Real World Evidence at RTI Health Solutions

While real-world evidence is nothing new, the landscape is evolving. What does that mean for you? 

The experts on our integrated project teams have been generating real-world evidence for decades, and they stay abreast of evolving methods and guidelines. You need to know where your research requirements fall under the broad umbrella of RWE. We help by designing and conducting the right study and staying with you throughout your product's lifecycle. The result? Evidence you need when you need it.

Our researchers have put together a few recommendations to help you navigate/understand the emerging ISPOR/ISPE Real World Evidence guidelines.

Guideline RTI Health Solutions Recommendations

1. Determine and declare that a study is either a Hypothesis Evaluation Treatment Effectiveness (HETE) study or an exploratory study 

  • Discuss intended end-user and plan for study appropriate to audience (e.g., clinicians, patients, regulators, payers). 

2. Post a HETE study protocol and analysis plan on a public study registration site prior to conducting the study analysis

  • Publish safety protocols

  • Publish effectiveness protocols where appropriate (such as research designed for regulatory review)

  • Date and sign all RWE study protocols and/or analysis plans before starting studies; consider sharing with journal editors/reviewers upon request

3. Publish HETE study results with attestation to conformance and/or deviation from the study protocol and original analysis plan. Possible publication sites include medical journals or publicly available websites

  • Reference location of published protocol within results (recommended when protocol previously published)

  • Encourage commentary on deviations from protocol within results, whether the protocol was previously published or not

4. Enable opportunities to replicate HETE studies so that other researchers can reproduce the same findings using the same data set and analytic approach

  • Utilize ISPOR/ISPE recommendations for reporting results in manuscripts

5. If feasible, perform HETE studies on a different data source and population than the one used to generate the hypotheses

  • If a different data source is not feasible, document the reason (e.g., due to population size or lack of other data sources)

6.  Work to publicly address methodological criticisms of the study once it is published

  • Encourage peer review and publication

  • Present work at international conferences (ISPOR, ISPE, disease-specific, etc.)

  • Ensure rigorous internal review processes including review by methodologic experts

7. Include key stakeholders (patients, caregivers, clinicians, clinical administrators, HTA/payers, regulators, manufacturers) in designing, conducting, and disseminating HETE studies

  • Consider engaging key stakeholders, including patients, within research teams

Learn how your drug development process can benefit from our teams - integrated across health economics, outcomes research, epidemiology, and statistics disciplines. Further, our highly respected industry experts can present your data to patient, clinical, regulatory, and reimbursement audiences. Let's talk about how this holistic approach can work for you.

Here's a look at some of our studies that have included real-world evidence, from our searchable publications database.

 

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