Generating the outcomes that matter

SVMPharma LtdLandmark HouseStation RoadHook, HampshireRG27 9HA

www.svmpharma.com enquiry@svmpharma.com

For those of you who are new to Real World Evidence (RWE), we start with a brief refresher:RWE is clinical data collected outside of a conventional randomised controlled trial (RCT). RWEoffers a number of advantages compared to RCTs, being more representative of a real-lifepopulation, better demonstrative of the benefits of a drug in everyday clinical practice andmore valuable in covering real-life patient behaviour and adherence.

Over the last 2-3 years the role of RWE in the pharmaceutical industry has transformed,catching the attention of pharmaceutical companies, advisory bodies, regulators and more.RWE has become an indispensable way of supplementing RCT data and bridging data gaps.

RWE programmes continue to generate commercial and clinical outcomes at an increasing rate,including successful health technology submissions, market access and growth, service re-design and peer-reviewed publications.

Although much has been written and

said about RWE, the focus has been

primarily on the data.

However, the key to the ideal Real

World Evidence programme is the

foundation supporting it- which we

believe to be the intelligent use of

Technology and sustained

healthcare professional (HCP)

Engagement

Let’s examine how this can work:

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What do you want to achieve with your Real World Evidence?

What if you could get out of it more than you imagined?

Would you be willing to try something a bit different?

Let’s see if there is a better way of achieving and even surpassing your RWE objectives….

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RWE data collection is a different experience to conventional clinical trials, and allows muchgreater freedom for engaging with the healthcare professionals (HCPs) and the centres takingpart. Here at SVMPharma we promote this aspect as an essential part of the project, and itbecomes integral to maximising the outcomes in multiple ways. From the moment the project iscommissioned, key HCPs are selected, and are consulted as to the design of the project andtheir extensive experience used to determine what data are available, where the data areavailable, and what data are required.

The collection parameters are chosen based on extensive input, validation and guidance fromHCPs and a steering group is established and consulted where there are challenges andunexpected obstacles. Encouraging the HCPs to take an active part in the project has a numberof benefits. Three key benefits are:

1. It cultivates and grows the relationship with prescribing centres and key opinion leaderswithin the speciality.

2. It adds expertise and experience to the project to help with problem solving.

3. Selected lead HCPs are involved in the congress abstract, poster presentation, and anyensuing journal publication, adding weight to the project and its findings.

SVMPHARMA & HCP ENGAGEMENTSVMPharma have a proven record of successful HCP engagementwith projects designed around this as a central factor. We haveexperience of working with over 100 HCPs and NHS trusts on RWEprogrammes within multiple disease areas. We have a network ofkey opinion leaders in specialist areas from our previous projectsand utilise the client’s existing connections. We offer value to thecentres via personalised reports and promote a publication planthat recognises the work of the HCP and the centre. We prideourselves on a close working relationship between the client, theHCPs, and ourselves.

Steering group of HCPs consulted as to design of the project and data collection parameters

HCPs kept informed throughout project

and their experience utilised

HCPs take active role in presentations and

publications

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Technology and data go hand-in-hand, for example, advancements in processing and storagecapabilities allow data management at a level previously unimaginable. But more than being anenabler of data collection and management, how can else can we use technology intelligently tomaximise outcomes?

We introduce the SVMPharma Real World Treatment Evaluator. This is the centrepiece of ourRWE programme and is a web-based database custom-built for each project.

The Real World Treatment Evaluator has a number of features that address the challengesunique to RWE data collection, and provides an efficient and expedient method for data input,management, validation, and output.

For RWE data collection, data are collected from a range of selected treatment centres. Webelieve that the most effective and efficient process is for data to be input by healthcareprofessionals at each individual centre. The user interface accommodates for users withdiffering levels of technical and medical expertise and a varying extent of familiarity with thepatients. This could be the lead HCP themselves, or other doctors, nurses, and datamanagement staff in the department.

The user accesses the Real World Treatment Evaluator through a secure custom URL, accessiblefrom a web browser, and receives training and support in using the system. Data are enteredfrom patient records and is pseudonymised. The majority of questions in the treatmentevaluator are either yes/no or multiple choice with open questions avoided. The careful designof the questions in conjunction with expert advice allows the data to be input in a format that iseasy to manage, consistent, efficient and generates a ‘rich’ dataset without gaps.

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The Real World Treatment Evaluator offers guided data input taking into account issues specificto the particular disease area, and include baseline data, details at different time points (e.g.patient reviews), and disease progression details- essentially any information within the patientnotes.

This system deals with one of the major shortcomings of real-world data, the lack of consistencyin how data are organised and stored across different centres. Data input into the real-worldtreatment evaluator can be tracked with a live update of the progress towards targets, and withboth manual and automated checking of discrepancies. Additional centres can join theprogramme at a later date if required to boost the dataset. In-built analytics and reportingprovide instant aggregated reports and can provide valuable additional information that helpsrefine and adapt the data input process. Data extracts can be taken at any time and the outputscustomised in the format required e.g. for health economic modelling.

SVMPHARMA & TECHNOLOGYSVMPharma are a subsidiary of a global technology solutions powerhouse,with access to market- leading technology and a substantial team ofdevelopers, programmers, programme testers and data managers. Thisallows us to fully customise and scale the real-world treatment evaluatorto specific needs and deadlines and provide unmatched technical supportthroughout the programme.

www.svmpharma.com

©2016 SVMPharma Ltd. All rights reserved

SVMPharma is an innovative strategic consultancy, specialising in Real World Evidence (RWE)for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe throughbespoke online Real World Treatment Evaluators, leading to successful health technologyappraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinicalpractice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’sspecialist teams focus on delivering the outcomes that matter to your brand. SVMPharmaalso provides Global RWE, Patient Real World Outcomes, and Big Data Analytics.

To find out more call +44 (0) 1256 962 220

If you are considering a RWE project, you are about to take a step in the right direction,

RWE data collection has a lot to offer and can only enhance your commercial outcomes.

However, there are different ways of collecting RWE, and if you make the right choices, you

can go further with your data. Supporting your RWE data collection with the intelligent use

of technology and sustained HCP engagement ensures that you will be in the best possible

position going forward.

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