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Blog
Generating RWE When the Healthcare System is Overburdened
Calum Neish, directeur principal, développement des affaires, RWS
Apr 22, 2020
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  • Generating RWE When the Healthcare System is Overburdened

Update Oct. 7, 2020

During the first wave, of the COVID crisis, we learned that social distancing and lockdown measures posed significant challenges to recruitment and on-time initiation of site-based studies. As we head into the second wave, it is even more imperative to develop strategies and effective solutions to ensure the generation of robust RWE even amidst this pandemic.

The following article, initially written in April of this year, presents an approach to using secondary data sources to support research. With the second wave of the COVID-19 infection threatening to reinstate lockdown measures and re-enforce strict rules on social interactions, the use of Database Studies to conduct research is as relevant as ever. This approach can provide study sponsors with a viable approach to continue Real World studies if researchers and healthcare sites need to bring back tougher restrictions on research to manage the ongoing uncertainty caused by the pandemic.

 

During these unprecedented times, when the global healthcare system is dealing with the COVID-19 pandemic and resources are being redirected to support frontline care, access to researchers is more restrictive. Meanwhile, social distancing and physical distancing restrictions put in place for the safety of our communities mean that patients are only visiting their physicians when necessary, resulting in disruptions or delays to ongoing, non-priority studies.

However, the need for Real World Evidence (RWE) continues to be a critical component of decision making, despite the current challenges in conducting site-based research.

Healthcare stakeholders and decision makers are increasingly relying on evidence derived from Real World Data (RWD) to guide and help influence decisions ranging from regulatory approval, to reimbursement, to treatment decisions in the clinic. 

Prior to the current situation, there had already been a gradual paradigm shift in favour of reviewing drug effectiveness and safety earlier in the product lifecycle to facilitate access to medications in an expedited fashion, particularly for rare disease and oncology.

The challenge of site burden is not a new issue. With an average of 54 new active substance launches each year globally, and the implementation of cost containment measures, the need to differentiate from competitors is increasingly important. Site-based RWE studies can be time consuming, costly, and involve a high degree of administrative burden. This latter factor has already been shown to be critical in researchers’ willingness to participate in these studies.

During times when sites are overburdened, DATABASE STUDIES provide an effective way to generate Real World Evidence, without the need for in-clinic interactions with researchers, HCPs and patients.

Database studies can be broadly grouped into the following categories: 

  • External comparative data
  • Epidemiology assessments
  • Drug utilization
  • Effectiveness and safety
  • Healthcare resource utilization

Typical sources for database studies include: pharmacy prescriptions, public and private payer claims, administrative or billing data, diagnostic or lab data, electronic medical records (EMR), and patient support programs (PSP).

The data derived from these databases provides a large quantity of analyzable patient-level RWD, which are often generalizable to the population. As the data pre-exists and site staff are not required, databases are often easier to access and reduce the burden on the healthcare system to collect the data.

It is important to note that no single database contains all the information required to answer the multitude of RWE questions. Any given database is likely to contain incomplete information, e.g. there may not be information on diagnosis, disease stage or severity may be lacking, there may be geographical or store coverage issues, or there may be gaps in patient-level coverage. 

In order to generate accurate and reliable evidence, it is important to reduce study bias and confounders when designing database studies. This means understanding several critical factors:

  1. What data is collected and/or is available
  2. Why the data is collected
  3. How the data is collected
  4. What information or variables need to be inferred
  5. When and How databases can be linked
  6. How to interpret results

The IQVIA Real World Solutions (RWS) team is well positioned to support your evidence generation with our Database Studies.

The ability to access large, national patient-level RWD assets in Canada is foundational to conducting a successful database study. Knowing what databases exist, who owns them and the gaps that exist in the information will determine the success of this approach. The IQVIA RWS Team has direct access to pharmacy dispensations, payer claims, and primary care electronic medical records, in addition to over 150 collaborations with external data sources.

Our team of local Data Scientists are well-positioned to provide you with an innovated approach to your RWE generation. We operate in a ‘Pod’ structure, using a matrix-decentralized approach, which encourages knowledge continuity and provides our clients with an agile and responsive delivery. We are governed by specific SOPs relating to database studies to ensure quality deliverables while maintaining privacy and compliance of patient-level data.

For more information on Database Studies, visit our website at www.iqvia.com/canada/rws. To talk to our team about your organization’s needs, contact us.

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