Exploring AI Usage in Clinical Research

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With AI on everyone’s minds these days, we wanted to explore AI usage in the clinical research field.  We found plenty to be excited about.  In part 1 of our 2 part exploration, we got AI to tell us a little bit about how it works in the real world.

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Industry News: New Study Shows DCT Methods Helped Lung Cancer Trial Enrollment as COVID Surged

Remote and flexible trial approaches have been a hallmark of clinical trials during the pandemic and are widely believed to have been the primary factor in keeping trials open and operating. There is evidence showing that such measures as telehealth visits, off-site diagnostic/monitoring procedures and remote consenting were at least partially responsible for the ability of lung cancer trials to weather the storm.

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The Trial Master File 10 Essentials for Success

A Trial Master File (TMF) is a collection of all essential trial documentation that enables effective monitoring, data integrity, and compliance throughout the lifecycle of a clinical trial. Learn about best practices and approaches for Trial Master File management.

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Clinical Trials Monthly Case Study Analysis: Cost Reductions / Hematology

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question; this time it’s a look at an orphan indication in HEMATOLOGY, and significant cost reductions for the sponsor:

We asked ourselves:

Scenario: A Phase IV study was required by the FDA as a condition of approval of an orphan drug. The sponsor was faced with monitoring, managing, and locking data for a 12-month study conducted at 100 sites.

Criterium offered an integrated technology-enhanced solution that allowed the sites to register ePRO Patient Diaries Input-Output Diagrampatients and allowed the patients to record their event data directly into our remote systems.

Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.

What If: If the client had used traditional methods, the cost would have soared for a product that has modest revenue and it would have taken much longer to provide the data to the FDA and the prescribing community.

Results: Criterium’s centralized real-time data accession utilizing Automated CRFs and Interactive Voice Response (IVR) medical history and patient diary application saved the client $1 million to $1.5 million in clinical monitoring and data management costs. In addition, the data were satisfactory for rapid submission to the FDA for conditional approval, were provided to the medical community to support the indication for which the drug was approved and numerous publications resulted from this fairly large body of data for this orphan indication.

Read more of our successful case studies

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Why Get Clinical Trial Data Feedback in Real-Time?

Real Time Data ManagementClinical trials data management is essential for medical and clinical researchers, doctors who assist with pharmaceutical drug development and C-suite decision makers in pharmaceutical drug development. The “3-C’s” of site management include connection, communication, and control.

The value of real-time clinical trial data feedback lies in enabling these medical professionals to attend to each of those “C” actions. The real-time connection and communication allows pharmaceutical professionals to review incoming trial data in real-time and control its dissemination and implementation in order to support making critical business decisions mid-stream in a project.


Importance of Real-Time Clinical Trial Data Feedback

As professionals working in the ever-changing world of medical research, we know that outdated information is ineffective for making important decisions that are vital to safe health practices. When medical professionals make decisions during prescription drug development, those decisions can affect people’s well-being and even their lives. This is why clinical trials data management must facilitate and implement real-time clinical trial data feedback, to provide the most current information and best practices within pharmaceutical drug development.

Implementing Electronic Data Capture (EDC) as a key strategy for clinical trials data management of real-time clinical trial data feedback assists pharmaceutical professionals in several essential areas:

  • Real-time immediate feedback: Allows for transfer of data in real-time; rapid resolution of discrepancies; reduction of time and costs; acceleration of query management; and verification and correction of inconsistencies in data in real-time.
  • Up-to-date accessibility of trial information and feedback: Allows for organization of global research data into a single database; provides up-to-date study statistics; enables less time to develop and produce essential statistical reports; and decreases risk of data blinding errors.
  • Safer, higher quality of data: Allows for encryption of data, which prevents any changes, deletions, or modifications; facilitates faster data cleaning processes; and automates editing and discrepancy checking.
  • Integrated safety data: Allows for crucial medical safety reviews regardless of data source’s originating country or time zone.
  • Adverse trends: Allows for tracking and reporting on adverse trends occurring with select pharmaceutical drugs.
  • Ongoing workflow: Allows for workflow to continue on an ongoing basis with real-time data, integrating and updating information as it is received.
  • Cost reduction: Allows more cost-effective means to share and store data, feedback, and other relevant clinical trials information; reduces the number of necessary field monitoring on-site visits; reduces clinical research costs; and reduces cost of introducing new drugs to the pharmaceutical market.

Consider ThisData Stream
Implementation of data standards for real-time information flow within clinical data management:

  • improves efficiency of trials and their relevant feedback;
  • allows for maximum usability of tools
  • enables combining data across clinical studies
  • facilitates collaboration across departments and organizations
  • promotes easier and more effective implementation of the three “C’s” of site management by connecting authorized parties to real-time clinical?trial data, communicating clinical trial data, and controlling the safety of clinical trial data and its related feedback.

EDC ButtonOverall, clinical trials data management of real-time clinical trial data feedback has proven to be the most positive and effective way to promote health and safety within the pharmaceutical development process.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Clinical Trials Monthly Case Study Analysis

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question this month it’s a look at SAFETY and ADVERSE EVENTS and the value of an electronic, real-time reporting system.

The Scenario: Criterium conducted a multi-center study across continents that required time-sensitive safety review but posed the challenge of a 7-hour time difference.

We asked ourselves:
What If: We could program our in-house EDC to provide real-time data in order to review safety information on an ongoing basis and make important study decisions; the absence of which would significantly impact safety and the overall project goals.

Criterium Patient Profile Reporting: The PatientProFileTM

  • In 2006, Criterium developed the PatientProFileTM reporting system to provide real-time information to our New York data center from our South African clinical operations office where enrollment was ongoing.
  • By integrating required safety data into a PatientProFileTM reporting system, we allowed for important medical safety review without having to take the significant 7-hour time difference into account and improved the Data Management process.
  • The PatientProFileTM reporting system connected two continents participating in a single clinical trial. As of 2013, the PatientProFileTM reporting system is used in all our clinical trials, USA-based and Global.

Patient Safety and Reporting

The PatientProFileTM reporting system produces individual reports for clinical trials, integrating data such as Demographic, Laboratory Results, Adverse and Serious Adverse Events into simple, real-time reports that can be reviewed as data is entered on an ongoing basis from any web-based computer.

The benefits of the PatientProFileTM reporting system are many and include, but are not limited to:
– Provision of data to Data Safety Monitoring Board(s)
– Review of data for interim analysis
– Provision of adverse event trending information
– Abstract/manuscript preparation
– Go/N-Go decisions

Our Result: The PatientProFileTM reporting system allowed the sponsor to make important safety decisions and necessary changes to the study design that provided scientifically valid data and protected the safety of all trial participants.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Q&A with Greg Bailey: IVR vs IWR ? Which is Best for YOUR Needs?

Greg Bailey Knows IVR IWR EDC ePRO Patient Diaries
Greg Bailey Knows IVR IWR EDC ePRO Patient Diaries

1.???????It?s like alphabet soup ? what do all the initials mean?

  • IVRS is Interactive Voice Response System ? this is what is usually referred to as voice menus (?Press 1 for this, Press 2 for that?), and we use those functions to allow patients to input detailed answers to trial-related survey questions.
  • IWRS is Interactive Web-based (or Web-board) Reporting System? this is the part of the system that the trial site and the sponsor use to see the results of patient input
  • ePRO ? Electronic Patient Reported Outcomes ? uses? IVR and IWR to capture and report all this trial data from patients
  • EDC is Electronic Data Capture, or another way to describe the IVR-IWR system as a whole

2.???????How do you implement IVR systems for a trial?

  • Criterium hosts our IVR applications in Boca Raton, Florida.? We contract with a toll free forwarding company to take international calls and forward them to the Florida Data Center.? This means we are able to provide a local number anywhere on the Globe that is then transferred to Florida. Once the application is moved into a production environment the focus of technical support is making sure the IVR will pick up when called.
  • The system manager in Florida utilizes automated monitoring software in conjunction with manual testing of the production applications.? Someone on the study team will be trained and involved throughout the development, testing and deployment process so they will have a good understanding of the application as a whole.? That will allow the project member to respond quickly to questions from the client.

3.???????Have IVRS systems replaced IWRS systems — or vice versa?

  • No, the IVRS and IWRS systems are built to complement each other.? Both systems access the same database so they are really just two portals into the same information.
  • IVRS is better suited for situations where there is limited internet access or the type of information being collected is minimal and concise, such as patient diaries, patient registration or randomization.
  • IWRS is better suited for reporting and entering textual information, such as comments, and where internet access is stable.
  • The IWRS can do anything the IVRS can do, while the IVRS is limited to what can be entered via telephone keypad entries.

4.???????Does Criterium have its own servers?

  • Yes, we have our own servers and all necessary equipment to handle large volumes of phone calls and web applications.? We have a strong investment in the infrastructure.? We have redundant internet and phone circuits as well as servers.? Our server room has backup power supply and is in a very secure location.

5.???????Which is most cost effective ? IVR or IWR?

  • That depends on the application.? Usually the IWRS is built first to allow administrative functions (site maintenance, login maintenance, reporting, and more) and then the IVR registration / randomization of subjects is added.? Since it is tailored to every specific trial?s requirements, it?s easier to say that it?s a real-time data advantage that you can?t afford NOT to have!

Read more about EDC from Greg Bailey:

hubbut_edc1

Got Questions? We have Answers! Contact us at?CriteriumBlog@criteriuminc.com