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Case study: From Clinical Trials to Real-World Evidence

Convening to share experiences of real-life use of common therapeutic solutions

Published: 13 Jan 2018

Clinical trials RWE

Client: Janssen

Agency: Havas Life Medicom

Campaign: From Clinical Trials to Real-World Evidence

Timescale: N/A

A quick look

Clinical trial data does not provide comprehensive information on a drug. A product in a new therapeutic area lacks robust, convincing evidence for doctors to make informed clinical decisions.

Real-world evidence should not be underestimated in its importance to inform therapeutic decision-making, while also informing about a product’s potential use in additional indications. In April 2016, 120 dermatologists, rheumatologists and gastroenterologists were engaged in a truly collaborative environment to share experiences of real-life use of common therapeutic solutions.

Challenge

While clinical trials remain the gold standard for drug approval, the healthcare ecosystem requires more information than ever before on how specific drugs work in real-world, clinical practice environments, in particular for patients that would be excluded in clinical protocols, eg due to pregnancy and co-morbidities. However, some stakeholders can be resistant to utilise the data gathered in real-world studies due to their observational nature.

With the impending launch of Product X for a new indication in gastroenterology, it was important to be able to build
on Product X’s real-world experience and heritage within dermatology and rheumatology, since these diseases share a common inflammatory mediator targeted by Product X. However, a targeted survey sent to clinicians suggested that real-world evidence (RWE) had less impact on healthcare decision-making than clinical trial data.

Solution

Excellence in medical education

The PEARLS medical education programme is driven by a Steering Committee of leading experts to deliver quality medical education; established with over 10 years of successful events, it has captured the attention of over 10,000 participants. This commitment and inherent value of the PEARLS programme has allowed us to leverage a wide breadth of experience and run a highly scientific and innovative meeting.

Cross-speciality networking

120 gastroenterologists, dermatologists and rheumatologists convened in a three-day cross-speciality meeting in order to drive insight sharing from knowledge of clinical data and real-life experiences in using Product X. Through collaborative, cross speciality workshops and plenary presentations, delegates had the opportunity to work together to examine the registry data within their own therapeutic area, as well as viewing the benefits of Product X through real-world data from other indications. Informal networking spaces were provided to drive collaboration, and a graphic artist created interpretations of the key messages to create memorable learnings and aide-memoires for delegates.

Challenging current beliefs

The kick-off debate discussed the merits and drawbacks of RWE and clinical trial data. This set the tone for the meeting and provided a way to shift belief among attendees right from the start. Interactive tablet devices allowed delegates to put forward their comments and vote on important topics, ensuring a continuous dialogue. Speciality-specific sessions enabled doctors to analyse learnings from other areas with experience of Product X and discuss how these learnings could be applied in their own clinical practice, driving the importance of utilising registry data.

Results

A belief shift in HCP opinion was reinforced: an average score of 8.6/10 was given to rate the impact of the meeting content on attendee clinical practice, with 72% of attendees ‘strongly agreeing’ that they would recommend the event to a colleague.

Best practice in delivering excellence in education: the European Accreditation Council for Continuing Medical Education (EACCME) awarded the meeting a total of 8 European CME credits (ECMEC) - the maximum available.

Driving collaboration and knowledge: take-home learnings that were most cited included checking RWE data more frequently, counterchecking statistics for bias, combining data from dermatologists and appreciating the impact of registries on care.

Client verdict

“This was a truly successful meeting with a strong engagement from all participants. The Scientific Committee supported by Havas Life Medicom shaped a relevant and robust educational programme, ensuring delegates were able to take valuable insights into their own clinical practice. There are many lessons to be learned from other specialities, and looking at real-world evidence is key to improving patient outcomes.” Peter Robinson, Medical Education and Scientific Relations leader, Janssen Immunology

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