Around the World in Three Data Integrations

Big data has been a recurring topic in medical research news for years now. It’s a topic that deserves our attention. Big data’s potential to revolutionize fields like genomics and to advance precision medicine generally is stunning. Today, though, a lot of the press is speculation. Robustly effective designer drugs for cancer, based on the patient’s genetic markers, remain an ideal that is likely decades away.

But if we adopt a broader conception of big data–one that includes the massive infrastructure supporting social media, the Internet of Things, and (potentially) interoperable health record platforms–real world applications are not hard to find.

March 2015: Researchers at Stanford University recruit 11,000 subjects into a cardiovascular study in 24 hours using Apple’s open source ResearchKit app.

September 2015: “By outfitting trial participants with wearables, companies are beginning to amass precise information and gather round-the-clock data in hopes of streamlining trials and better understanding whether a drug is working… So far, there are at least 299 such clinical trials using wearables, according to the National Institutes of Health’s records.” – Bloomberg News

July 2016: The National Cancer Institute introduces OpenGeneMed, “a portable, flexible and customizable informatics hub for the coordination of next-generation sequencing studies in support of precision medicine trials.”


One facet of these examples stands out. For all their diversity, projects that rely on big data rely just as much on collaboration.
Moving from genomes to biomarkers to disease risk models and personalized treatment requires more than one big dataset: it requires the integration of data from multiple systems that are secure, geographically separated, and disparately schematized.

Ten years ago, the ability to handle this task might have been seen as a leading-edge, if not commonly leveraged, feature of clinical technology. Today, software that cannot facilitate integration is doomed to obsolescence.

eCitizen of the Data World

What does this requirement mean for EDC? Simply put, those of us building data capture solutions need to look far beyond the “coordinator keying in vitals” use case. (Our solution for that use case had better already be rapid, reliable and easier to execute than ever, considering the burdens placed on trial sites in 2017.) With “insight by integration” at the forefront of research strategies, we technologists had better think of our system as a world traveler: one familiar with the laws in multiple countries, authorized to enter and leave those countries, and fully knowledgeable of their languages and customs. In the world of data management, this means the ability to pass authentication to enter a source database, map the data to a target, and leave the source while maintaining data provenance.

As a long-standing promoter of open, standards-based interoperability, OpenClinica represents this “world traveler.” The native language of OpenClinica’s EDC is the Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM). This fact alone makes the OpenClinica data model an ideal cosmopolitan, instantly conversant with research peers around the globe. But holding fast to one standard is not sufficient. We need to be willing to learn new languages. By offering a well-documented web services API, OpenClinica makes it easy for its users to leverage RESTful web services, together with OAuth protocol version 2.0, to systematically:

  • extract data from almost any third-party source (e.g. labs and imaging centers),
  • associate each element of that data to the relevant Case Report Form (CRF) field.

APIs and authentication protocols offer the most direct route to turnkey integration. But it’s not enough to be powerful in the pursuit of data integration. A system has to be flexible, too, when tapping data sources that aren’t available to an API. For OpenClinica, this means providing a host of configurable tools to data managers and data entry personnel.

  • OpenClinica’s Jobs feature allows for custom imports from local files. A Job may be scheduled to run at any frequency, so that users responsible for data entry based on a regularly updated flat file (e.g. a CSV on their hard drive) may provide that data without keying in each element. A Job well-defined and set up just once improves accuracy and saves hours of research time.
  • An Import Data feature makes ad hoc batch uploads easy, as well. Users simply generate a XML file based on OpenClinica-supplied Object Identifiers (OIDs) to map data from the import file to the EDC.
  • OpenClinica supports a variety of Single Sign On (SSO) protocols, reducing repetitive authorization while maintaining security. OpenClinica is also an early and already experienced adopter of SMART on FHIR, a set of open specifications to integrate its core EDC with Electronic Medical Records (ER) and other health IT systems.

A Look at Our Passport

So far, I’ve outlined a set of capabilities required of any EDC in 2017, and claimed that OpenClinica meets them all. But where’s the evidence? In the second half of this post, I’m going put three of our partners in the spotlight. For each, OpenClinica was able to play a pivotal role in bringing together multiple data sources.

The Dutch Translational Research IT (TraIT) project, an initiative from the Center for Translational Molecular Medicine (CTMM),  “enables integration and querying of information across the four major domains of translational research: clinical, imaging, biobanking and experimental (any-omics).” While multiple systems power that integration, OpenClinica is the central hub. TraIT continues to host and support https://www.openclinica.nl, having joined together 10 trials on the platform in October of 2011. By March of 2015, adoption had grown to include 852 users at 157 sites conducting 136 studies, and by October of 2016, that usage had grown to more than 2,800 researchers and 250 research projects.

Among the selection criteria used to evaluate and ultimately select OpenClinica as a partner, TraIT specifically cited:

  • “links to other data storage and analysis tools within the TraIT platform, allowing researchers to integrate and analyse case report data, imaging data, experimental data and bio banking information,” and…
  • the “possibility to integrate with Trusted Third Party which handles proper (de-)identification of participant data within OpenClinica and other tools/services used in TraIT.”

It is worth noting that, in addition to an infrastructure that allows database integration, TraIT relies equally on OpenClinica’s open source model to build custom integrations. “The advantage of the Open Source model compared to a proprietary model, is that multiple independent contributors can review the source code, making enhancements which are then added to the version available to the entire OpenClinica community.”

Usage by the broader community helps ensure the innovation’s longevity and continued evolution. TraIT leverages these tools (such as the OC Data Importer) to help their sites import vast quantities of data in bulk fashion, eliminating transcription errors and delays.

The 100,000 Genomes Project, led and funded by Genomics England, is another example of a large-scale effort to combine clinical and genomic data. The 100,000 Genomes Project is sequencing 100,000 genomes in order to:

  • better diagnose rare disease,
  • understand its causes, and
  • set a direction for research on effective treatment

Whole genome sequencing (WGS) offers the best hope for determining which genetic mutations give rise to particular phenotypes, including disease states. WGS yields the syntactical equivalent of the three billion nucleotide base pairs that make up just one strand of one individual’s DNA, so a research program involving even one such sequencing has already entered the territory of “big data.” While highly specialized systems are responsible for sequencing itself, and yet others for the analysis of the output, an equally essential tool for this research is a system that can manage the clinical data and biospecimen tracking of subjects visiting one of several geographically dispersed clinical centers. Here, too, OpenClinica serves as the hub. Researchers at 13 NHS Genomic Medical Centers are using OpenClinica to register participants, capture clinical information, and ensure that blood samples stay matched with their de-identified contributors.

Project leaders have made public a 10-page guide to researchers on this process, one whose brevity and clarity speaks to how easy OpenClinica makes it. Due the dedication of the researchers, collaboration of participants and the fitness of the technology, the project is on track for completion in 2017.

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PECARN, the Pediatric Emergency Care Applied Research Network, is the first federally-funded pediatric emergency medicine research network in the United States. To date, PECARN has conducted 24 studies that have already changed how clinicians are preventing and managing acute illness and injury in children.

As part of their mission to advance clinical practice, PECARN has taken a lead role in the implementation and study of clinical decision support tools. For all the potential benefit offered by these tools, questions remain about their adoption and effectiveness. Do physicians and nurses generally follow evidence-based recommendations for treatment or diagnostic procedures? When they do, are outcomes improved?

To help answer these questions, PECARN study leaders conducted a nonrandomized trial with concurrent controls at thirteen emergency departments between November 2011 and June 2014. These thirteen departments were consolidated into ten research sites. At eight of these sites, clinicians creating an EHR record for any patient <18 years old with minor blunt head trauma were automatically presented with a custom template. This template solicited additional data about the injury before providing recommendations on CT use and risk estimates of clinically important traumatic brain injuries. (CT imaging of the brain is associated with a non-negligible risk of tumor formation in those who undergo the procedure, especially children. At the same time, early detection of ciTBI–i.e. injuries leading to death or requiring neurosurgery, intubation for more than 24 hours, or hospital admission for two or more nights–is critical for effective intervention. The recommendations provided by the EHR template were intended to limit CT use to those patients who met established predictive criteria for significant ciTBI risk.)

The clinicians work in their EHR, together with subsequent cranial imaging and TBI-related outcomes, all generated data that would require aggregation to determine (1) how frequently care providers heeded recommendations surrounding CT use, and (2) whether the predictive rules for ciTBI risk were valid. That aggregation fell to OpenClinica. By accepting reports generated by each site’s EHR to automatically create study subjects, and by integrating with the source of imaging data at each site, OpenClinica enabled a true e-source study that left clinical workflows unaffected. Not one of the 28,669 subjects created in the study database required manual data entry.

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Images courtesy of Jeff Yearley, BA, Manager of Clinical Data Management, Data Coordinating Center, University of Utah. Click here to download the slides containing the images above.

The moral? Big data isn’t just found: it’s made, through the coordinated efforts of both people and systems that travel light and fast. You’re contributing to big data during more and more of your waking hours these days. If you want to help shape it through technology, get ready to cooperate… and pack your digital bags.

OC Participate Delivers Better Data, Faster, Again

Some topics in clinical trials bear repeat attention. With patient-centricity claiming more and more of the spotlight in both research and care (rightfully so), we think patient-reported outcomes is one of them.

In our
last post, we described some of the most common obstacles to getting quality data from PRO measures. Patients, especially those are very sick, don’t want to hand-write dry medical diary entries. They don’t want to learn yet another electronic device, download and manage an app, or have to recall yet one more password. And who can blame them? Trial participants are the heroes of the research story, and when it comes to the collaborative process of data gathering, they deserve a hero’s welcome.

That’s why we developed OpenClinica Participate. We’re gratified by the success our clients have found leveraging this innovative ePRO solution, but we’re not surprised. When you prioritize a trial subject’s convenience and obsess over making things simple, you simply get better results. Here’s another example. Let’s call it:

Out with the old, in with the new

OpenClinica teamed with Danish CRO, Signifikans, to implement OpenClinica Participate for a leading Denmark-based bioscience technology company developing an innovative treatment to alleviate colorectal disorders, a common side effect of numerous medicines affecting millions of people at any time. The study’s objective was to investigate exercise induced intestinal permeability, immune markers, and bowel habits in 18-40 year old healthy volunteers. Participants were given two strains of bifidobacterium, an anaerobic bacteria that resides in the intestinal tract. The study involved 48 participants throughout Sweden, and each patient was required to provide 65 daily diaries in addition to 5 in-person visits over the course of the study.

The Old Way

In a similar prior study, the sponsor collected paper diaries from 700 participants. Each participant provided their (hopefully) completed and accurate paper diary to their site coordinator during the in-person study visits. The site coordinators then delivered the completed paper diaries to a data coordinating center. Coordinating center staff then scanned the diaries into a document management system and an overseas data entry vendor used a double data entry workflow to populate a database. Completed diaries were scanned and uploaded in batches for data entry. Phew!

On average, four months elapsed between the point of data capture and the first day of availability of that data to the sponsor. Monitoring participant compliance was also a challenge in this study, as it was
impossible to discern when each patient actually completed their daily diary. The expenditures associated with this process for data entry tallied over $213 per patient diary, or $4.97 per diary page.

Overall, this process was cumbersome, expensive, and logistically complex. The sponsor was planning a similar new study, and this time around was determined to find a way to

  • get faster access to the study data,
  • improve data reliability, and
  • reduce costs

The New Way

The sponsor enlisted local specialty CRO, Signifikans, to help it identify and implement a better approach. Signifikans recognized that with OpenClinica Participate, the sponsor could have immediate access to patient data, and that this data would automatically sit right alongside data captured from other sources during the study. No EDC integration was necessary.

Signifikans also took the lead on configuring the study in OpenClinica. (Our “make it simple” credo guides how we design tools for data managers, as well. That’s why we have invested so much in our forms engine, a topic for another post.) While building the study, Signifikans was able to easily demo prototypes to the sponsor along the way, iterating rapidly through edits and changes. Data capture forms were developed in the Swedish language, and the study was configured to send email reminders to patients to help ensure diaries were completed on time. The reminders contained a secure, uniquely-identified link the participant could click to go right to their diary, eliminating the need for participants to remember usernames and passwords.

Results

As soon as the study went live, the sponsor was able to monitor precisely when data were captured something that was not possible with the old paper-based method. They observed, for example, that all five participants enrolled in the study’s first week each completed their diary card daily, per the protocol. The sponsor’s confidence in patient compliance and data quality surged; so much so, that they implemented an increase in the amount of data being collected this way. Scaling that quickly would have been impossible with paper diaries and slow transcription processes.

“Participate was very low friction: set-up was quick and efficient, and patients really seemed to embrace the technology.”

– Andreas Habicht, CEO, Signifikans Aps

The OpenClinica solution delivered a unified study database out-of-the-box, with patient-reported data sitting alongside clinician-reported data and accessible via the same interface. Having everything in one audit log made it easy to follow the patient’s trajectory through the study. Signifikans was able to use the same tools to configure and manage both ePRO and non-ePRO aspects of the study, resulting in a faster time-to-launch, and facilitating mid-study changes.

In addition to enhanced data quality and faster access to data, the cost of data capture per diary with OpenClinica Participate resulted in cost savings of over 80%.


Comparison: Paper vs. Participate
(click to enlarge)

Keep an eye out for more ePRO success stories on this blog. Our next post will delve into a different topic, but, as with this one, you can be sure it will feature better results through a better eClinical experience.

An ePRO Case Study

What does the term “source” bring to mind for you? Paper files? A clinic’s EMR? Fair enough. Those are the typical formats of source data in clinical trials. But when you think about it, those records are a few removes from the true source: the patient.

Granted, most trials depend on a host of instruments and analyzers. No patient can self-report their own hemoglobin levels. But there are measures, such as quality of life, whose source really is the patient’s own experience. And for an industry whose raison d’être is enhancing (and sometimes saving) lives, we have a hard time obtaining those measures.

That’s not to say that patient-reported outcomes are a rarity in clinical trials. In fact they’re common. But so are obstacles to collecting them. Even today, with several ePRO solutions on offer, too many trials rely on patients to complete paper diaries. But paper records are prone loss or damage. Also, it’s virtually impossible to tell whether a patient made daily diary entries as instructed, or retrospectively wrote responses just prior to a study visit, raising data quality concerns. (Here’s a great analysis of “parking lot syndrome”.)

“Mochaccino with a side of ePRO” has to become the new normal for trials

ePRO is a big improvement on paper, but it doesn’t integrate seamlessly into a patient’s day to day life. Nearly all trials today using an electronic system for PROs provision dedicated devices to patients for this purpose. Patients need to be trained on how to use this device, recall that training at the relevant time, and make a habit of keeping the device on their person to stay current with reporting tasks. These systems also require patients to remember passwords and other access credentials. A step as apparently simple as downloading an app can be fraught with challenges: the patient must remember their app store login, locate the download area, have sufficient memory on their phone to house and run the app, ensure the app installs successfully, and ensure it remains installed, running, and updated.

All of the above examples are potential points of failure that can compromise the quality of real world data and increase trial costs. These myriad tasks and responsibilities unrelated to the data itself can place a significant burden on a volunteer patient, particularly one who is very sick.

OpenClinica Participate eliminates potential points of failure by:

  • providing an system that can be used on the patient’s own device(s),
  • eliminating the need to patient’s to remember login credentials, and
  • removing the complexities associated with apps.

This helps place the patient at the center of the research. And perhaps best of  all, OpenClinica Participate places the patient reported data into the master EDC database in real-time with zero additional effort.

The advantages of this approach aren’t just theoretical. OpenClinica and its partners have realized their benefits in more than 20 studies since the launch of OpenClinica Participate about a year and a half ago. In this post and future ones in this series, I’d like to share some short and informal case studies. I call this one:

On time, nearly every time

In a phase II study assessing the prophylaxis of a nasal powder in subjects challenged with rhinoviruses, subjects were asked to self-report symptoms at 27 time points over 12 days. On 7 of the days, self-reports were to be submitted in the morning, in the afternoon and at night. To help drive compliance with this rigorous self-reporting schedule, trial managers needed to engage their subjects and ensure their convenience. To do so, they tapped the ability of OpenClinica Participate to present clear, attractive eCRFs to patients right on their own mobile device or laptop. Data managers established rules that fixed the date of all future study events based on the date of enrollment. OpenClinica Participate automatically sent text messages and emails to each subject hours prior to a scheduled event, directing them to the relevant data capture form regardless of which of their devices they happened to be accessing at the time. (This is a best practice, with hours spent online per day continuing to grow around the world. And while a crowded “app” field may fragment populations – a Snapchat user is not necessarily an Instagram user – an email client and SMS messaging feature can almost always be found, and found running, on any web-enabled mobile device.)

In this case, success would mean the vast majority of study subjects not only entering their data, but doing so in real-time; that is, once in the morning, once in the afternoon, and once in the evening on each of those 7 critical days. And that’s just what happened.

Of the 115 subjects who completed at least one of the 27 ePRO forms, even just a basic intake form, 89 (77%) completed all of the 21 forms required in the morning, afternoon and evening of seven consecutive days, when timely reporting was most critical.

Of the 1,892 “3x daily” forms completed, the vast majority were completed in “real-time”:

Forms CompletedWithin 4 Hours
(of 6am, noon and 5pm
respectively)
% Within 4 Hours
Morning63059995.08%
Afternoon63161296.99%
Evening63160495.72%

“Bring your own device” may not be the final frontier in ensuring patient convenience. Passive monitoring by nearly invisible devices is already a reality. But the principle will never change: let technology do the work, so people can live their lives.

 

My Resolution for 2017

The traditional month for making resolutions is over, but since the first day of the year, I’ve been hard at work on mine. I shared it with my team members early in January, and now I want to make it public.

My resolution for 2017 is to make life easier.

Not necessarily for me–though I’d take it–but for clients and collaborators of OpenClinica. The pace of clinical research will only accelerate, so eclinical software (and its users) will need to keep up or get left behind. While we can always make improvements in processing power and data storage, the big gains will come from empowering our users to do more in less time and to rapidly make smart decisions. In the world of electronic data capture, that means giving data managers powerful tools to get studies started, to seamlessly integrate randomization, EDC, and ePRO, and to gain insight into their queried and missing forms.

As a team, we’ve adopted “making the complex easy” as our theme for 2017. As you’ll see in the posts below, we’re poised to do just that. We have new clients that will challenge us to break new ground. We have new team members bringing that rare combination of domain expertise and raw passion. And we have a growing appreciation of the role ePRO will play in identifying therapies that aren’t only efficacious, but effective. So if my life doesn’t get any easier this year, it’s still bound to be exciting.

Our newest clients represent the future of research and care

New client relationships are exciting in any business. But they don’t get much more gratifying than the ones we’ve been fortunate to make. Looking back over the last six months of new client relationships, I’ve been struck with the emergence of some inspiring trends. A focus on personalized medicine. The willingness to take on looming problems in population health. The application of advanced computing and “big data” to challenges old and new. It’s been a potent reminder of the impact that our work here at OpenClinica makes possible.

Here is just a sample of the new partners that are energizing us:

The biotechnologists at miR Diagnostics specialize in the development of prognostic testing in cancer treatment. Their mission is to provide people diagnosed with cancer a deeper understanding their disease, and to help them make the safest, most informed treatment decisions possible. Using state of the art research, miR Diagnostics has developed cutting-edge, prognostic cancer testing systems that provide insight into tumor progression previously impossible to ascertain.

With Tools4Patient, too, medicine is personal. Tools4Patient develops companion diagnostics which contribute to the design of new treatment paradigms to improve outcomes and enhance quality of life for patients. Their first commercialized tool, Placebell, increases the sensitivity and power of clinical research results through improved Individual Placebo Response characterization.

From microbial pathogenesis to gene therapy, The Research Institute at Nationwide Children’s is claiming new frontiers on behalf of children from around the world. Add to that incredible mission a suite of stunning computational resources, and we knew we needed to work together.

Mercy Research, a centralized, multi-faceted research group within the Mercy health system, conducts more than 700 clinical studies at any given time. They’ve developed more than 40 innovating products and are now building one of the foremost teams for healthcare analytics. Suffice it to say, we’re proud to play our role in this enormous enterprise.

Malaria is responsible for more childhood mortality than any other single infectious agent. At Sanaria, through collaborations with renowned institutions like University of Tübingen, Germany, research is taking on a big aim: eradication through vaccination.  

Biolux Research develops technologies that enhance clinical outcomes and dramatically reduce treatment timelines in dentistry, implantology and orthodontics in a safe, effective and non-invasive approach. Learn how they’ve already succeeded with OrthoPulse®.

Again, these are only examples. In the space of a blog post, I can’t do justice to these missions, those of the new clients I didn’t mention, and the many we’ve been helping to advance for years. But I will be reporting our progress in making all these ventures like these as successful as they can be.

 

New eCRFs (Colleague Revelation Forms)

OpenClinica has welcomed several new team members over the last few months. We’ve collected some eCRFs (Collegue Revelation Forms) to introduce them!

Name: Paul Bowen
Title: Product Owner
Responsibility: I bridge the gap between our stakeholders and our engineering team to ensure that we build the features into OpenClinica that are needed most.
Background: Prior to joining OpenClinica, I spent ten years at Quintiles/Outcome Sciences developing an EDC platform for late phase studies. I also spent one year at Clinical Ink working on a patient engagement app.
What I love about research: I like being a part of something that is making people’s lives better in a significant way.
What I love about technology: Technology provides us with many new options to improve the way we do research. Working to figure out the best solutions is a fun part of this job.
What I love outside of work: When the weather is nice, my girlfriend and I like taking long walks with our dog. When it’s not as nice, we like watching sci-fi TV and movies.


Name:
 Bryan Farrow
Title: eClinical Catalyst
Responsibility: I’m the link between the data management community and OpenClinica. It’s my job to distribute news about our products and services to data managers who’ve been looking for solutions to industry-wide problems like integration and ease of use. Just as importantly, I bring unmet challenges back to our incredible team of developers and customer success professionals so that we can find a solution.
Background: Prior to joining OpenClinica, I spent five years at DrugDev, learning how just how much technology can affect the duration, cost and experience of running a trial. Prior to that, I was responsible for physician and patient communications at Boston Children’s Hospital.
What I love about research: The journey and the destination. Asking questions, devising ways to get an answer, and analyzing evidence are thrilling. With clinical research, we get to do all that with the aim of improving lives.
What I love about technology: For me, technology comes down to problem-solving. If you’re curious and persistent, you can always find a better way. And it’s so gratifying when you do.
What I love outside of work: My family above all. I love being a father to my two kids and a partner to my incredible wife. But when I need some “me time”, I usually reach for a book or journal dealing with philosophy. That was my major in college, and I’m still enamored with the power of logic and the gravity of big ethical and political questions.

Name: Brittany Stark
Title: Project Manager
Responsibility: I direct client projects involving the implementation of clinical trials using OpenClinica software. I oversee the planning, build, testing, and delivery of client projects on time, within scope and budget.
Background: Prior to joining OpenClinica, I spent 4 years in the Cancer Clinical Trials Office at Beth Israel Deaconess Medical Center, working with phase 0-IV clinical trials in oncology. During this time, I gained experience as a Clinical Research Coordinator, Regulatory Affairs Specialist and later Clinical Trials Staff Educator. Prior to this, I spent over 4 years working in academia at the University of Kentucky (in a Human Behavioral Pharmacology and Clinical Psychology Lab) and later at the University of Maine (teaching SPSS as part of a Research Methods and Designs Course Lab).
What I love about research: The potential to advance our understanding of the world we live in and change lives for the better.

Name: Chris White
Title: Customer Success Team Lead
Responsibility: I direct client projects involving the implementation of clinical trials using OpenClinica software. I oversee the planning, build, testing, and delivery of client projects on time, within scope and budget.
Background: Prior to joining OpenClinica, I spent two years in the consulting industry working with many different types of software. Prior to that, I spent 14 years creating positive customer experiences with two successful start-ups, helping to build their client focused operations.
What I love about research: There is still part of me that is the seven-year-old Calvin (from Calvin and Hobbes), always asking questions, wanting to know and understand the wide world around me.

 

 

What prevents you from doing (more) ePRO?

Patient-reported outcomes give us insights that no clinical assessment, imaging study and lab report can. For subjective measures, such as mood or energy level, there’s often no other source. But common methods of collecting PRO, from paper diaries to provisioned devices, pose real barriers. We want to know which ones you’ve faced. Tell us by completing the form below. We have more to say on the topic, but we want to start with your experiences!

Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 2 of 2)

When it comes to your assessing your trial technology, your data managers, study coordinators, Investigators and senior leaders are all study subjects.

In the previous post, I described the difference between efficacy and effectiveness, an increasingly important concept in clinical research and healthcare. After stressing the importance of effectiveness research to health policy planning and patient decision-making, I summarized seven criteria for identifying effectiveness studies. Finally, I asked whether these criteria could be re-purposed beyond a medical intervention to inform how we measure the effectiveness of software systems used to conduct clinical trials.

Is it possible to assess clinical trial software through the lens of effectiveness, as opposed to just efficacy?

I believe that it’s not only possible, but crucial. Why? We all want to reduce the time and cost it takes to deliver safe, effective drugs to those that need them. But if we don’t scrutinize our tools for doing so, we risk letting the status quo impede our progress. When lives are on the line, we can’t afford to let any inefficiency stand.

In this post, I adapt the criteria for effectiveness studies in clinical research into a methodology for evaluating the effectiveness of clinical research software. I limit the scope of adaptation to electronic data capture (EDC) systems, but I suspect that a similar methodology could be developed for CTMS, IVR, eTMF and other complementary technologies. If I open a field of inquiry, or even just broaden one that exists, I’ll consider it time well spent.

Continue reading Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 2 of 2)

Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 1 of 2)

Are you measuring all the relevant outcomes of your clinical trial technology?

For pure pathogen-killing power, it’s hard to beat a surgeon’s hand scrub. Ask any clinician, and she’ll tell you how thoroughly chlorhexidine disinfects skin. If she’s a microbiologist, she’ll even explain to you the biocide’s mechanism of action–provided you’re still listening. But how would the practice fare, say, as a method of cold and flu prevention on a college campus? Your skepticism here would seem justified. After all, it’s hard to sterilize a cough in the dining hall.

Efficacy and effectiveness. It’s unfortunate their phonetics are so close, because while the terms do refer to relative locations along a continuum, they’re the furthest thing from synonyms, as the ever accumulating literature on the topic will attest.

In this post and the one that follows, I’d like to offer some clarity on efficacy vs. effectiveness and illustrate the value that each type of analysis offers. If nothing else, what emerges should provide an introduction to the concepts for those new to clinical research. But I have a more speculative aim, too. I’d like propose standards for assessing trial technology through each of these lenses. Why? Because while we’ve been asking whether a particular technology does what it’s explicitly designed to do, as we should and must, we may have forgotten to ask a critical follow-up question: Does it improve the pace and reliability of our research?

Continue reading Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 1 of 2)