DIY Study Build at 2X the Speed

OpenClinica Study Designer

Do you wish you could make the leap to build your own study within an EDC solution? Perhaps you have relied on CROs or external developers and want more control, increased speed, or better cost effectiveness. Many of our customers come to OpenClinica specifically for these reasons.

Most electronic data capture systems are not designed for the average data manager to build studies. These systems often require a high level of technical expertise from specialized clinical programmers. On the other hand, systems that data managers may find easy to use are often over simplified, lacking the necessary capability and functionality to run a trial effectively. OpenClinica gives data managers the best of both worlds: exceptional capabilities and the ability for today’s clinical data managers to deploy them in their studies.

Let’s start by taking a look at some of the key ways the OpenClinica Study Designer delivers on this promise.

Building Study Events (e.g. Visits)

Events are the building blocks of your study’s architecture. This is where your protocol foundation is visualized, eCRFs are placed, and ultimately your study calendar is set. These building blocks can’t be set in concrete however. They must allow for flexibility during adaptive trials, during early phase setup, and any potential mid-study changes or protocol amendments down the road.

The following video shows how easy it is to create and modify study events:

 

Seamlessly engage patients

The Covid-19 pandemic underscores the need to be able to carry out trials more remotely, and as a result researchers are relying more heavily on ePRO, eCOA, and eConsent. These capabilities can be seamlessly added within the OpenClinica Study Designer. In fact, 90% of our clients are incorporating this digital capability within their studies now. 

Select a single checkbox to enable an ePRO form.

Create ultra-smart eCRFs

The electronic case report form (eCRF) is the heartbeat of your study. OpenClinica eCRFs are incredibly capable and smart. Never ask the user for a value the system doesn’t already know (or can’t deduce). Real time edit checks and dynamic logic create a tactile and engaging experience. User forgot to hit the save button? No worries, OpenClinica forms automatically save your data. Whether a simple quality of life questionnaire or forms with edit checks, skip logic, and complex calculations, OpenClinica forms can have a tremendous impact on your study’s overall productivity.

Check out our Ultimate eCRF Design Guide to see some OpenClinica forms in action. All the extraordinary things these forms can do can be set-up by a clinical data manager (you don’t need to be a programmer). 

Stay tuned for a future post on the OpenClinica Form Designer and Form Library. 

Collaborate with stakeholders

The pace of building a study is heavily impacted by the ability to collaborate and iterate with your team. With OpenClinica, you can avoid the countless emails and inefficient meetings which can frustrate your team and inflate the timeline unnecessarily.

OpenClinica’s Study Designer enables real-time and asynchronous review. Invite a colleague to review a form and post comments. See updates to the study design without having to refresh your screen. Use labels and checklists to track the review and approval process and keep everyone on the same page. Increase your velocity.

One-click publish

From the Study Designer, you only need a single click to publish your study to OpenClinica’s test or production RTE (run time environment).

What you don’t see, running behind the scenes, is all of the automation, API calls, and modules associated with getting all your events, forms, definitions ready for go live. This is another example of powerful capabilities wrapped within a friendly, easy to use interface.

Publishing to your dedicated test environment, your team can perform all the training and testing required until you are ready to one-click publish to production. And don’t stress when the all too certain protocol amendments occur. You can make your study modifications quickly, whether event-based or form-based in the study designer. Rest assured, OpenClinica has fail-safe mechanisms for preserving study and data integrity.

Your stakeholders will be impressed at how you can turn around changes in hours, not not weeks.

No more long build times that bleed into study execution

No more advanced technical demands on data managers

No more wasted time in reviewing and publishing your study

See efficiency gains live – get a demo now.

Supporting RECOVERY for Covid-19

The largest randomized clinical trial for #Covid-19 treatments is making great strides in adaptively testing the treatment options for the UK and the entire world population. We are proud to support the efforts of Oxford University’s Nuffield Department of Population Health, and Nuffield Department of Medicine, with capturing the critical trial data and enabling the flexibility of the adaptive platform method.

The trial is being conducted in over 170 NHS hospital sites across the UK with over 10,000 participants to date. Patients who have been admitted to hospital with COVID-19 are invited to take part. The Chief Medical Officers of England, Wales, Scotland and Northern Ireland, and the NHS Medical Director are actively encouraging enrollment in this study and other major studies in the UK.

The trial is being coordinated by researchers at the University of Oxford, led by Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine and Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health.

Trial Treatments

  • Lopinavir-Ritonavir (commonly used to treat HIV)
  • Low-dose Dexamethasone (a type of steroid, which is used in a range of conditions typically to reduce inflammation).
  • Hydroxychloroquine (related to an anti-malarial drug)
  • Azithromycin (a commonly used antibiotic)
  • Tocilizumab (an anti-inflammatory treatment given by injection)

Trial Design

RECOVERY has an “adaptive” design, with data analyzed on a rolling basis so that any beneficial treatments can be identified as soon as possible and ineffective ones dropped from the trial.

“One of the biggest challenges with trial setup was developing the randomization capabilities, which we built in-house,” said Andrew King, Head of Trials Programming. There are several arms that are included in this study with the need for flexibility to enable quick treatment additions and modifications. There is also a second randomization for tocilizumab and standard of care. The randomization data is easily ingested into the randomization forms within OpenClinica, through the API.

“Building the study and the forms within OpenClinica was very straightforward and quick,” according to David Murray, Senior Trials Programmer. Site staff enter the trial data into the forms, primarily at the 28 day mark. “Another challenge operationally was training the over 4,000 site personnel on the randomization protocols and the EDC system. We found the training for OpenClinica’s EDC to be inconsequential in the process,” said David Murray.

For regular news, updates, and findings, be sure to visit the RECOVERY site. We continue to support many organizations in their efforts to research and ultimately discover effective and safe vaccines and therapies.

Feel free to contact us with any question on how we can help with your clinical studies.

 

OpenClinica’s Response to the Coronavirus

At OpenClinica, we are working hard to ensure our users, especially those working on COVID-19 projects, are fully supported with the tools, service, and performance you’ve come to depend on from OpenClinica.  Our team has adjusted seamlessly to a remote-work model and we are fully operational. We have in place business continuity procedures that all our staff are trained on yearly. These procedures ensure that we can continue to provide you with the service you require in a number of disaster recovery situations, including pandemics, and include procedures for remote work. We are following the guidance of the CDC as well as state and local public health officials and emphasizing that our employees do the same.

We consider it a privilege to be supporting multiple, highly consequential COVID-19 related research projects. Some of these have already come online and others will in the coming weeks/months. At the same time, we recognize the stress that the pandemic environment is placing on other research studies. Our products include capabilities to help transition many research activities that formerly were done in-person to fully electronic and remote activities. We are helping customers use tools like OpenClinica Participate to increase participant engagement via mobile and web communication, in many cases from recruitment all the way through study completion. More and more are adding source document upload fields to their studies to support remote monitoring. OpenClinica Insight is proving to be a highly useful tool to review clinical data and operational metrics in real time, and to deliver automated notifications and alerts where and when they’re needed most.

We are committed to ensuring the health and safety of our customers and staff and to making sure our products and services are fully available to you. Our solutions are continuing to be delivered with the same levels of uptime, performance, and support that you have come to expect from OpenClinica. Our love and gratitude go out to the true heroes, all the healthcare providers on the front lines of this crisis.

We value your trust and are committed to continuing to exceed your expectations. Please reach out to us if you have any questions or if there is anything you need. We are ready to help!

 

To counter bias, counterbalance

wooden scale with dice in background
On a scale from 1 to 10, with 10 representing utmost importance, how important is a healthy diet to you?

Do you have your answer? If so, I’ve got another question.

Which appeals to you more, a cozy bed or a luxurious meal?

Yeah, me too.

These are hardly clinical questions, but as far as survey items go, they’re instructive examples. The wording for each is clear. The response options are distinct. The structures, a scale and a multiple choice, are familiar. But if we want valid answers to these questions, we’ve got some work to do.

When designing a survey, it’s easy to overlook the effects its format could have on the responses. But those effects are potent sources of bias. In the example above, the first question primes you to think about diet and health. In doing so, it stacks the deck against the “luxurious meal” response in the following question. But the trouble doesn’t end there. Although “bed” and “meal” make for a short list, one of them appears before the other. The primacy effect–the tendency of a respondent to choose the first in a list of possible responses, regardless of question content–puts “luxurious meal” at a further disadvantage.

The good news is that surveyors (and data managers) have tools to mitigate these biases. Modern EDC allows you to systematically vary both question and response option order, either by randomly selecting from a set of all possible permutations, or rotating through a block of permutations one participant at a time. The practice, called counterbalancing, guards against unwanted order effects.

But it isn’t a cure all. Consider the practice of rotating through all permutations of your response options. No matter how a set of response options are ordered, one of them has to be placed first. The primacy effect, then, isn’t so much as diminished as it is distributed among all the response options. To illustrate, suppose we ask the two questions above in alternating order to 1,000 respondents, all of whom responded. In the end, you may discover that 82% of the “bed or meal” respondents chose “bed,” while only 16% of the “meal or bed” respondents chose “bed.” Results like these ought to make you suspicious. If there’s no reason to believe the two cohorts differ (apart from the phrasing of the question posed to them), it’s premature to conclude that the population is split almost evenly along their preferences. The majority of the respondents selected whichever option they encountered first, so it’s much more likely that you’ve confirmed the power of the primacy bias.

The same caveat applies to question order. Imagine that our example survey always posed the “bed or meal” question before the “healthy diet” questions. Regardless of how the respondent answers the first questions, she’s now in a state of mind that could influence her next response. (“Ooh, I love luxurious meals. I guess a healthy diet isn’t that important to me,” or “I need better sleep more than I need a rich entree. I guess I healthy diet is important to me.”) To counterbalance, we might alternate the order in which these questions appear. Still, priming may occur in both orderings.

So how do we know if order effects have influenced our results? (Perhaps the better question is: how do we determine the degree to which order effects have influenced our results?) First, it’s important to know which variant of the survey each respondent answered, where variant refers to a unique order of questions and response options. Our example survey comes in (or should come in) four variants:

  1. Rate the importance of diet, then choose between meal or bed
  2. Rate the importance of diet, then choose between bed or meal
  3. Choose meal or bed, then rate the importance of diet
  4. Choose bed or meal, then rate the importance of diet

All respondents, then, fall into exactly one of these four “variant cohorts.” Let’s assume further that these cohorts differ only in the survey variant they answered; that our experimenters randomly selected the respondents from the same target population, and administered variant 1 to respondent 1, variant 2 to respondent 2, and so on in a cycle.

If, when comparing these cohorts, we find their aggregate responses diverging significantly from one another, we should suspect that ordering effects have distorted our results. All things being equal, the greater the divergence, the more significant the impact of order effects. Our experimenters were careful in recruiting similar respondents, after all, so the profile of responses from any subset should more or less match the profile of responses from any other subset. If that’s not happening, something other than question content is at play.

Precisely quantifying the impact of order effects is the business of professional statisticians, a noble breed from which the present writer stands apart. But as data managers, we owe it to good science to understand the concepts at play and to stand vigilant against their influence. In the end, the truth may not be balanced. But our instruments for finding it should be.

Click the image below to experiment with a counterbalanced form

Page of web form showing a question and four possible responses

Spotlight on: combinatorics!

How many ways are there to order n distinct items? Let’s ask the Brady Bunch!

In the photo to above, Cindy stands at the top of the staircase. But it might just as well have been Greg, or Marcia, or even Alice. (She is practically family.) In fact, the director might have chosen any one of the 9 Bradys (or honorary Bradys) to take the top spot. So there are at least 9 ways to arrange this loveable clan. But once the top spot is claimed, we have 8 choices remaining for the next spot. Multiply 9 possibilities for the top spot by 8 possibilities for the second, and we discover that there are at least 72 ways to arrange this brood. But, much like reunion specials and spin-offs, the madness doesn’t end there. We now have to fill the third spot from the 7 remaining Bradys. Multiple the 72 combinations for spots 1 and 2 by the 7 possibilities for spot 3, and we’ve already hit 502 line-ups. Keep going, and you’ll discover that there are 362,880 ways to order one of America’s favorite families alongside one of America’s ugliest staircases.

Of course, you recognize the math here. It’s just 9 factorial. And while n-factorial grows pretty darn fast as n grows, these values pose little to no challenge for computing devices. OpenClinica happens to run on computing devices, so we have no problems with these values either. Combine that performance with our features for generating random numbers (or changing form attributes according to participant order or ID, or both), and you have all the tools you need to implement counterbalancing on any scale.

And that’s much more than a hunch.

Souvenirs from Baltimore (SCDM 2019)

Thank you to everyone who helped make SCDM 2019 another fantastic learning opportunity. We were delighted to catch up with old friends and make dozens of new ones. If you weren’t able to visit our booth, attend our product showcase, or catch our panel discussion on key performance indicators, don’t worry — we captured the insights for you. You can download articles, best practices, and more right from this page.

Register now for OC19: All Hands on Data

OC19 All Hands on Data

Register now!

 

This year, sail the seas of OC4 in Santander, Spain.

This year, it’s all about discovery and doing. We’ll spend our time together working directly in OC4: creating studies, building forms, and becoming familiar with the dozens of new features and enhancements that continue to make our current solution the solution data managers can rely on for performance, flexibility, and security.

Two days packed with 30- to 90-minute workshops on:

  • Multiple queries, multiple constraints, and item annotations
  • Hard edit checks
  • Moving from datamart to Insight
  • Insight for key performance indicators (KPIs)
  • The power of external lists
  • Collecting and safeguarding Protected Health Information (PHI)
  • OC4 APIs
  • Data imports
  • Single sign on
  • Conditional event scheduling
  • An early look at Form Designer
  • FAQ on OIDs
  • XPath functions every user should know
  • CDASH forms
  • Getting to SDTM

Want to take part in OC19 but can’t travel to Spain? Register and join us via webcast! (Super User Trainees must attend in person.)

All registrants will receive access to an OC4 sandbox study in advance of the conference.

Register now!

 

 

How’s your health? Introducing a mobile-friendly SF-12

We’ve blogged about ePRO form design and the power of real-time calculation previously. Today we invite you to experience both on one of the most thoroughly validated self-reported health instruments of the last 30 years: the SF-12.

Take it for a spin one your smartphone, tablet, or laptop. We’ve paginated this form to minimize the chance of missing any item and all but eliminate scrolling. Scoring algorithms built into the form deliver immediate results. Yet the simplicity and familiarity of the paper form remain.

Instruments like these will only grow in importance, as regulatory bodies and payers continue to call for more real-world evidence. These same stakeholders are also embracing digital: unlike paper, electronic forms capture the date and time of entry (helping to avert “parking lot syndrome“), and can even prompt a participant to revisit skipped items. The result is a dramatic increase in data quality and response rates, along with a concomitant reduction in delays and transcription costs.

Why wait for data, only to discover how compromised it is? Start building your smart, responsive ePRO forms now!

 

Complete this form on your smartphone! Just go to bit.ly/ocsf-12 on your device’s default browser.

It’s just a form. What’s to know?

If you’re new to clinical data management, that question is understandable. You’ve never had any trouble building surveys online, after all. You asked for numbers, and got numbers. Solicited preferences, got preferences. What difference should it make now that the data you need is medical?

Experienced clinical data managers know the answer all too well. Data that concerns the safety and efficacy of a treatment, or that’s meant to describe the course of a disease, is the informational equivalent of dynamite. Handled properly, it can open new avenues. Handled improperly, it can lead to disaster. In any case, how we collect this data is heavily regulated.

Don’t let your efforts to capture better data, faster, end in an explosion. We’ve produced The Ultimate eCRF Design Guide to help you build forms that will:

  • deliver the highest quality data
  • speed time to capture
  • enable the widest possible integration
  • facilitate robust and rapid analysis
  • make regulatory submissions smoother

There are tools for the newcomer and veteran within these pages, so register for free now, and be sure to subscribe to updates.