This community space is meant to be the hub for JMP Clinical. This information is for internal use only and should not be copied out into separate documents - this page is a work in progress and will be updated when we have new information to share.
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JMP Clinical Training
JMP Clinical Resources
What's New in JMP Clinical 8
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What are the key benefits of JMP Clinical?
- Significantly faster evaluation of clinical trials
- Improve understanding of the safety & efficacy of drugs
- Validated reporting for safety and efficacy
- Enables startups to behave like big pharma with out of the box visualization and analysis of clinical trials data
- Speed up the generation of the clinical study report (CSR)
- Improve accuracy of adverse event narrative section of the Clinical Study Report (CSR)
- Out of the box reporting for cancer trials following FDA Oncology Efficacy Guidance
- An understanding of how FDA will review final submission package
- Evaluating Phase I through Phase 4 clinical trials data
- Create Periodic Safety Update Reports (DSUR and PSUR)
- Automate loading studies, running analyses and sharing reports with clinicians
What does a clinical trial look like - what are the phases?
JMP Live Offerings.PNG
- Phase 2 and Phase 3 are where JMP Clinical is used.
- Typically, organizations do not make software decisions prior to phase 2 or 3 unless they have a coach who has prior familiarity with JMP C, also has budget and wants to establish a standardized approach early on.
What are the key features of JMP Clinical?
- Adverse Event Distributions
- Hy's Law
- Laboratory Time Trends
- Swimmer plots
- Tumor Response
- Progression Free Survival reports
- Patient Narratives and Patient Profiles
- Multivariate Inliers and Outliers
- Duplicate Records
- Correlation Patterns
What types of organizations or companies use JMP Clinical?
- Primarily small and medium sized Pharma
- Pharma and Biotech submitting clinical trials to regulatory agencies (search company here)
- Regulatory agencies evaluating clinical trials for approval (US FDA >400, PMDA =201, NMPA =20)
- Medical schools conducting clinical trials
What types of roles/titles/personas are the target audience for JMP Clinical?
Medical Writers: Producing adverse event narratives for clinical study reports (CSRs) can be a painstaking, time-consuming process with significant consequences for inaccuracies or delays. With JMP Clinical, medical writers can automate patient profiles and patient narratives and reduce the time and complexity of creating output for review and submission to regulatory agencies.
Pains:
- outsource to CRO's, Medical Writing services companies
- price per study population
- time consuming to QC
Benefits of JMP Clinical:
- Generate 100s of narratives in seconds
- Modify text for medical writers needs
- Keep templates for therapeutic areas
- Majority of data from a single source (same as medical reviewers)
- Deploy narratives with interactive patient profiles to writers
- Provide access to more safety and efficacy reports to explore more of the narrative
- Inexpensive: not per study but access to software on an annual basis
Medical Monitors/Data Monitors/Clinical Data Scientists: These roles typically either report to medical doctors or are a medical doctor. Summary dashboards in JMP Clinical enable medical reviewers to evaluate safety and efficacy issues with the click of a button. Create interactive reports of adverse events, concomitant medications, labs and vital signs, and drill down to customized patient profiles and patient narratives. They use JMPC to review the data in an ongoing trial.
Pains:
- Static/non-interactive tables, figures and listings are the standard
- Slow interaction between medical staff, scientists and biometrics/biostatistics
- Disconnection between tables and patient profiles
- Outsource pricing to be on a per study basis. Multiple studies could be occurring at the same time.
Benefits of JMP Clinical:
- Speed up communication between staff
- Specialized visualizations for safety and efficacy
- Ease of use with built-in reusable and editable workflows/templates
- Immediate access to patient profiles and patient narratives from any visualization or table
- Oncology specific views
- Perform in-house and have on-demand control of what reports need to be run and how often
- Feedback from regulatory agencies
- Summary dashboards allow them to evaluate safety and efficacy issues with the click of a button
- Create interactive reports of adverse event narratives, concomitant medications, labs and vital signs
- Easily drill down to customized patient profiles and patient narratives.
Clinical Operations: The goal of clinical operations is to mitigate data quality risks that could hinder a regulatory submission or drug approval. Risk-based monitoring tools in JMP Clinical help you identify data anomalies at the vendor, monitor, site and country level, and determine the factors responsible for lapses in safety or data quality.Operations are the “project managers” of the clinical trial. They care about: Do they have consent forms, do they have enough supplies, do they have the data they need? Operations will often be supported by biostatisticians to provide and interpret the more complex visualizations.
Pains for Risk-Based Monitoring (RBM) and Central Statistical Monitoring (CSM):
- Monitoring visit set on predetermined schedule
- All studies and sites treated equally
- Lower site monitor productivity
- Up to 1/3 (some say ½) of trial costs
- Human review is only 85% accurate
- 95% of data findings were or could have been identified from database
Benefits for RBM:
- Visits driven by workload, quality, safety signals
- Site monitor productivity focus is subject safety, data integrity and regulatory compliance
- Provides insight for trends across time, patients, monitors, investigators and clinical sites
Benefits for CSM:
- Patient/site performance using statically methods on on-going clinical trial data
- Site to site comparisons
- Looking for data anomalies with the database
- Interactive reports for drill down to details
- Uses same data used for medical reviews
Data Managers: Scrupulously maintaining the validity of all data throughout the trial process is crucial. JMP Clinical helps data managers visually monitor the status of all data and quickly identify new, modified, deleted or duplicate data. This lets you expedite database locking and ensures that downstream analysis will always be based on valid data. JMP Clinical helps data managers visualize the changes in the snapshots of the data. This allows them to monitor the status of all domains and quickly identify new, modified, deleted or duplicate data. This expedites database lock and ensures that downstream analysis will always be based on valid data. They don’t necessarily use JMP Clinical, but would use the data from it. They can easily determine if the data loads into JMP Clinical and is ready for interim visualization and analysis.
Pains:
- Being asked for a new slice of data frequently
- Lack of consistency, using different CRO’s
- High price of manual cleaning
- High price of expensive EDC addons to clean and visualize data.
- Disconnect from the visualization and analysis of the data.
Benefits of JMP Clinical:
- Enables automatically loading data for visualization and analysis by clinical teams using the JMP Clinical’s Application Programmers Interface (API).
- Use JMP Clinical to evaluate readiness of study data for visualization and analysis
- Easily visualize what changed in the data between to snapshots of the study data
- Use JMP Clinical patient profiles to determine if there is missing or conflicting patient data
IT: When considering JMP Clinical for an organization, IT is commonly involved and are important to the sales cycle. Often IT can be a gatekeeper. Installation, configuration and control of user access are their main concerns. Some suggestions:
- JMP Clinical, as with all products, can be installed on centralized hardware such as Citrix, Amazon or Azure with a Virtual Presentation Server license. Many of our larger customers use this license to simplify installation, configuration and sharing of study data.
- If they ask, you can share this JMP Clinical System Requirements document.
- Study data can be automatically loaded into the system as well as running templates using JMP Clinical’s API.
Medical Doctors: Ideal to get an MD in your meeting as they will see the value immediately, they have the money and they have the final say.
- They understand the clinical data better.
- They want earlier access to the data.
- They like to publish in medical journals with graphs and tables we generate.
- They prefer a tool that saves them time and does a lot of the data loading work for them.
What does the workflow look like in relation to user roles and trial phases?
JMP Live Offerings.PNG
What are the primary use cases for JMP Clinical?
- Automatically compose a configurable patient narrative for each subject who experienced an adverse event (AE), including reporting for deaths, serious AEs, AEs resulting in study discontinuation and AEs of special interest.
- Quickly identify efficacy signals in solid tumor clinical trials using visualizations tailored to RECIST criteria, including survival plots, swimmer plots, waterfall plots and spider plots.
- Assess trial data for safety issues with the click of a button and create interactive reports of adverse events
- Instantly generate customizable patient profiles and easily communicate findings among review groups.
- Discover data anomalies at the site and patient level, whether due to fraud, data quality or protocol errors.
- Visually identify modifications to data and isolate data entry and EDC errors for downstream users of the data.
- Reduce costly on-site source data verification while preserving data integrity and the safety of study participants.
- Reveal trends and outliers and accelerate discovery via interactive visualization and sophisticated pattern detection.
How do we know if a prospect is a good fit for JMP Clinical - what are some of the qualifying questions?
- Would you like to automate the generation of your CSR?
- Do your doctors and clinicians have to wait too long to get reports back from teams generating them?
- Would you like to have more oversight of your CROs?
- Do you have ongoing clinical and nonclinical studies?
- Do you have too many issues when submitting studies to the FDA or other regulatory agencies?
- How do you collaborate with other groups?
- How important is it to have interactivity in your reports?
- How do you share information today?
How much is JMP Clinical?
JMP Clinical is $14,900 for FYF (same as JMP Pro). There are volume discounts available. For more information, please refer to the JMP Clinical pricing page.
There are a lot of acronyms and terms for Clinical such as NDA, CRF and DILI. What do they all mean?
- IND: Investigational New Drug [Application]: Application to investigate a new small molecule therapy/drug in non-human trials to a regulatory agency
- NDA: New Drug Application: Application for approval of a new drug (small molecule) to a regulatory agency post Phase 3 clinical trial
- BLA (Biologics License Application) is what it is called for biologics
- CRF: Case Report Form (electronic version is called eCRF): Form used to collect information about patient who is going to be enrolled in the study.
- EDC: Electronic Data Capture: The database(s) where patent level information is electronically entered/collected and stored. Comes from CRF and other tests. eCRFs can be connected to EDC so information is directly entered into database.
- CTMS: Clinical Trial Management System: Software system to manage clinical trials (planning, tracking and basic reporting functions) https://en.wikipedia.org/wiki/Clinical_trial_management_system
- Database Lock: All data has been collected, quality check and modifications/corrections made. Ready for submission. No changes to the data can be made (its locked).
- ICH - International Council for Harmonisation (https://ich.org
Organization of industry and regulatory agencies to help harmonize the drug development process around the world.
- TLFs -Tables, Listings and Figures: Literally summarized subject count based tables, tables of subject level details, and graphs of desired content.
- DSUR: Drug Safety Update Report
- PSUR: Periodic Safety Update Reports
- CSR: Clinical Study Report - Used for submission to a regulatory agency for approval of a drug at the end of Phase 3
- PV: Pharmacovigilance (https://en.wikipedia.org/wiki/Pharmacovigilance)
- CRA: Clinical Research Associate
- PI: Principal Investigator
- DM: Data Manager
- AE: Adverse Event (i.e. Side Effect)
- SAE: Serious Adverse Event (i.e. a Serious Side Effect)
- AESI: Adverse Event of Special Interest: Some studies have specific AEs that they are monitoring or are known to occur
- ConMeds: Concomitant Medications: Medications that are not the primary study drug(s) that a patient might be taking for some other purpose or symptom. May confound a result or adverse event
- DILI: Drug-Induced Liver Injury (e.g. drinking too much alcohol)
What is a CRO and could they use JMP Clinical?
A CRO is a Contract Research Organization. They help drug and medical device companies conduct the clinical trials. The decision to change or compliment the CRO services comes when trials scale up (Phase 2-3). Many companies do not move away from the CRO model completely. Having JMP Clinical helps them manage the CRO more effectively and allows them to generate their own Narratives when deadlines are tight.
Where is JMP Clinical installed?
Must be installed on a local PC (Windows) to virtualized environment (similar to JMP and JMP Pro).
Can JMP Clinical be used for data that is not Clinical Trial data?
No, the data needed is specific to Clinical Trials and a bulk of the functionality is limited to the specific data structure. Additionally, the license agreement states that JMP Clinical must be use for Clinical data analysis purposes.
What if I have a strong candidate for JMP Clinical - what should I do?
- Find out if they have budget. Remember, MDs control the budget. Try to get them in the demo.
- Find out if they have right kind of data. Right data is "CDISC like".
- Schedule the demo.
Who presents the JMP Clinical Demo?
Some SE's are able to do their own JMP Clinical demos at an introductory level. If needed, your SE will work with Chris Kirchberg, Don McCormack or Valerie Nedbal to prepare for the demo. If they still need more support, Don, Chris, Valerie will help with the demo. If they are not available Geoff or Kelci will be able to help.
Are there any resources available where I can learn about some of JMP Clinical sales wins?
What are some JMP Clinical resources that I can offer a prospect or customer?
How significant is the learning curve for a client that isn't' familiar with JMP Clinical?
There is much variability here based on functionality usage, user role and desire.
- JMP Clinical has the ability to segregate report and review usage into Creator and Consumer, where the Creator determines the appropriate settings (which drop down menu options) and saves them as their own company or department specific templates.
- The Consumer is then fed the finished template, doesn’t have access to any of the settings and simply runs the reports against the new data. From here its point click and explore, just like JMP.
- We have default templates that contain the most commonly used reports and settings. The JMP Clinical User Guide is extremely comprehensive. It is not uncommon for us to have an initial session after the sale to build a template of initial reports, where the customer identifies the six or so reports they want to use, and we go through each of the settings articulating what they mean. Customer tells us which settings they would most commonly use. At the end of the session we have a customer specific template that we send them to get started.
- We also have formal classroom training via SAS Education, with course booklets with detailed descriptions including screen shots and exercises.
What has been the customer experience using JMP Clinical in a server environment?
There are few large pharma customers, with international users having a very positive experience. Mainly because extensive testing was completed during a Proof of Concept (paid trial) before final purchase and moving to a Production environment.
How much time do customers spend manually compiling patient narratives?
The narrative writing stages are:
- Initial Draft – The initial draft of the narrative that includes a thorough discussion of adverse events, blood tests, physical exam findings, and other serious or fatal safety-related events.
- Peer Review – The editorial review of the narrative for clear writing and to ensure that all narratives for the given study use a consistent data presentation and format as governed by applicable guidelines and quality standards.
- Clinical Review – The review of the draft narrative after the peer review to ensure clinically accurate data and a clear description of the findings being reported.
- Second Draft – The resulting draft after the medical writer addresses all feedback from the prior clinical review.
- Quality Control – The review of the narrative to ensure quality, align to the project requirements, and comply with the ICH E3 guidelines. This includes full data verification and checks for clear and consistent language, formatting, and typographical/technical checks.
- Final Version – The completed narrative that has all quality control process findings addressed. At this stage the medical writer ensures that the document is ready to be included with the complete set of narratives to be placed in the appendix section of the Clinical Study Report.
- You can review this paper from the 2020 SAS Forum for more info.
