Getting life-enriching drugs to market faster.
PES increases chances of clinical trial success by driving clinical trial endpoint accuracy, consistency, and quality.
Delivers study-specific training to doctors, nurses, and site staff on the conduct of complex endpoint assessments
Objectives
Assure consistency, accuracy, and concordance of clinical endpoint assessments among assessors and study sites
Introduce contemporary e-learning techniques to increase learner engagement and knowledge retention
Extend training breadth and depth of training curriculum
Results
Helps pharmaceutical companies improve accuracy while minimizing the sample size, accelerating FDA approval, and speeding drug time to market
Delivers training consistency and efficiency across 13 geographic markets
Reduces cost of training worldwide by 20%
Proving efficacy of new treatments
Pharmaceutical companies depend on efficient, well-executed clinical trials to get promising drugs to market faster. To gain U.S. Food and Drug Administration approval, they need to demonstrate how their medications compare to existing medications for the same condition. This is typically achieved through randomized, double-blind studies involving thousands of participants, conducted over many years to examine a medication’s long-term side effects and overall safety.
Primary Endpoint Solutions (PES) was founded because many clinical trials needlessly fail. This can happen for several reasons, such as when test results cannot be replicated, expected efficacy signals are not obtained, or there’s too much variation between site results.
These types of failures often result from inconsistent data collected during a trial — data that should specifically point to the trial’s goals or endpoints. Defined as a measurable outcome to determine whether the studied intervention is beneficial, an endpoint could include survival, quality of life improvements, symptom relief, or — in the case of cancer — tumor disappearance.
To address these objectives, PES works with pharmaceutical companies to improve the quality and consistency of endpoint data gathered during a trial. Accomplishing this involves training everyone involved in administering the trial, including doctors, nurses, and site staff at hospitals and clinics.
“Adobe offered the strongest LMS to meet PES goals. As a longtime user of Adobe applications, I knew Adobe Learning Manager would be robustly supported by Adobe’s industry-leading service.”
William Diehl
Distance Education Consultant, Primary Endpoint Solutions
Embracing online training
PES saw an opportunity to leverage the power of online training for clinical trials and decided to standardize on Adobe Learning Manager as its global learning management system (LMS).
“I recommended Adobe Learning Manager following an extensive review process,” says William Diehl, a consultant to PES and founder of Pongid, a distance education consultancy. “Adobe offered the strongest LMS to meet PES goals. As a longtime user of Adobe applications, I knew Adobe Learning Manager would be robustly supported by Adobe’s industry-leading service.”
Diehl — an acknowledged LMS expert who is also an associate editor of the American Journal of Distance Education — admired the clean, modern, and intuitive interface of Adobe Learning Manager. He also recognized its synergies with Adobe Captivate, an authoring tool that can be used to embed video, animation, and interactive quizzes into training modules. Scalability was also a factor because PES provides training for trials on five continents.
Moreover, Adobe Learning Manager supports the rigorous documentation required for regulatory compliance. Through the platform’s data transparency, PES managers can monitor and chart every learner’s performance in real time as they progress through the curriculum, issue certifications, and track to completion. This process helps ensure all site staff have the proper training.
Building clinical trial knowledge
To date, PES has used Adobe Learning Manager support six major clinical trials. Currently, the platform hosts 28 online training courses and approximately 1,000 learners annually across Australia, Belgium, Canada, the Czech Republic, France, Germany, Poland, South Africa, South Korea, Spain, Switzerland, the United Kingdom, and the United States.
Each course contains between two to seven self-paced modules that provide learners with an overview of the trial, the biology behind the therapy and investigational drug, and detailed instruction on how to conduct oral examinations and record findings that directly contribute to the trial’s primary endpoint.
To achieve certification, participants must pass a quiz at the end of every module. A 100% score is required before progressing to the next module. If questions are answered incorrectly, learners must review the relevant information and then take the quiz again until they pass.
“Before implementing online learning, participants’ knowledge retention tended to decline four weeks following training,” explain Diehl. “Today, however we have the courses readily available 24/7 and participants can review them as much as they want to ensure high accuracy in their clinical trial assessments. The courses offer excellent pacing, high-quality graphics, and are narrated in a friendly tone, which increases learner engagement and retention.”
“Adobe Learning Manager has driven a significant improvement in clinical endpoint accuracy and quality. It’s helped establish PES as a leader in clinical trial services and is bringing hope to hundreds of thousands of people per year by delivering new medications to market faster.”
William Diehl
Distance Education Consultant, Primary Endpoint Solutions
Accelerating new drug approval
Since deploying Adobe Learning Manager, PES reduced training costs by 20%, with most savings coming from eliminating travel. “Online training, if done well, can be more effective than a face-to-face modality,” explains Diehl. “In addition to the cost savings, online training eliminates the challenge of coordinating meeting times and dates across multiple learners.”
Diehl also reports that Adobe Learning Manager performance has been outstanding. “The platform has depth and complexity, yet it is a learner-friendly platform, which cuts down on learner support issues. As well, there have been no technical service issues with Adobe Learning Manager to date. That’s impressive.”
PES training is now delivered uniformly across 13 countries. It has led to unprecedented consistency in how site staff conduct trials, from how they complete forms to how they administer medication.
Doug Yoon, MD, PhD, MPH, offers a perspective from pharmaceutical trial sponsors. “Adobe Learning Manager provides PES a systematic learning platform that offers everyone working on clinical trials with compelling content including visual cues like charts and graphs,” he says. “It supports our desired outcome to introduce a treatment for cancer patients.”
Reflecting on the success of the Adobe LMS implementation, Diehl notes: “Adobe Learning Manager has driven a significant improvement in clinical endpoint accuracy and quality. It’s helped establish PES as a leader in clinical trial services and is bringing hope to hundreds of thousands of people per year by delivering new medications to market faster.”
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