Real World Evidence

Delivering Real World Evidence...

because clinical trials only get you so far

Experts in RWE generation

Real world evidence studies answer the question frequently asked by payors: ‘How do real patients perform on the medicine?’

This is in contrast to the randomised controlled trials, mandated by the regulatory bodies before a product is granted marketing authorisation, which are designed to answer the question: ‘Does the medicine work?’

The next question usually asked is: ‘How much more cost-effective is this medicine compared to the ones we already have?’

Delivering Real World Evidence... because clinical trials only get you so far.

Delivering Real World Evidence... because clinical trials only get you so far.

Medialis recognises the challenges of in-house delivery of medical affairs projects, offering a complete Intelligent End-to-End Medical Affairs delivery vehicle.

Medialis ensures the right strategic asset is generated for the right reason...communicated in the right way.
We can help you... visit us www.medialis.co.uk

Becoming pragmatic about the value of Real World Evidence

by Áine Dillon

Back in the mid 90’s, when I started out in the world of clinical research, there was a certain hauteur associated with working in Randomised Clinical Trials (RCTs). RCTs were the Theoretical Physics of the Natural Sciences. As for studies in the peri-approval/ post-authorization area…well you might as well have been counting pollen grains under a microscope. Roll on two decades and due to the competitive nature of health markets, determining safety and efficacy through RCTs is no longer sufficient, in isolation, to win market access. So, time to climb down from the ivory to tower, roll up those sleeves, and fully embrace the world of Pragmatic Clinical Trials (PCTs). Of course, the PCT concept is not new, having been introduced over half a century ago in the seminal paper published by Schwarz & Lellouch [1].  Pragmatic trials aim to measure the relative effectiveness of treatment strategies in real world clinical practise. Pragmatic and explanatory trials (which measure efficacy under ideal conditions, such as typical phase 3 RCTs) represent ends of a continuum rather than distinct entities (Thorpe et al, 2009)[2].  So why the need for PCTs? For most new market-approved treatments, the clinical evidence (mainly phase 3 RCTs) is still insufficient to fully guide clinicians and policy makers in choosing the optimal treatment for their patients. Pragmatic trials can help supplement this data with Real World Evidence (RWE).Non-Interventional Studies (NIS) such as Observational Studies & Patient Registries can also provide valuable RWE. They differ from PCTs, in that there is no randomisation used to assign a patient to a particular therapy. No additional diagnostic or monitoring procedures are applied to patients and epidemiological methods are used for the analysis of the collected data. In a recent report in the Economist Intelligence Unit[3], on the findings of a quantitative study conducted around drug development and market access, adaptive trial designs, patient-centric trials, precision medicine trials and real-world data trials consistently deliver against industry success criteria.

References:

1.Schwartz, D. and Lellouch, J.Explanatory and pragmatic attitudes in therapeutical trials.J Chronic Dis.1967;20:637–6482. Thorpe, KE; et al. (2009), “A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers”,J Clin Epidemiol,62(5):464475,doi:10.1016/j.jclinepi.2008.12.011,PMC26798243. https://druginnovation.eiu.com/

RWE in the Middle East and North Africa (MENA) region

by Jesica Levingston Mac Leod

The high incidence of rare diseases in the Middle East and North Africa (MENA) region is only one of the reasons why companies are looking into this area to expand their portfolios. The area includes the following countries: Algeria, Bahrain, Djibouti, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Malta, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates, West Bank and Gaza, and Yemen. Ethiopia and Sudan are sometimes included, to account for a total population of over 400 million people.

Some interesting characteristics of the region are the share languages, religions and activities across borders. For example, the shared Arabic language and some holidays, such as Ramadan, might offer a similar management across countries, which facilitates the generation of RWE.

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