Real World Evidence (RWE)Generation: Governance and Game Plan

In today's fast-paced healthcare landscape, pharmaceutical companies are under immense pressure to demonstrate the real-world effectiveness and safety of their products. Traditional clinical trials, while essential, often fail to capture the nuances of how patients respond to treatments in their day-to-day lives. Enter real world evidence (RWE) – a game-changer that promises to revolutionize the way we understand and market healthcare interventions.

RWE offers a unique window into the lived experiences of patients, uncovering insights that can inform everything from product development to targeted marketing campaigns. By harnessing the power of real-world data sources, such as electronic health records, patient-reported outcomes, and claims data, pharmaceutical companies can unlock a wealth of actionable intelligence that was previously out of reach.

Real world evidence (RWE) is data collected from real-world settings, such as electronic health records (EHRs), patient-reported outcomes (PROs), and claims data. RWE can be used to study the effectiveness and safety of drugs and other medical interventions in the real world. There are a number of challenges to generating RWE in lower middle-income countries (LMICs) like India.

These challenges include:

·???Lack of data infrastructure. Many LMICs do not have well-developed electronic health records systems, which makes it difficult to collect and store RWE.

·???Data quality. Even when data is available, it may be of poor quality due to factors such as incomplete records, inaccurate coding, and missing data.

·???Cultural and linguistic barriers. RWE studies need to be designed in a way that is culturally and linguistically appropriate for the target population.

·???Lack of resources. Conducting RWE studies in LMICs can be expensive, and there may be limited resources available to support these studies.

Despite these challenges, there are a number of opportunities to generate RWE in LMICs. These opportunities include:

·??????? The use of mobile health (mHealth) technologies. mHealth technologies can be used to collect RWE in a cost-effective and efficient manner.        

·??????? The use of patient-reported outcomes (PROs). PROs can be used to collect data on patient experiences and outcomes, which can be valuable for RWE studies.        

The generation of RWE in LMICs is an important step towards improving the quality of healthcare in these countries. By overcoming the challenges and capitalizing on the opportunities, LMICs can generate RWE that can be used to make better decisions about the use of medical interventions.

Here are some additional challenges of executing RWE studies in LMICs:

·??????? Lack of regulatory support. In some LMICs, there may be limited regulatory support for RWE studies. This can make it difficult to obtain the necessary approvals and permissions to conduct these studies.        

·??????? Lack of awareness. There may be limited awareness of RWE among healthcare professionals and policy makers in LMICs. This can make it difficult to promote the use of RWE in decision-making.        

·??????? Lack of funding. There may be limited funding available to support RWE studies in LMICs. This can make it difficult to conduct these studies, especially large-scale studies.        

Using smartphones and social apps like Whats App are very common in our daily life and quite likely the and easiest option would probably to use them for RWE. However, the challenge is compliance guidelines like HIPPA, PHI and 21CFR. As a mandatory you need to have BAA (Business Associate Agreement) in place to use any platform for data collection.

Health Data must be protected throughout the entire journey, -on the device, -during transit, -on the server, -auditable, -verified users.

The 18 PHI Indicators are a set of identifiers that are used to help determine whether a piece of information is considered PHI and, therefore, subject to the protections required under HIPAA.

Before you decide on embarking Real Word Evidence Generation, you need to clearly?? - Define the scope of the study, - Identify the target population and the data required, - Establish the study objectives and key performance indicators (KPIs), - Develop a project plan with timelines.

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1.????? ?Data Collection:

-??????? Use WhatsApp Business API to facilitate communication between the patients and the Pharma company.

-??????? Develop a chatbot to interact with patients, collect responses, and provide information.

-??????? Integrate E-Signature feature to authenticate the identity of the patient before data collection.

-??????? Ensure the chatbot asks for consent before collecting any data.

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2.????? Data Capture:

-??????? Use WhatsApp's end-to-end encryption feature to ensure data privacy.

-??????? Store the data in a secure, encrypted database.

-??????? Use data validation techniques to ensure the accuracy and consistency of the data.

-??????? Implement a system check to ensure HIPAA compliance, as well as compliance with PCI, GDPR, CCPA, and SOC 2.

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3.????? Data Analysis:

-??????? Use data analytics tools to analyze the collected data.

-??????? Generate reports and visualizations to present the findings.

-??????? Use the results to make informed decisions and improve the effectiveness of the study.

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4.????? Data Security:

-??????? Implement robust data security measures to protect sensitive patient information.

-??????? Conduct regular audits to ensure compliance with HIPAA, PCI, GDPR, CCPA, and SOC 2.

-??????? Provide training to staff on data privacy and security practices.

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5.????? Project Closure:

-??????? Evaluate the project against the defined objectives and KPIs.

-??????? Document the lessons learned and best practices for future studies.

-??????? Archive the data securely in compliance with data retention policies.

This workflow ensures that the study is conducted in a systematic, secure, and compliant manner, with each data entry validated and authenticated by the patient. It also ensures that the data is analyzed effectively to generate meaningful insights for the Pharma company.

The potential of RWE to transform healthcare marketing is truly staggering. By embracing this data-driven approach, pharmaceutical companies can forge deeper connections with their target audiences, crafting messaging and campaigns that resonate on a profound level. However, generating and leveraging RWE is no small feat, requiring a delicate balance of technical expertise, regulatory compliance, and strategic vision.

If you're ready to unlock the full potential of RWE and gain a competitive edge in the ever-evolving healthcare landscape, now is the time to reach out and explore how my team of experts can guide you on this transformative journey. Together, we can redefine the art of healthcare marketing, elevating patient experiences and driving meaningful impact at every turn.

The future of healthcare marketing is here, and it's fueled by the rich insights of real world evidence. Embrace this opportunity, and let us help you navigate the challenges and seize the boundless possibilities that lie ahead.