Wakefield – Commitment to Change Statements Can Predict Actual Change in Practice
Commitment to change is one part of a complex process of change, recent progress has established a solid theoretical and research base to support this approach.
ArcheMedX To Present New Findings & Clinical Trial Innovations At The CNS Summit
Analyses of 42,656 clinician learners across 69 CNS-related educational activities reveals clinicians may be unprepared to effectively conduct clinical trials
Charlottesville, VA (PRWeb) November 16, 2022
ArcheMedX, the leading provider of clinician readiness solutions for the life sciences and healthcare industries, today announced the Company’s expanded participation at the CNS Summit taking place November 17th-20th in Boca Raton, Florida.
The Company will present highly anticipated new findings on “The State of CNS Clinician Readiness” at this year’s CNS Summit revealing the educational needs of clinicians treating patients and conducting clinical research across CNS-related conditions. ArcheMedX will also showcase how trial sponsors and CROs are deploying Ready, the Company’s innovative learning and predictive analytics platform to streamline study startup and optimize clinical trial delivery.
The 2022 edition of “The State of CNS Clinician Readiness” findings examine how many of the challenges in conducting more complex CNS-related studies are rooted in underlying process inefficiencies, performance challenges, and training gaps. The report reveals critical insights from analyses of learner data generated by 42,626 clinicians researching and treating neurological disorders such as Alzheimer’s, Migraine, MDD, MS, and Bipolar/Schizophrenia.
The data, analyzed across professions and clinical areas, demonstrate that more than 80% of clinicians are not adequately prepared to formulate a differential diagnosis, develop individualized treatment plans, or navigate the complexity of CNS care teams to provide appropriate treatment.
These variations in clinician mastery and deficiencies in readiness may delay patient enrollment, increase clinical trial costs, and worsen healthcare outcomes in clinical trials conducted across neurological disorders. Trial risks such as these can be reduced by delivering more tailored and effective study training that improves readiness across key research and treatment objectives.
Fortunately, the same 42,626 clinician learners demonstrated significant increases in mastery after completing more tailored and effective on-demand training powered by the Ready platform. The ArcheMedX team will present detailed findings at the CNS Summit during Friday’s Poster Session (poster #6) and Saturday’s Innovation Showcase at 2:30pm.
Visit https://www.info.archemedx.com/cnssummit2022 to connect with the ArcheMedX team at the CNS Summit.
Download an advanced copy of “The State of CNS Clinician Readiness” report today and learn more about the Ready platform at https://archemedxinc.wpengine.com/ready/.
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About ArcheMedX
ArcheMedX predicts and improves team and clinician performance, delivering better clinical trials and faster clinical adoption for 21 of the top 25 pharmaceutical firms, emerging biotechs, and nationally recognized healthcare organizations. To learn more about the industry’s leading behavioral learning and predictive analytics platform, Ready, and its impact across clinical operations, medical affairs, and patient care, visit https://archemedxinc.wpengine.com/ or follow ArcheMedX on LinkedIn.
ArcheMedX Releases New Oncology Findings Ahead Of ESMO Congress Revealing Clinician Readiness
2021 was a historic year in the battle to defeat cancer.
More novel cancer treatments became available than ever before with the number of Oncology specific clinical trials also reaching an all-time high, up 56% from 2016 and mostly focused on rare cancer indications.
With global spending on Oncology expected to exceed $300 billion by 2026, the collective investment in new medicines and diagnostics is improving clinical outcomes for millions of patients. Yet, while the pace of investment increases the industry continues to struggle against lengthy R&D timelines.
On-going efforts to streamline the clinical development process advanced throughout the pandemic, but the conduct of clinical research still faces considerable challenges. The growing complexity of trials and increasing administrative burdens in maintaining an effectively trained workforce, especially in Oncology, have been magnified by an acute resource shortage across the clinical research workforce.
Some in the industry see increased eClinical tool adoption as the solution, however, the most recent Society for Clinical Research Sites (SCRS) annual survey reveals that technology is adding an average of 17.5 hours in training per study per site per month at a time that study sites are already understaffed. Coupled with the continued rise in trial complexity as tracked by the Tufts Center for the Study of Drug Development, the IQVIA Institute’s Global Oncology Trends 2022 Report reveals that Oncology had one of the lowest composite success rates among all therapy areas in 2021.
The IQVIA Institute found that research focused on early cancers is challenging because patients are rarely diagnosed early enough to be enrolled in an available study. This recruitment challenge plays a role in the additional complexity and longer study durations Oncology trials have compared to other disease areas, particularly as most Oncology trials are focused on rare cancers today, with two-thirds of trial starts over the last decade targeting developing these novel treatments.
The current approach to equipping clinicians researching and adopting these evolving therapies relies on outdated methods.
Many of the challenges involved in screening and enrolling cancer patients and conducting more complex rare cancer studies cannot be solved solely by technology advancements found in emerging decentralized trials (DCTs), rather they are rooted in underlying performance deficiencies and training gaps. The more complex the study or treatment, the better prepared the study team and clinicians must be.
ArcheMedX has demonstrated a more efficient and effective performance improvement model with major Oncology players, including Astellas, BMS, Daichi-Sankyo, Genentech, Regeneron and others to assess and train over 5,500 clinicians on their emerging therapies and treatments.
And as the annual ESMO Congress approaches this week, the ArcheMedX team has released highly anticipated new findings about how important effective training is for medical professionals researching and treating patients in Oncology.
In assessing 5,500+ clinicians treating Oncology conditions as they engaged in on-demand activities powered by Ready, the ArcheMedX platform identified that over 95% lacked knowledge and confidence in critical competencies before completing more tailored training. Assessment data revealed these clinicians did not demonstrate sufficient proficiency to make good decisions in these emerging areas of Oncology research and practice.
Only 5% of clinicians researching and treating Oncology conditions demonstrated sufficient proficiency to make good diagnosis and treatment decisions.
95% of Oncology clinicians need more tailored training on emerging therapies
These data revealed a surprising number of clinicians were not adequately prepared to genetically test cancer patients, screen them for early studies, and lacked the knowledge and confidence to choose the right treatment plan.
These risks can be reduced by delivering more tailored and impactful education that improves readiness across key research and treatment objectives. Fortunately, these clinicians demonstrated a significant increase in their knowledge and confidence after participating in personalized and highly engaging online training Activities powered by Ready with content provided by Oncology trial sponsors and accredited medical educators.
Clinicians increased their mastery of key learning objectives by more than 8x using Ready by ArcheMedX.
Using Ready to deliver Oncology content improves clinician capabilities
By engaging in more effective on-demand training powered by the Ready platform, clinicians increased their mastery of key learning objectives by more than 400%. In one of many examples, they were now 80% more confident in leveraging genetic testing.
Ready achieves this performance impact by:
- Transforming content (i.e., protocols, study documents, or training materials) into interactive and tailored learning experiences.
- Analyzing clinician engagement and behavior as they learn.
- Measuring changes in learner behavior, knowledge, and confidence.
- Delivering targeted remediation to clinicians on-demand.
- Assessing clinician readiness – to predict and improve clinical performance.
More details about the findings are available for download now or you can request a one-on-one discussion to review these findings in more detail and explore Ready’s capabilities.
ArcheMedX Achieves Data Milestone Modeling Over 25 Million Learning Behaviors
ArcheMedX, a behavioral science-based learning company providing a smarter way to predict and improve clinical team performance, recently passed a significant data milestone.
PRWeb – Charlottesville, VA March 24, 2022
Today, the Company announced its clinician learning and predictive analytics platform, Ready, has now surpassed more than 25 million essential learning behaviors informing its predictive performance models. These models have enabled more than 50 pharmaceutical companies, biotechs, clinical research organizations, and healthcare systems to improve how clinical research professionals and healthcare providers conduct more efficient clinical trials and deliver better care for millions of patients.
“I am incredibly proud of our team and Ready’s growing impact. The predictive performance insights we provide leading healthcare and life science organizations are helping them to optimize the clinical trial process and accelerate the broader adoption of life saving treatments”, said Joel Selzer, co-founder and CEO of ArcheMedX.
ArcheMedX employs a unique behavioral algorithm that measures and models how individuals consume and engage in more interactive learning experiences delivered through the platform. The platform then distills these behavioral data to predict the readiness of staff, teams, and sites to conduct a complex clinical study or to more effectively diagnose and treat a patient with a specific condition.
Added Dr. Brian McGowan, co-founder and Chief Learning Officer at ArcheMedX, “Surpassing 25 million behaviors enables us to broaden our behavioral models, advance our predictive algorithms, and most importantly, accelerate the success of our clinical research partners. It’s a big milestone for ArcheMedX, our partners, and patient care!”
Industry leaders such as Astella, AstraZeneca, Genentech, Merck, Novartis, Otsuka, Regeneron, and Takeda have benefited from the educational impact and behavioral insights Ready provides across dozens of therapeutic areas, including the Company’s recent analysis of 12,000+ clinicians treating CNS conditions. Similar behavioral insights are utilized by global clinical research organizations, such as PRA Health Sciences (now ICON), and an increasing number of trial sponsors to improve team performance and optimize study startup activities.
With Ready, trial sponsors and CROs are accelerating enrollment and preventing downstream risks and delays. Clinical trial leaders are utilizing Ready today to transform site selection and site initiation by predicting and improving the performance of their decentralized trial teams and traditional study sites. As PIs, CRAs, and coordinators consume essential study documents (i.e., protocols, laboratory manuals, etc) and video-based training materials on-demand, Ready predicts their ability to perform their role and provides trial leaders real-time insight to inform faster operational decisions far earlier in the study.
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About ArcheMedX
ArcheMedX enables life sciences and healthcare organizations to better equip, evaluate, and predict team and clinician performance, in order to accelerate the development and adoption of new clinical treatments and best practices. Ready by ArcheMedX is an industry leading solution that provides a smarter way to predict and improve clinical team performance. The platform applies behavioral science to enhance how clinicians and trial team members will apply knowledge and skills in real-world scenarios. Ready then analyzes unique behavioral indicators to reveal areas of readiness and potential risk.
To learn more about our readiness solutions across clinical operations, commercial programs, and medical education, visit https://archemedxinc.wpengine.com or follow ArcheMedX on LinkedIn.
Decentralized trials (DCTs) at Risk, or Ready?
It should come as little surprise that the rise in decentralized trials (DCTs) and increase in study complexities have magnified performance demands across clinical trial teams.
A recent survey by Ernst & Young found 50% of clinical trials will be hybrid or decentralized by 2024. This is welcome news for sponsors and especially patients as DCTs increase patient access and diversity. However, it also means more far reaching, differentiated tertiary endpoints to manage, monitor, train, and evaluate. Together, these changes increase the operational complexity and risk profile of future studies.
Home health staff, caregivers, and patients are now playing more active roles across the study. They are being asked to conduct new procedures and capture more data. This too magnifies risks. Why? PIs at individual sites no longer provide the same level of oversight and environmental control.
For Sponsors and CROs, preparing traditional sites and decentralized teams in a timely, effectively trained, and measurable manner has become a mission critical and increasingly difficult task. As a result, of the roughly 401,898 globally registered clinical studies currently in process, more than 90% will miss key milestones. Even worse, thousands will ultimately fail to meet primary endpoints due to the operational complexity and costly delays that could have been avoided.
Many of the challenges that lead to these delays could be identified far sooner and prevented. To more effectively manage the increased complexity, trial teams must identify the most likely risk areas before patients are enrolled and implement proactive strategies to address them. Thankfully, a growing number of trial sponsors are taking these steps.
The latest ArcheMedX White Paper: DCTs at Risk, or Ready? Assessing the Risks and Readiness of your next Clinical Trial explores these challenges and provides specific guidance for trial sponsors to mitigate risks as they advance clinical research in new and innovative ways.
Click here to download the DCTs at Risk, or Ready White Paper
Meeting the ArcheMedX Team at SCOPE 2022
How can you minimize the performance risks given the complexities of a clinical trial and be ready to effectively conduct your next study?
Pandemic Impact on Clinical Trial Recruitment with Atul Mahableshwarkar, M.D., DFAPA
Atul Mahableshwarkar, M.D., DFAPA, joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss clinical trial methodology. A self-described “trial nerd,” Atul illuminates the make-or-break role methodology plays in a trial’s success and shares his advice and best practices for making positive outcomes possible.
Enjoy this interview by video below, or by subscribing to our podcast on Simplecast, Spotify, or iTunes.
Atul Mahableshwarkar
Dr. Atul Mahableshwarkar is the Senior Vice President of Drug Development at Emalex Biosciences. He is a trained psychiatrist who began his career in clinical practice and academia. Since joining the pharmaceutical industry, he has had the opportunity to learn from both successes and failures in his clinical trial work at companies of all sizes.
Atul shares that early in his career, he was more interested in research than methodology. He credits his colleagues at the time with opening his eyes to the fact that incorrect operations can sink an otherwise viable product. The interest in methodology that that understanding sparked has shaped his career over the last 15-20 years.
Episode Highlights
- The pivotal role of strong methodology in allowing good products to succeed
- Atul’s advice for others beginning to design clinical trials
- What he sees as the greatest challenges clinical trials have in common
- How teams can help motivate clinical trial participation
- Where standard concepts of patient-centricity may be lacking
- How collaboration can help minimize mistakes
- The Orphan Drug and Fast Track designations Emalex has earned from the FDA, and how other organizations can pursue Orphan Drug status
- How the pandemic nearly tripled Emalex’s enrollment
- The importance of supporting sites that may feel threatened by decentralized clinical trials
- The pandemic-enforced recruitment practices he plans to continue
- Key considerations in choosing a preferred ratings scale, and what his is
- Rater training as a misnomer that needs revising
- How to assess and manage raters appropriately
- The value of monitoring data and communicating insights to stakeholders in real time
Resources:
Emalex Biosciences
Atul Mahableshwarkar on LinkedIn
https://isctm.org
https://cnssummit.org
Conversations in Clinical Trial Readiness Interview Series
ArcheMedX Releases New Findings at CNS Summit Revealing Clinician Readiness
The area of clinical research known as CNS (central nervous system conditions) is commonly cited for its complexity and the subjective nature of many assessment tools. CNS clinicians therefore must commit to tackling unique challenges affecting their patients and the research they conduct.
It should be no surprise that the life sciences companies that develop therapies for these conditions prioritize standardization and consistency with their prescribing clinicians.
However, it may surprise you to discover how underprepared many healthcare professionals are to effectively screen, assess, diagnose, and treat CNS patients without the ongoing intervention and educational support provided by these life science companies.
Many of the leading biopharmaceutical companies that develop therapies for CNS, like autism, ADHD, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, schizophrenia, and depression rely on Ready by ArcheMedX to help them better equip, train, and assess the clinicians responsible for the research – and delivery – of these novel treatments.
And as the annual CNS Summit approaches, the ArcheMedX team has released highly anticipated new findings about how important effective training is for medical professionals in these therapeutic areas.
Biopharma companies have used the Ready platform to assess and train over 12,000 clinicians at various stages in the CNS therapy life cycle, including clinical trial start up, market development, and clinical practice.
And across these 12,000+ clinicians, ArcheMedX analyzed their readiness against key learning objectives, as well as their improvement after completing training activities using the Ready platform.
The platform identified that 91% did not demonstrate sufficient proficiency to conduct subjective assessments prior to completing training
91% of CNS clinicians need more tailored training on therapies
These data revealed a surprising number of clinicians were not adequately prepared to conduct subjective assessments in clinical trials, or in practice across CNS therapies.
By assessing more than 12,000 clinicians treating CNS conditions as they engaged in on-demand activities powered by Ready, the platform identified that 91% did not demonstrate sufficient proficiency to conduct subjective assessments prior to completing training.
This risk can be reduced by delivering more tailored and impactful education that improves readiness across key learning objectives. Fortunately, these clinicians demonstrated a significant increase in their knowledge and confidence after participating in personalized and highly engaging online training Activities powered by Ready with content provided by trial sponsors and accredited medical educators.
With Ready by ArcheMedX, clinicians increased their mastery of key learning objectives by more than 10x. In one example, they reduced their misunderstanding about screening and diagnosing CNS treatments by 88%.
Using Ready to deliver CNS content improves clinician capabilities measurably
After completing these CNS specific education and training activities with Ready by ArcheMedX, clinicians increased their mastery of key learning objectives by more than 10x. In one example, they reduced their misunderstanding about screening and diagnosing CNS treatments by 88%.
Ready achieves this impact by:
- Transforming your content (i.e., protocols, study documents, or training materials) into an interactive and tailored learning experience.
- Analyzing clinician engagement and behavior as they learn.
- Measuring changes in learner behavior, knowledge, and confidence.
- Delivering targeted remediation to clinicians on-demand.
- Assessing clinician readiness – to help you identify who is prepared to apply knowledge in the field.
More details are available for download now
Additional details about our findings are available now, or you can request a one-on-one discussion to review these findings in more detail and explore Ready’s capabilities.
Meet the ArcheMedX team at the CNS Summit
Those attending the CNS Summit in Boston, November 7th-9th, can schedule an in-person meeting with the ArcheMedX team. Click here to confirm a time.
Are Virtual SIVs the Future?: Interview with Jennifer Brandl
Jennifer Brandl joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss the feasibility and pros and cons of virtual site initiation visits. A clinical operations expert with a passion for data science, Jennifer shares her experience transitioning from pre-clinical to clinical research and her confidence that data can change the world.
Enjoy this interview by video below, or by subscribing to our podcast on Simplecast, Spotify, or iTunes.
Jennifer Brandl
Jennifer Brandl is the Associate Director of Clinical Operations at Kezar Life Sciences. She has 15 years of experience as a researcher and clinical operations specialist, and she is currently pursuing a Master’s degree in Data Science from the University of Wisconsin.
Jennifer credits her prior experience at a smaller biotech company with giving her a critical foundation in clinical conduct and study execution. At Kezar, she leverages this expertise and her passion for research to support the company’s development of pioneering therapies and to change the lives of patients.
Episode Highlights
- The elements of Jennifer’s expertise that have especially helped her drive success in the trials she manages
- The benefits of functional service provider outsourcing models
- How Kezar’s patient-centric nature had the company well prepared to navigate the COVID-19 pandemic
- The greatest challenges Jennifer and Kezar experienced due to the pandemic, and some positive outcomes
- Important considerations for organizations exploring home health options
- How communication and relationship-building form the foundation of clinical trial work
- The challenges and benefits she’s experienced conducting site initiation visits virtually
- How best to prepare before updating or transforming site initiation processes
- What she believes is next for decentralized clinical trials
- How automation and tech adoption can help extract more insight from data
Resources:
Kezar Life Sciences
Jennifer Brandl on LinkedIn
Conversations in Clinical Trial Readiness Interview Series
