Real-world data (RWD) is defined as data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings.1,2 Analysis of this data generates real-world evidence that, in turn, can generate meaningful insights into unmet needs, interventional pathways and the clinical and economic impact on patients and healthcare systems (Figure 1).1,3
Figure 1. Real-world data driving meaningful insights for decision-makers.
By providing greater clarity on safety and effectiveness, RWD are able to precisely identify the risk to benefit ratio, efficiently demonstrate product value for economic evaluation and maximise return on investment.1 Hence, it is increasingly sought after by decision-makers across all levels of healthcare, from government to the clinic.
Payers are transitioning from transaction-based, fee-for-service to a risk-shared, value-based pay system.1,4 As a result, payers are increasingly demanding RWD to better manage uncertainty around interventions’ safety and effectiveness for approval and reimbursement decision-making.1
Unfortunately, due to inherent limitations with the study design, data from randomised controlled trials (RCTs) are inadequate for demonstrating an intervention’s long-term safety and effectiveness or its generalisability.
Furthermore, there is an increasing need for additional insights on epidemiology, compliance, adherence and costs in a realistic environment, which cannot be obtained through RCTs but by using a number of RWD sources (Figure 2).
Figure 2. Sources of real-world data.2
Despite the increasing reliance on RWD, challenges and limitations exist that complicate the generation, collection and use of this data (Figure 3).
The amalgamation of RWD from multiple sources presents several issues including gaps and inconsistencies in the data arising from differences in the study design and the methodologies for collection and formatting.1 These inconsistencies can also be attributed to disparities in the regulation of RWD collection, use and communication by the biopharmaceutical and medical devices industry compared to other stakeholders.1
Studies generating RWD are considered less statistically rigorous than RCTs with inadvertent biases.1,2,5 Furthermore, there is a significant amount of diversity between geographies with regards to clinical practice and the quality and detail of the data.2 As a result the RWD sets are complicated and difficult to interpret.1
Traditionally, medical consensus on health technologies and clinical practice is developed based on peer-reviewed publication of RCTs, however this process can be slow.1 As the ability of stakeholders to conduct real-world studies increases so too does the pace at which this RWD is generated and this may exceed the rate at which medical consensus is achieved.1
The cost of generating and maintaining RWD is an important limitation, more so for other stakeholders such as patient and professional groups whose funding is less stable and most likely reliant on government bodies.1 Funding of real-world studies may also be affected by issues and concerns with the security and anonymity of the data generated.1 This has not been helped by recent breaches in privacy that have affected patients’ and healthcare professionals’ confidence thus increased their reluctance to be involved in real-world studies.1,6
Figure 3. Challenges with generating robust and usable RWD.1,2
At CRC we understand RWD and its importance in demonstrating product value for approvals and reimbursements. Using our extensive knowledge of and expertise in the drug development lifecycle and the biopharmaceutical industry we can work with you to strategise, design and manage your clinical trials and real-world studies. We can also assist in patient and HCP recruitment by leveraging our existing key opinion leader networks. We understand that effective communication of RWD is essential and our expert team are ready to help you achieve this goal through innovative and strategic publication planning and management.
With the expansion of medical affairs functions across the entire drug development life cycle, what was a fledgling function has since transformed into a core business operation. However, this transformation has led to significant challenges and pressures faced by medical affairs to demonstrate product value and deliver on performance (Figure 1).
Medical affairs face significant challenges
The regulatory environment is becoming more rigorous with increased collaboration between global regulatory bodies.1,2 As a result, drug approval and reimbursements require companies’ medical affairs to generate increasing amounts of complex, real-world patient outcomes data to demonstrate product value.2,3
The expiration of patents for primary care blockbuster drugs has shifted focus towards specialty drugs.4 This has in turn, led to a reliance on medical affairs to provide an increased depth of knowledge in specialty therapy areas. However, this is stifled somewhat by the decreasing percentage of specialists that are able to be accessed by pharmaceutical company representatives.4
The advent of readily accessible medical information has resulted in the evolution of the stakeholder landscape where new and diverse players such as patients and advocacy groups are now becoming key decision-makers.3 Furthermore, demands for transparency and intensifying public scrutiny adds significantly to the compliance pressures already felt by medical affairs to increase credibility and improve stakeholder engagement.3
Medical affairs play a pivotal role in overcoming barriers to accessing healthcare professionals (HCPs). Moreover, compliance requirements mean medical affairs is responsible for providing HCPs with real-time, unbiased and transparent medical information.4
Ultimately, in such an increasingly challenging environment, the onus is on medical affairs to not only generate high level data but to translate this data into quality insights and programs that address the needs of all stakeholders, from patients and HCPs to payers and government bodies.
Figure 1. Challenges in the pharmaceutical industry and the pressures felt by medical affairs.
The value added in outsourcing
Recent trends show an increase in outsourcing of critical functional activities particularly in medical affairs, such as field-based medical teams, medical information and medical publications.1 Outsourcing medical affairs offers companies a flexible and economic solution to meet the growing demands and challenges facing the business.5 Discipline-specific teams with therapy area expertise can be formed on an ad hoc basis. This allows companies the opportunity to shift their headcounts to key initiatives, driven by the changing dynamics within the company and within the market.5 Companies can therefore increase their economies of scale, increase their strategic capabilities and broaden the value proposition (Figure 2), thereby maximising and sustaining strategic management and profitable growth.
Figure 2. Advantages of outsourcing medical affairs.
The CRC advantage and value proposition
At CRC our team of experts with extensive global and local networks allows us to strategise, plan and execute tailored medical affairs projects to unlock the product value at all stages of the drug development lifecycle. This enables our clients to re-deploy their resources to maximise commercial opportunities, thus expediting market access, increasing efficiencies and economies of scale. Our strong strategic presence in the biopharmaceutical industry, high standards of corporate governance and Medicines Australia membership ensure we achieve our client’s goals to the highest quality and compliance.
1 Otto, R., Santagostino, A. & Schrader, U. Rapid growth in biopharma: Challenges and opportunities. (Stuttgart, 2014).
2 Coopers, P. W. From vision to decision Pharma 2020. (UK, 2012).
3 Evers, M. et al. Pharma medical affairs 2020 and beyond. (2012).
4 Systems, V. Reimagining medical affairs: Creating value as stakeholders, commercial models and therapies evolve. (Pleasanton, 2015).
5 Price, B. Medical affairs outsourcing. (Titusville, 2013).
Clinical Research Corporation (CRC) was recently featured in the latest edition of Logolounge.com. LogoLounge presents the best logo designs in the past year from around the world, as judged by a select group of top designers.
“Our company’s unique and innovative service offering is re-defining Medical Affairs for our Pharmaceutical clients, with true strategic partnerships to help them achieve their specific objectives. Our tailored solutions provide fresh new insights from pre-launch through to commercialization and beyond.” Jimena Hurtado, General Manager of CRC Australia.
Emedia Creative reflected the company’s unique business model by using the bespoke CRC ‘pill’ icon which symbolises the beginning of a revolutionary dialogue and approach. The inverted, high contrast, monochromatic lab images support CRC’s approach of seeing problems ‘differently’.
CRC provides Medical Affairs solutions to the Pharmaceutical industry throughout the Drug Development Life Cycle. Our objective is to maximise the value of therapeutic compounds from pre-launch through to commercialisation and beyond.
© Copyright 2017 Clinical Research Corporation. All Rights Reserved.