What Is Real World Evidence And Why Sponsors Need It

From Patient Stories to Policy Change

In traditional clinical trials, strict inclusion criteria, tightly controlled environments, and limited patient diversity are often necessary to prove efficacy. But what happens after approval, when therapies enter the real world where comorbidities, lifestyle factors, and variable adherence exist?

That’s where real-world evidence (RWE) comes in. And for sponsors working in emerging or alternative therapies, RWE isn’t just nice to have it’s essential.

Defining Real-World Evidence

Real-world evidence is the collection and analysis of health data gathered outside of randomised controlled trials (RCTs). This includes:

  • Observational studies

  • Patient-reported outcomes

  • Symptom trackers and treatment logs

  • Registries and feasibility studies

  • Health professional consult notes

RWE gives us insight into how therapies perform across actual patients, not just idealised trial populations.

Why It Matters for Sponsors

In emerging therapeutic spaces including medicinal cannabis, complementary therapies, and plant-based interventions traditional clinical trial pathways are often slow, expensive, and logistically difficult. Sponsors need earlier, richer insight to inform:

  • Product-market fit

  • Dosing strategies

  • Patient selection

  • Safety and tolerability in varied populations

  • Payer and policy engagement

RWE bridges this gap, offering evidence that is immediate, scalable, and grounded in day-to-day experience.

What TrueMed Offers

At TrueMed, we support sponsors with real-world data strategies that are ethically aligned, cost-efficient, and clinically valuable.

Our offerings include:

  • Feasibility protocol design

  • Customised patient and prescriber questionnaires

  • Telehealth consults for data collection

  • Symptom tracking tools with structured logging

  • Study summary reports and publication-ready insights

We help translate real experience into meaningful outputs white papers, briefing notes, and stakeholder-ready documentation.

RWE Builds Trust and Momentum

In an era where regulators, payers, and clinicians are demanding proof beyond the trial, real-world evidence is not optional. It’s foundational.

If you’re a sponsor developing or refining an alternative therapy, let’s talk about how TrueMed can build an evidence engine around your product, your patients, and your market.

Disclaimer

The information provided in this article is for educational purposes only and does not constitute medical advice. TrueMed does not sell or promote therapeutic products. Always consult a qualified healthcare professional before making decisions about your health or treatment options.

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