ArcheMedX: 

Do you often find problems with the performance of your sites? 

 

Crawford: 

The thing is that we sometimes have sites that are willing, but not prepared. A site might sayWe can enroll 10 patients.”  But they’re not prepared to do it. Or a vendor will say“We can get this study started up in this timeframe. But they’re not prepared to do it. That creates challenges.  

 

ArcheMedX: 

How do you know whether a site is prepared or not? 

 

Crawford: 

A lot of times, it’s just listening. There are telltale signs, key performance indicators of things getting dropped. During a meeting, do people seem to comprehend the project or the timelines or the cost? If you’re dealing with a vendor, are meeting minutes coming back that express their understanding? Was previous enrollment good over time? There are plenty of different ways to assess, but a lot of times it just has to do with just picking up the phone and asking, “How are things goingWhat can we do to improve? Anything we can help you with?”  

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ArcheMedX: 

Are you checking in or assessing still as the trial continues?  

 

Crawford: 

I think a level of due diligence is always appropriate. And I definitely have been caught off guardtrusted too much that something was being taken care of when it wasn’t 

 

ArcheMedX: 

Do you have any plans for changing the way you go about interacting with or preparing your sites? 

 

Crawford: 

I have plenty of ideas: Providing more visual tools to sites, for example, short videoor something else to help them visualize what needs to happen on the study. Maybe it’s a training video. Maybe it’s Doodle. Patients, too, could benefit. They read a consent form. It includes a lot of information. Usually it’s written way above the eighthgrade reading level. Using apps, art, and technology, we could help people better understand the study as a whole. 

 

ArcheMedX: 

Anything else you’d like to share? 

 

Crawford: 

I’d like to say a word about leadership and the need for leaders to take risks and be willing to speak up. We all have that little voice in our head telling us that we’re not good enough, that we better not raise our hand, for fear of being wrongBut that’s how things move forward. That’s how innovation is createdI’d like for us, collectively, to have the boldness and audacity to speak up and to take charge, take ownership, be accountable, and move the ball forward, because we all need it. You don’t have to wait for permission to be a leader.  

Another comment on moving forward: Our industry in general tendto attract a certain type of professional for whom perfection is the ideal. think that may limit innovation. Walways want to replicate what we did before: This study was successso we should do the next the same way. This protocol template works, so we’re never going to change it. Our consent is great. We’ve never gotten a 483, so let’s use that consent form again. Nobody wants to stick their neck out and be rewarded with an FDA audit. So there’s that challenge in the industry. Being a perfectionist is not a bad thing, but I hope we can strive for being exceptional while being innovative at the same time. 

ArcheMedX:

As Kevin said, even those sites that are fully willing might not be prepared to conduct studies, particularly in challenging fields like cardiology. Today’s industry leaders need to be communicative and innovative to succeed. 

Are You About to Launch a Clinical Trial? Pump Your Brakes.

As the coronavirus continues to spread and dominate the media, we are inundated with advice on what to do: How to boost our immunity, how to conduct business, how to wash our hands. If you are about to launch a clinical trial or initiate additional sites, consider this advice: press pause.

(Unless, of course, you’re launching a coronavirus trial.)

We understand that you are under a great deal of pressure. There are millions of dollars at stake. Scores of people have been mobilized. Senior management is watching. Investors are anxiously waiting. The stakes are extraordinarily high. All the more reason to seriously consider a purposeful delay.

There’s significant risk involved in clinical trials in the best of times, and today we are far afield from the best of times. Not only are we in the midst of a pandemic, but the effects of that pandemic are still unfolding. It’s clear the virus is spreading, but where, when, and who will be most impacted remains clouded in uncertainty.

What we do know is that work and life are already being disrupted: Logistical challenges around shipping supplies are growing. Patients are increasingly less willing and able to get to and complete visits. The industry is scrambling to establish new and broader remote oversight strategies that a few short months ago were considered nice to have, and have now become essential.

Launching or expanding a clinical trial at this time means deploying valuable resources into a great unknown.

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Here at ArcheMedX, we are following our own advice. We are pausing to ensure our business continuity plans fully support the potential scenarios we are facing, including a fully remote workforce. We are assessing for any single points of failure that require additional documentation or back-up resources to be prepared. For our customers, instead of storming full-speed ahead with new initiatives and launches, we are pausing to tighten up data integrations to ensure the broadest and most seamless access to our platform. And, we are polishing data reports and dashboards to ensure operational leaders have the fastest and clearest signals to more quickly make decisions.

In our current rapidly changing, highly-likely-to-be-disrupted environment, we encourage reflection before action. Pause and consider how you might put a more flexible, data-driven, risk-based model in place, a model that accomplishes a lot more work in what is often called a centralized way, but will now be more remote and dispersed. Consider digital solutions that push data and consumable insights into the right hands at the right time and give you signals about how your project team and site staff resources are doing before issues multiply. Ultimately, these efforts will save you a great deal of time and money going forward, and prepare you well for whatever new challenges may be in your future.

Putting the brakes on a clinical trial is certainly a big move to make. It won’t be easy and it won’t be painless, but if your ultimate goal is for your trial to succeed, pause it.

Interview: Managing Studies In A Rapidly Changing Treatment Environment

We recently spoke with Joann Peters, Vice President Clinical Operations at Geneos Therapeutics, a biotech focused on developing personalized, tumor-targeted immunotherapies. The company is based in Plymouth Meeting, PA. We wanted to share these excerpts from the conversation:

ArcheMedX:

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

Peters:

One of the biggest challenges is creating a protocol that can be executed expeditiously and still be relevant in a rapidly changing treatment environment. For example, a treatment is  approved for second-line treatment today, but potentially changing to first-line treatment. If a study is targeting patients on the current approved regimens and there are changes to institution formularies based on newly approved drugs, sponsors need to be agile enough to change their protocols in order to remain relevant. That’s no small feat. Ongoing discussions with investigators or advisory panels, revisions to the IND, additional regulatory approvals, revised study plans, and training are just a few things that are impacted and must be addressed in a short period of time.

Another challenge is timely enrollment. Competing studies, staffing constraints, and capturing the interest of treating physicians can present obstacles to enrollment. Conducting a thorough feasibility study and talking directly with the PI and study staff will help alleviate these constraints.

Having a team that believes in your product and protocols that don’t deviate much from standard of care can support study sites and enrollment. For those of us working in oncology, our patients may be too sick to qualify for a study, thereby reducing the patient pool.

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ArcheMedX:

How do you assess the preparedness of the members of a clinical trial team before study startup?

Peters:

For a new study team, review of CVs is essential.  The CV provides information like longevity in a role and the company; it also provides an overview of therapeutic experience and expertise.  If possible, we may interview team members to ensure they are a good fit.  Ultimately, we rely on the project manager to ensure collaboration and preparedness of the team. And, we consider a face-to-face study kick off meeting to be essential for developing a cohesive team.

A concern in our industry is that many teams do a great job on the initial training, but after that, never think about it again. We need to make sure that people have the right knowledge and skills not only on day one, but that they maintain that knowledge and those skills.

A concern in our industry is that many teams do a great job on the initial training, but after that, never think about it again. We need to make sure that people have the right knowledge and skills not only on day one, but that they maintain that knowledge and those skills.

ArcheMedX:

Do you continue to assess the preparedness of the team and site staff as the trial goes on?

 Peters:

Study teams continue to be assessed by milestones achieved, communication of potential issues and mitigation, and during regular teleconferences.  There are team members that work behind the scenes; however, they can be assessed similarly based on the quality of data outputs and feedback from peers and investigative sites.

 ArcheMedX:

In a perfect world, what might you do differently in regard to preparing and assessing clinical trial staff?

Peters:

I’d like to include periodic assessments to ensure the study team and trial staff understand the protocol. I’d also like to conduct a face-to-face meeting prior to enrollment. An investigator meeting is a good example of this, however not all studies have an investigator meeting.

I believe this would help ensure that there is a good understanding of the study and goals for execution. The kickoff meeting is more of an introduction to the study team. By contrast, the meeting prior to enrollment requires much more knowledge around study execution.

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ArcheMedX:

Do you have any immediate plans for revising the way you manage clinical trials?

Peters:

We always want to encourage openness with our CRO and study sites and ensure accountability between the parties.

ArcheMedX:

What changes, if any, do you foresee in clinical trial operations in the near future?

Peters:

Personalized medicine presents a need to be more hands on with our teams and study sites.  Timing of the medication becoming available and when the patient needs to wash out of current drug regimens, for example, must be carefully managed. Collaboration and a good rapport with the sponsor, CRO, manufacturer, and study site will be increasingly important for success. In fact, it’s key. I’ve managed all my projects in this manner and the results have been amazing.

Collaboration and a good rapport with the sponsor, CRO, manufacturer, and study site will be increasingly important for success. In fact, it’s key. I’ve managed all my projects in this manner and the results have been amazing.

ArcheMedX:

As Joann emphasized, sponsors and sites must be better prepared to conduct studies today in a rapidly changing treatment environment. This requires the ability to implement more agile protocol modifications, to ensure project teams and site personnel understand and can implement the changes, and to periodically assess staff and site readiness to recognize risks sooner. The more complex or challenging the study, particularly in oncology, the greater the need to quickly identify which study changes or readiness issues are well understood and which require additional clarification or remediation before key milestones are missed.

[Interview] Increasing Study Confidence In the Eyes of a CRO Executive

We recently talked with Mike Keens, Chief Operating Officer at Firma Clinical Research, a clinical research service provider specializing in patient-focused trial designs, often with at-home visit support. We wanted to share these excerpts from the conversation:

ArcheMedX:

What do you see as the biggest or most common challenges to preparation for, or conduct of, a clinical trial?

Keens:

A former CEO of Amgen used to say you need to have a shared reality. So when you’re getting things up and running in a clinical trial, if you haven’t taken the time to get everybody together and make sure they’re all operating under the same assumptions, things will start to go wrong.

You’ve been talking about the project ever since the RFP, you did a bid defense a few months ago, and since then, a bunch of things have changed. Take the time to review everything and making sure that you’re aligned.

Unfortunately, most people feel they don’t need this. They think, “We already know what’s going on.” But you would be surprised what you learn when you get everybody together.

ArcheMedX:

What is your approach to training clinical trial staff?

Keens:

We have robust training for each protocol. Also, because we’re directly supporting patients in the home, we routinely partner with advocacy organizations so that not only are we training on the protocol requirements, but we also train staff on the patients. That involves getting information from the advocacy groups on subjects like what the patients’ lives are like, what situations our team members are likely to encounter, and how we can make sure that the patients have a good experience.

A concern in our industry is that many teams do a great job on the initial training, but after that, never think about it again. We need to make sure that people have the right knowledge and skills not only on day one, but that they maintain that knowledge and those skills.

We need to make sure that people have the right knowledge and skills not only on day one, but that they maintain that knowledge and those skills.

ArcheMedX:

As a study goes on, inevitably there is staff turnover. How do you get new people up to speed?

Keens:

The original training materials are always helpful. Also, we keep a running log of decision making and the rationale for any changes that have been implemented since study start. I’m sure other groups have something similar, but the challenge is more than getting somebody up and running on the initial information. It’s how do you get someone educated on the 18-month history of the trial that they are joining without having them feel it will take 18 months to learn it?

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ArcheMedX:

What would you like to do differently when it comes to preparing and assessing staff?

Keens:

I would really like a tool or system that, with very little manual input, can do staff training, but can also continue to assess how people are doing and gives us ongoing confidence that a team is on track. Consider that when you get your driver’s license, that’s not the end. Every once and awhile, you have to go back to the DMV and get your license renewed.

Anything that might provide oversight and data would be helpful. I mean, I’d love to be able to share that information with sponsors and say, “Hey, here’s where we are. You don’t even need to ask how things are going.”

I would really like a tool or system that, with very little manual input, can do staff training, but can also continue to assess how people are doing and gives us ongoing confidence that a team is on track.

ArcheMedX:

Do you have any particular plans for the year ahead? Anything new you’ll be implementing?

Keens:

We’re spending a lot of time working on direct-to-patient feedback — or direct-from-patient feedback. It’s not something widely done in the industry, which I understand because of privacy concerns, but we’re reaching out to patients to schedule visits, going to their locations to get feedback. I think the next project will be to work on how we can better implement training for nurses and phlebotomists.

ArcheMedX:

As Mike astutely observes, it is critical to ensure that all persons involved in a trial are prepared not only on day one, but that they remain highly capable throughout the duration of the study. Equally important is the need to continually assess the readiness and performance of all persons to provide confidence the study is on the right track.

[Interview] Keeping It Personal: CRO Executive Uncovers the Value of Analytics in the Management of Clinical Trials

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

Check back regularly for more.

We recently talked with Suzanne Kincaid, Chief Operating Officer at Aperio Clinical Outcomes, a CRO based in the Research Triangle Park area of North Carolina. We wanted to share these excerpts from the conversation:

ArcheMedX:

What do you find are the biggest concerns for teams during the preparation or conduct of a clinical trial?

Kincaid:

It is so important for the sponsor to have a clear vision of what they want to accomplish.  Ideally the protocol outline, inclusion/exclusion criteria, and study procedures are set.  Then, once the sponsor has started developing a relationship with a potential vendor, it’s important to share clear expectations between the CRO and the sponsor — understanding, for example, what they want their day-to-day interactions to look like.

We are truly site centric.  We design everything from the start with the site in mind, and consider how we can make this a good experience for them.  Key to this is clear communication. Sites understand things can change.  Once you start going out to sites, it’s important to have a solid study design — especially in regard to the inclusion/exclusion criteria. The sponsor also must be clear on the procedures and equipment that will be required to conduct the study. If any of that changes while the sponsor is in the planning stage, it must be communicated back to the sites what the changes are — and the sites must let the sponsor know if they can still meet the commitment. You don’t want any surprises at the initiation visit with the site.

ArcheMedX:

What sort of surprises?

Kincaid:

You could find that a site no longer has the right patient population to offer you if the inclusion/exclusion criteria has changed or if you have introduced procedures that vary so much from the standard of care at the site that the site is unable to participate. Alternatively, there may be hospital policy that prevents the site from doing certain things that you now require in your clinical trial. Sponsors don’t always think about how tweaking seemingly small things in the protocol can impact the site.

ArcheMedX:

Once you’ve established the relationship and you’re off and running, how do you get site staff prepared?

Kincaid:

We like to do that on a just-in-time basis, because the closer the site is to opening for enrollment, the better. If they’re not able to enroll a patient right away, they will lose a lot of the learning. Beyond that, it’s about face-to-face time, assessing their engagement, making sure they have everything they will need, collaboration and commitment, person-to-person.

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ArcheMedX:

Are there any tools you have tried or used as an alternative for face-to-face meetings?

Kincaid:

We have developed tools for site training that cross-check who the site personnel are, which activities have been delegated to them by the principal investigator, and whether they are qualified. And we have a matrix for what they need to be trained on versus the tasks they will be doing. We build this prior to the site initiation visit, go over it with the staff during that initiation, and then check in frequently throughout the life of the study to make sure everyone who’s conducting the study is appropriately qualified and has received proper training.

ArcheMedX:

How often do you check in on staff over the course of the study? When you do check in, do you find the staff are still measuring up?

Kincaid:

That is a large challenge in clinical trials, especially at bigger centers that tend to have a lot of staff turnover. You’re not always aware of staffing changes when you’re not on site. We try to keep an eye on it with requests such as access to the EDC system for new people, and use that as a trigger.  We use our robust set of tools for reconciling the delegation log and training documentation and review this at every visit to the site.  We want to make sure all new study team members at the site have everything they need to be successful.

ArcheMedX:

How do you train the new people?

Kincaid:

We believe it is best to educate people onsite. When time doesn’t allow for that, we hop on a web conference with them. There’s still very much a human element to it.

ArcheMedX:

How might you like to improve on this?

Kincaid:

We have a lot of very helpful and efficient systems, but unfortunately every company has different systems, and I think it can be difficult for the sites. CROs have different systems, sponsors have different systems, and a site that’s conducting multiple trials is then using multiple systems, so it can be very burdensome for the sites.

I wish the industry could adopt a best-of-the best system and all go with it. But then, what would that do to our competitive marketplace?

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ArcheMedX:

Do you have any immediate plans to revise any of your processes?

Kincaid:

In 2020, our focus is going to be on more analytics and centralized monitoring. It doesn’t eliminate the need for on-site monitors; we will just use them more for the skills and strengths they have rather than having very highly skilled professionals checking transcriptions.

ArcheMedX:

Anything else you’d like to share with us?

Kincaid:

I’ve seen a lot of changes in clinical trials in the past 25 years, and I’m really excited about the advances and the technology enabling them, but the human aspect – the relationships, the experience, and the job knowledge – can’t be overlooked.

Something that’s disappointing for me is that despite all our technology, we still see egregious mistakes at some companies. In the site audit consulting work we do, we see sites grossly over-enroll beyond what they were supposed to enroll in a study. We see missing records . . . It disappoints me that this can still happen in 2020.  We are excited about the impact clinical trial analytics will have on the industry, the visibility it will provide to all companies, and the early warning signals it will provide.

ArcheMedX:

We share Suzanne’s excitement about the role technology, especially the use of predictive analytics, can play in advancing clinical research and avoiding unpleasant surprises. As the industry accelerates adoption of new data models and predictive tools, the timely insights they provide can inform clinical trial leaders of potential risks and challenges sooner than they might otherwise identify. Faster recognition of critical issues and improved decision making will help all of us avert the big mistakes that often delay and derail critical studies.