While real world evidence is nothing new, the ways it is being used are. 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.
Below, 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 |
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1. Determine and declare that a study is either a Hypothesis Evaluation Treatment Effectiveness (HETE) study or an exploratory study |
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2. Post a HETE study protocol and analysis plan on a public study registration site prior to conducting the study analysis |
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3. Publish HETE study results with atestation to conformance and/or deviation from the study protocol and original analysis plan. Possible publication sites include medical journals or publicly available web-sites |
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4. Enable opportunities to replicate HETE studies so that other researchers can reproduce the same findings using the same data set and analytic approach |
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5. If feasible, perform HETE studies on a different data source and population than the one used to generate the hypotheses |
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6. Work to publicly address methodological criticisms of the study once it is published |
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7. Include key stakeholders (patients, caregivers, clinicians, clinical administrators, HTA/payers, regulators, manufacturers) in designing, conducting, and disseminating HETE studies |
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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.