Real-world evidence (RWE) demonstrates long-term effectiveness and safety beyond the efficacy and tolerability shown in randomized controlled trials (RCTs) and is derived by analyzing real world data (RWD). With the increasing requirement for RWE by regulators, prescribers, and payers to inform decision-making and pricing, pharmaceutical companies are conscious of the need to ensure organizational fluency in the terminology and methodology of RWE generation. Interactive learning techniques to achieve this were described at ISPOR Europe 2018.
A mobile poll about the RWE experience of the symposium audience revealed that:
- 22%, 27%, and 35% had a lot, some, or a little experience working with real-world research, respectively; 16% had no experience
- 16%, 47%, and 27% said it would be extremely challenging, challenging, or somewhat challenging to advance an RWE agenda within their organization, respectively; only 11% said it would not be challenging
Audiences within an organization have differing expertise and training needs
Raising organizational fluency in RWE
Traditionally internal corporate communication, education and learning design has taken a passive information-providing one-size fits all approach, said by David Thompson, Vice President, Real World Evidence, Syneos Health. However, audiences within an organization are heterogeneous with different levels of expertise, training needs, objectives and uses for the subject matter — one-size does not fit all.
Interactive training approaches tailor content and learning experiences to unique learner needs. Traditional passive learning techniques are replaced by learner-driven interactive choices; and skill building and application practice replace the provision of information, explained Dr Thompson.
Organizational fluency enables conversations between all stakeholders
The aim is to raise organizational fluency — a deliberate term to indicate that the training is not to improve understanding but to enable conversations between stakeholders with all levels of experience and expertise.
A strategy to elevate and integrate RWD and RWE
Until relatively recently, RCTs have received the large budgets and been carefully planned, in contrast to RWE, which has treated more as an afterthought, said Claire Methven, Global Real World Evidence Lead, Education and Training, Janssen. However, the importance of RWE is increasingly recognized, and a strategy to elevate and integrate RWD and RWE was initiated by Janssen in 2014.
An initial assessment of the organizational training needed to implement the strategy revealed pockets of expertise, inconsistent terminology, lack of planning, non-transparent data sources and limited best-practice sharing, said Claire. A mobile poll of the symposium audience revealed that these characteristics are features within other organizations too.
Interactive training can convert pockets of expertise into a powerful network
It became clear that to move forward, RWE would have to become an integral part of the business and to do this it would be necessary to change mindsets, behaviors, processes, and capabilities, explained Claire.
Build a platform, connect a network, change a culture
Interactive training can convert pockets of expertise into a powerful network, replace inconsistent terminology with a broad consensus on definitions, provide a central resource for data sources, and enable practice sharing through case studies and lessons learned, explained Yvonne Ash, Vice President, Learning Solutions, Syneos Health.
Interactive training can ensure consistent terminology
The first step is to assemble a dedicated and diverse team with expertise in medical affairs, health economics, epidemiology, analytics, global regulatory affairs, regional RWE, IT data sciences, medical device evidence generation and scientific affairs, Yvonne said.
The next step is to create a one-stop central resource with different tracks and plenty of videos and interactive tools:
- to provide awareness for those who do not work in RWE to enable understanding of RWE conversations — for example, explanations of the terminology
- to inform those who make decisions related to RWE such as project leads
- to address RWE generation for those generating RWE such as statisticians and epidemiologists
Interactive training can enable access to a central data resource and practice sharing
Resources included in the central resource might include articles, announcements, regional RWE information, best practices and case studies, regulatory updates, data sources, events, toolkits, and a chatbot. It is also important to include a mechanism for continuous improvement to enable further development of the platform, advised Yvonne.
This educational session was sponsored by Syneos Health