For those beginning studies on OC4, we’re pleased to offer these video training sessions, “bridging” your knowledge of OC3 with the skills needed to make the most of the current release.
For the last several months, we’ve asked professionals with data management responsibilities to evaluate their current processes for accomplishing critical tasks. We then asked them to rank three of these tasks as their first, second, and third priorities.
Specifically, we each respondent to consider these EDC-related tasks…
… and to characterize their process for each one as either…
The data below reflects the responses of data managers (n=25), study and program leads ( n=13), IT/database professionals (n=6), and a CRA. To reduce bias, we did not include responses of known OpenClinica users.
What did we learn? Data managers and their colleagues are getting the job done (no surprise there) and are generally content with the way they’re doing it. But current processes usually fall short of ideal. How do your experiences compare?
Click to see enlarge version
More and more often, that’s the question motivating today’s most innovative research. Whether it’s an RCT with a biomarker cohort or an observational study based on real-world evidence, we’re seeing the “data funnel” widen to encompass much more about the participant than their diagnosis. Genomic medicine is just one example. Factors including phenotypical traits, diet, and lifestyle, among others, are all counting for more in studies that seek to match the right therapy with the right patient.
This year’s theme is a recognition of this important new paradigm. But it’s not meant to constrain. How are you adapting to the complexity of new and expanding data types? How do we make the tools of data management as personal and precise as the results we’re seeking?
We’ll explore these questions and more as data gets personal at OC18!
For the second year in a row, we’re looking forward to hosting a panel session at the Society for Clinical Data Management Annual Conference. Last year, we gathered four experts, including our own Ben Baumann, for a panel on ePRO. This year, we’ll turn our sights on eConsent. Our panelists represent a “who’s who” of seasoned professionals in this area. Learn who they are and read all about the issues they’ll discuss below. First, take a listen as one panelist, project manager and clinical trial educator Brittany Stark, walks us through the advantages of adopting eConsent and tells us why review boards are likely to embrace it as trial complexity grows.
Brittany on eConsent
Hello and welcome from OpenClinica. My name is Bryan Farrow and I’m joined today by my colleague, project manager Brittany Stark. Brittany, may I ask you a few questions about e-consent, the topic of our panel at this year’s SCDM conference?
Let’s start by having you tell us about your clinical research career, especially as it pertains to consent.
Working in the professional services department here in OpenClinica, we get a variety of projects invlving eConsent. Prior to joining OpenClinica, I worked at Beth Israel Deaconess Medical Center in their Cancer Clinical Trials Office, where I worked as a clinical research coordinator, later in the regulatory affairs department, and then as a clinical trial staff educator, all involving different aspects of either the education of informed consent documentation of collection.
Great, thank you. For the sake of brevity, I’ll assume our audience is familiar with the basics of econsent and steer our conversation toward the advantages and obstacles associated with it. Let’s start with the obstacles. A common one is the anticipated resistance of review boards. Brittany, why might an IRB resist econsent?
Well they’re used to paper-based methods with an established precedent.
Fair enough, but why should they consider embracing eConsent?
eConsent has the potential to enhance patient understanding by means of an eLearning experience that is engaging and informative. This can be achieved through the use of graphics, interactive tutorials, videos, or even quizzes tapping into their understanding of the study.
An eConsent form can guide a patient through this experience, step by step, only presenting a signature box at the end of these exercises. Paper-based methods, on the other hand, can allow for corners to be cut.
All that sounds terrific. So why are sponsors sometimes reluctant to adopt econsent?
Here again, there’s the weight of tradition. They may also anticipant resistance from local IRBs, which in their eyes could cause delays.
Those are legitimate concerns. What might you say to a sponsor to persuade them to take another look at eConsent?
Sponsor’s shouldn’t assume that an IRB will reject this method. Simply put, an IRB’s priority is patient safety. Patient safety starts with their understanding of the trial and all of the inherent risks involved. As I mentioned before, this is where eConsent can offer more protection through a step-by-step online experience.
Sponsors can achieve tremendous time and cost savings. eConsent eliminates the costs involved in chasing that paper trail, reducing the research team’s time involved in the consent process.
eConsent can also provide real time recruitment rates to study sponsors. This is very important when studies cannot risk going over set enrollment goals. Sponsors can also more accurately project future recruitment with this kind of real time reporting.
Based on everything you said, do you think the future of eConsent looks bright?
Absolutely, and I look forward to talking about this more during our panel.
“More Than Checking Boxes: Integrating Electronic Informed Consent in a Compliant and Ethical Way”
a panel session as part of the 2018 SCDM Annual Conference
Tuesday, September 25, 2017 from 11:15am to 12:15pm
Hyatt Regency Bellevue, Seattle
Cal Collins CEO, OpenClinica
John Wilbanks, Sage Bionetworks
Kristen Warren, DxTerity
Kevin Johnson, Intermountain Heart Institute
Brittany Stark, OpenClinica
Vincent Miller, Duke Clinical Research Institute
Sandra Sather, CRF Health
Regulatory authorities have been clear that Informed Consent is a multifaceted process that goes far beyond obtaining a signature. Genuine consent involves providing potential participants with adequate information about the research to allow for an informed decision to participate, facilitating and verifying comprehension of the information, and allowing adequate opportunity for questions and consideration. The process often continues after enrollment. Investigators are frequently obligated to provide additional information to participants as the research progresses, and even obtained informed re-consent.
Electronic informed consent (e-Consent) must accommodate all these requirements. Done well, e-Consent can maximize patient understanding, engage non-English speakers with multilingual tools, improve documentation and reporting, and standardize the consent process across sites, all while reducing cost and administrative burden. Attendees of this session will learn how to determine the suitability of e-Consent in light of a study’s setting, participant profile, and indication (among other attributes), as well as the best way to adapt the principles of fully informed consent in its usual, paper-based context to one where the process is electronic.
The first major update to OC4 went live early today, with new features that extend your study’s flexibility so much that we wanted to call them out in this post.
Common events are not associated with a visit date, and do not occur at a scheduled time-point. Instead, they are incidental events that often recur, such as adverse events and concomitant medications. This update makes it easy to include common events in your study. You can include multiple forms in a common event, which allows each form to repeat independently within the event.
Study designers can even select key fields in the forms to display those field values on the (new, UX-optimized) Subject Details page, allowing users to view form data without having to open the form.
You now have several distinct widgets for collecting files.
Image, audio, and video widgets allow users to upload these file types, which may then be viewed or played within the browser window.
We have also added a generic file widget for uploads of any type. (However, these files do not support a preview in the browser window.)
Any uploaded file may be downloaded from within the form.
Used judiciously, free text fields can enrich the data collected in a study. So just image what free drawing can do. This latest update supports:
The annotate and draw widgets allow the user to undo individually added lines.
A new feature allows administrators to view a directory of all users created for at least one test or production environment in their instance. Each user record indicates:
An edit button allows an administrator to update a user’s first name, last name, phone number, e-mail address, organization, or user type (i.e., attributes that are independent of any one study or environment). A deactivate button removes access for that user to any study environment to which they had been assigned. For deactivated users, a Reactivate button restores all access.
It’s that foresight which, in the mid-1990s, has earned you membership to an international committee of your peers; a committee tasked with devising guidelines to “facilitate the mutual acceptance of clinical data” by regulatory authorities in Europe, Japan, and the United States. At least, that’s the operational goal, and a worthy one, too. You started in this business to push the best research out of silos and ivory towers and into the real world. But that mission is fraught with potential dangers. Not forty years prior, inadequate testing of an immunomodulatory drug led to the births of more than 10,000 children with limb malformations in Germany. Just three years ago, in a trial conducted by the NIH, five participants died of liver toxicity following experimental treatment for hepatitis B. Whatever standard you propose for maximizing the benefits of clinical research, it had better provide “public assurance that the rights, safety and well-being of trial subjects are protected.” After all, your committee is bound by the ethical good in its pursuit of the clinial good. You suggest calling the standard Good Clinical Practice.
Welcome to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. And welcome to 1996.
But don’t get comfortable. This is the story of GCP–more precisely, the Guideline for Good Clinical Practice–and it is headed right back to the present, with its first amendment already in force in Europe. Why did the ICH amend its original guideline? Why twenty years later? There’s no single answer, but all the best answers revolve around one theme. Just as our phones have gone on to earn a postdoc in the last 22 years, the possibilities for research have matured, too. What’s more, their modern histories are linked, with technological breakthroughs inspiring the search for clinical ones, and clinical triumphs spurring ever more capable technology. Behind that push and pull, the need to ensure safety and quality remains constant. The story of the GCP’s amendment is a story of time-honored values upheld in new ways.
In a literal sense, E6(R1) hasn’t been replaced at all. The authors of E6(R2) choose an integrated addendum format when drafting the updated guidance. The original language, with all that it mandates, remains:
The addendum text clarifies the scope and meaning of preceding terms. Twenty years ago, the word “storage” brought to mind file cabinets. Early in this millenium, we might of have pictured hard drive volumes. Today, our heads are in the cloud. But in all of these contexts, storage that is secure and accessible is a must. It’s how we achieve it that differs.
But just how do we achieve it–meaning everything from security to safety to data quality–in 2018, when so many tasks once considered part of an “honest day’s work” are now specialties of automation, algorithms, and analytics?
Not even the full sixty pages of the document provide a specific, once-and-forever answer. (As a guideline, it shouldn’t.) What E6(R2) does propose is a 21st-century mantra for maximizing safety and quality. The mantra sounds like this:
“Oversee it all. Take action on what matters.”
There are some loaded terms in this phrase. “Oversee” might translate to “maintain real-time digital access,” particularly in the case of processes occurring daily all over the world, such as eConsent. And “take action” needs to cover both proactive and corrective measures. But with those common sense glosses in mind, we could do worse than take the directive above as the crux of E6(R2). What evidence do we have for this reading? Before we look at specific clauses in R2, we can gain a strong sense of how the amendment differs from the original by looking at the frequency of key terms.
Terms like “risk-based” simply weren’t part of the vernacular in 1996, so it’s no surprise that they should make their first appearance only now. But the concept of risk is as old as modern, statistically-informed research itself. So why does the word itself occur twice as frequently in R2 as opposed to R1?
The answer is that risk is omnipresent now, not primarily in the sense of an unintended consequence, but as a factor in decision-making. How did this come to be the case? Along almost any dimension we consider–target enrollment, sources of data, self-reports–research is doing, and producing, more than it ever has. In some cases, like the breadth of genomic factors analyzed, research is doing more than we thought possible back in 1996. On the other hand, the number of hours in a day has remained disconcertingly flat (anyone working on this?). Human cognitive capacities and attentional reserves likewise remain more or less the same. Our technological capacities have grown in orders of magnitude, and that’s all good. But until self-organizing, self-monitoring trials (powered by AI) are the norm, we humans will continue to serve as the chief executives of research.
While the amendment stops shy of saying it explicitly, R2 recognizes that distributing our time and attention equally among all processes works against safety and quality. That’s because some studies are now so complex, or collect so much data, that line-by-line “box checking” not only becomes impractical, it distracts us from those risks that only become apparent on a “big data”-like view of key metrics. In other words, it’s crucial that we see the risk forest for the data element trees. That’s the message behind much of the amendment text:
From the Introduction:
From section 2, “The Principles of GCP”:
From section 5, “Sponsor”:
Does this mean less rigor in oversight? Just the opposite. The GCP amendment will require more vigilance from all parties, from sponsors and sites to CROs and vendors. It means bringing alertness and analysis to bear in order to find the boxes, not just check them. This isn’t the ICH throwing up its hands now that the “scale, complexity, and cost of clinical trials have increased.” It’s the ICH demanding that we learn, and practice, new survival skills in a new world.
So drop the Nintendo controller. Time to pick up some neural implants.
See the video now, join the webinar on March 26 or 28.
You know it better than anyone: clear, on-demand reporting is more than a “nice to have” in our field. It’s essential to conducting research that’s efficient and safe. That’s why we’re launching OpenClinica Insight. Insight makes it easy to ask questions of ALL of your clinical and operational data and visualize answers via interactive reports and dashboards.
Learn more at either of these upcoming webinars:
Monday, March 26, 8pm GMT, or
Wednesday, March 28, 8am GMT
The idea is simple, but the results are powerful: ask your questions, choose your visualizations, then return often for updated, interactive results that link you to all of the underlying data.
Our thanks to a smart, engaged audience for the lively webinar on Monday, featuring the new OpenClinica. Couldn’t tune in? Not to worry! Register here to stream it on demand.
Happy New Year!
We’re excited to start 2018 with our most significant new release in 10 years. We want to give you all the details in one info-packed hour.
On Monday, January 22nd, from 11am to 12pm EST (UCT-5), learn about the smarter way to build and publish studies, create mobile-friendly forms, and manage your data. We’ll also show you the rock solid security, compliance, performance, and reliability that comes with our cloud hosting.