Pulse Infoframe specializes in generating real-world data (RWD) that can be used to create real-world evidence (RWE). In this article, we will discuss how pharma companies can access real-world evidence for drug development, starting with RWD collected through our healthie™ platform.
How Does Pulse Infoframe Obtain Real-World Data?
Pulse Infoframe specializes in collecting RWD through healthie™, our flagship evidence generation platform. The RWD then becomes the necessary foundation for evidence. healthie™ provides the infrastructure to add disease-specific natural history, genomics, proteomics, and third-party data in a manner that abides by global security and privacy standards (we are both HIPAA and GDPR compliant) and ensures data quality.
Supporting Endpoint Development With Custom Validated Instruments
Thanks to a partnership between QualityMetric and Pulse Infoframe, opportunities now exist for pharma companies to collaborate with key stakeholders to create new validated instruments that can support endpoint development for trials and regulatory review. These instruments include severity scales for staging and outcome measures and integrate seamlessly into healthie™, enriching even further the RWD that our platform already collects.
Real-World Evidence Use Cases That Support Drug Development
Dr. Femida Gwadry-Sridhar, our founder and CEO, developed healthie™ to remove data siloes that are preventing researchers, including those in pharma, from finding treatments to better patients’ lives. Using real-world data to generate RWE can help your company find answers to questions relevant to drug development, funding requests, and IRB approval. Here are some questions whose answers may be supported by RWE already found in healthie™:
- Is there RWE that can support approval of your drug in a novel way or setting?
- How does your drug affect patients outside of clinical trials in terms of safety and efficacy?
- Does RWE suggest that your drug is more effective than clinical trials demonstrated?
- Is there enough relevant evidence to apply for public funding for treatment?
- Do results from clinical trials apply outside the trials?
- Does a synthetic control exist for the study you wish to carry out?
- How long after approval do doctors begin prescribing a drug?
What Standards Do the Data Meet?
Many organizations, including patient advocacy groups, pharmaceutical companies, and academic and research centers, use healthie™ to generate data and evidence that are regulatory-grade ready. Data that meet these standards are mapped to the Observational Medical Outcome Partnership (OMOP) and can be read into mCODE and CDISC. When combined with a defined data dictionary (a standardized glossary of term and vocabulary), this ensures that research methods can be systematically applied to produce meaningfully comparable and reproducible results.
Discovering Real-World Insights Using Artificial Intelligence
The healthie™ platform provides a built-in suite of analytical tools that can provide traditional statistical measures from the underlying patient registry data without extensive data export and import, consolidation with other sources, or manipulation. Instead, a well-designed, easy-to-use graphical interface allows biostatisticians, epidemiologists and other medical researchers to select data elements of interest and generate classic visualizations and biostatistical measures inclusive of descriptive statistics.
However, should a deeper analysis be needed, we offer a full suite of advanced analytics and artificial intelligence (AI)/machine learning technologies. This has been made possible through a global partnership with Quinten Health in France. You can find more information on this health informatics partnership here.
How Can Pharma Companies Access Pulse Infoframe’s Real-World Data and Evidence?
Pharma companies can access Pulse Infoframe’s RWD and explore the evidence in a variety of ways:
- Direct access to healthie™: de-identified data through a secure portal to explore cohorts
- Reports: request a summary based on epidemiological questions of interest
- Studies: design a retrospective, prospective or ambispective study that leverages both the data that are collected as part of a registry or leverage our investigator network for observational longitudinal studies
We’ll cover each option in the following sections.
Direct Access to healthie™ for RWE Research
This option is available to pharma companies with in-house experts who can create fully configurable queries into de-identified platform data to enable the following:
- Creation of customized visuals
- Data mining and cohort exploration within diseases and conditions
- Discovering trends over time
Accessing Real-World Evidence via Reports
A report is an overview that answers several of your questions to better understand the subject you’re investigating. For example, our Global Melanoma Registry Network is a 10-year observational study that continues to grow. Pharma companies working in these areas have been tapping into this wealth of RWD to answer specific research questions that, for example, investigate the prevalence of different patient populations or frequency of treatment type used in-clinic.
Our reports will give you a high-level understanding of the drug you wish to study in the treatment environment/care system. You can request a single report or a subscription, where a subscription report helps track changes in RWD and RWE over time.
Conducting Studies Using Real-World Evidence
Pharma companies can also sponsor investigator-initiated or collaborative research using healthie™. Study designs can be retrospective, prospective and/or ambispective, allowing for more specific and in-depth investigation into a disease area. Taking our Global Melanoma Registry Network as an example again, pharma companies have leveraged the existing RWD and expanded the study to include their own data for-side-by side comparisons with the registry data. Some companies have created new studies focused on patient reported outcomes that leverage the clinical data from the registry, and others are interested in expanding the registry to include different cohorts, such as adjuvant patients vs metastatic patients.
Sponsored longitudinal studies tend to run for longer terms, are more involved, and require the creation of a study protocol. Pulse Infoframe supports you for use cases such as safety, comparative efficacy and market access. To ensure you collect the information most clinically relevant to your research, clinicians specializing in your disease area of interest are often involved to help refine study questions and endpoints.
How Does the Process Work?
It’s fairly simple. Contact us to set up a call. The Pulse Infoframe team will ask you questions about the RWE you need, learn about your research goals, and collaborate with you to set up next steps.