What is real-world evidence and why is it useful ?
Real-world evidence can improve healthcare in a broad diversity of ways , from simply improving the knowledge on treatments , to identifying organisational issues in healthcare systems that may have big budgetary and health impacts
Jean-Marc Frybourg Senior Consultant , Inbeeo , London , UK
Shane Horgan Scientific Analyst , Inbeeo , London , UK
The concept of real-world evidence ( RWE ) in healthcare has been a growing trend over the recent years as the applications for its use have expanded to cover additional stakeholders and stages of a product ’ s lifecycle . But what is RWE ? RWE is simply defined as evidence derived from real world data ( RWD ). 1 RWD is a broad term which relates to data collected outside of randomised controlled trials ( RCTs ) 1 and therefore encompasses a wide range of sources . Data collected from health records , consumer data , social media , registries and claims databases can all be considered RWD .
Most post-market authorisation studies ( referred to as Phase IV ), most pharmacovigilance studies , registries and the field known as pharmacoepidemiology have all been undertaken for years and are based on real-world data . Traditionally , the use of RWE was important in the regulatory space in the post launch setting where its principle use applied to pharmacovigilance – ensuring postmarketing regulatory commitments were met . 2 RCTs look at the effectiveness or safety of a drug – or other medical intervention – by controlling variables , therefore they are indispensable in order to understand if a drug works . But only RWE will show if under less-controlled settings these outcomes are influenced by all variables that in real life are not controllable . On the other hand , RWE does not allow for the evaluation of a drug or other treatment options but rather the evaluation of a whole treatment approach . Thus , we can learn whether treatments are applied correctly or efficiently . Such observational conclusions cannot arise from RCTs . RWE and RCT complement one another and do not replace each other .
The value of RWE for physicians RWE delivers lots of value for physicians and physician organisations . As RWE delivers information on the various outcomes of treatments administered in routine care and on various patient subpopulations , the learnings are precious to refine their practice and better choose which treatment should go to what type of patient , and for drugs also with the right application and dosage , etc . It does not mean that personal experience and evidence from RCTs have no value . RCTs are an indispensable basis ; however , they do not answer all questions while a lot of them can be addressed with RWE . Personal experience can be confirmed – or modified – by scientifically convincing RWE . In addition , RWD can increasingly be generated in routine practice in real time , with phone apps , wearables or electronic devices , which opens many opportunities for treatment adjustment , treatment adherence improvement , telemedicine , etc . Besides its value for patient care , physician organisations can leverage RWE for advocacy purposes . RWE is the tool of choice for measuring quality of care , and for identifying issues stemming from disease management practices , or from the organisation of care for a given disease , or from the inadequate ( excessive or insufficient ) resources to address it properly , etc . Thus , it provides factual evidence that can feed constructive dialogues between the various stakeholders interacting with physicians such as sick funds ( payers ), hospital management , pharmacists , country health authorities , professional or scientific societies . As an example , it is easy to detect with RWE whether a seemingly excessive average dose of a given antidepressant in a population is justified or not , because it may very well come from psychiatrists ’ prescriptions to more severe patients while other practitioners prescribe much lower doses to mild and moderate cases . In this example , a simple RWE study allows for informed decisions whereas payers might have been tempted to take bad restrictive decisions . For physicians , the possibilities of leveraging RWE for various purposes is endless .
RWE for patients Patients and patient advocacy groups benefit as well from RWE . Firstly , as RWE delivers additional evidence on a wide diversity of endpoints , it allows patients to receive better and more personalised care . In other terms , when physicians benefit from learnings coming from RWE as already mentioned in the previous section , and patients benefit in turn from improved care . Moreover , as RWE is incorporated in health education programmes , those patients willing to learn about their disease directly benefit from RWE as it improves the quality of their dialogue with healthcare professionals ( HCPs ) which in turn allows for higher quality decisions about their condition . They can also better manage their own lifestyle , which may be facilitated by apps and wearable electronic devices . Besides individual patients , RWE provides critical factual evidence to patient groups . With it , they can advocate with authorities for addressing access or economic challenges and point out healthcare organisational issues related to the management of their disease . For example , burden of illness studies are particularly useful to highlight gaps in resources to properly care for the full patient population , or the improper distribution of healthcare resources across types of healthcare interventions , or geographies , etc . Lastly , patients can easily contribute to research on their own condition when actively participating in RWE studies . hospitalpharmacyeurope . com | 2021 | 3