Examining the Impact of Real-World Evidence on Medical Product Development Proceedings of a Workshop Series (2019) / Chapter Skim
Currently Skimming:
3 Learning from Success
3 Learning from Success
Pages 25-38
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 25... ...
• Sentinel, a U.S. Food and Drug Administration medical prod uct monitoring system that uses electronic health data to sup port postmarketing medical product evaluation, is a distributed system that allows data partners to retain private data prior to data curation; Sentinel allows for datasets to be studied using different methods, but still systematically evaluated under known conditions.
|
From page 26... ...
(Fleurence) • Registries are already used widely in the device space, and increased use of RWD and RWE for devices could push regis tries toward Coordinated Registries Networksa that link exist ing registries to other existing data sources such as claims data and EHR data.
|
From page 27... ...
Northwest EHealth, which was established in 2008 to improve research using EHRs, had already worked in the community and there was a "connected community of care." Gibson stressed that this element was critical to the success of the Salford studies. Gibson gave a brief overview of the design of the COPD study (see Figure 3-1)
|
From page 28... ...
and/or LAMA • Exacerbation in last 3 years Usual care • Consented During the 12 month treatment period, patients can have their maintenance treatment adjusted (stepping up, stepping-down or switch) in both arms, at the GP's/Investigator's discretion as would be normal clinical practice FIGURE 3-1 Salford Lung Studies design.
|
From page 29... ...
One benefit of monitoring patients in near real time, said Kane, was that serious adverse events could be detected and reported almost immediately. The safety monitoring system was set up with criteria for alerting researchers about potential safety issues, and a safety team reviewed these alerts on a daily basis.
|
From page 30... ...
; NWEH = Northwest EHealth; PAS = patient administration system; SLS = Salford Lung Studies; SUS = Secondary Uses Service. SOURCE: Gibson and Kane presentation, September 19, 2017.
|
From page 31... ...
Other tools that Northwest EHealth has developed, said Gibson, include tools for recruiting and engaging patients. The system for recruitment allows researchers to screen the population and identify patients who may be appropriate subjects (using anonymized information)
|
From page 32... ...
Food and Drug Administration (FDA) in response to legislation that required FDA to use electronic health data to support postmarketing medical product evaluation, said Richard Platt, professor and chair, Harvard Medical School, and executive director, Harvard Pilgrim Health Care Institute.
|
From page 33... ...
FIGURE 3-3 Data elements available in Sentinel. NOTE: ID = identification.
|
From page 34... ...
Platt noted that this observational study correlated well with randomized trials, which "should give us some confidence that we can be attentive to how the product is working in actual practice." Furthermore, using Sentinel data allows researchers to explore populations that are not well represented in the clinical trial. Platt noted that "others may not agree" with using observational data in this way, but that for situations or populations where a clinical trial will not be done, there may be ways "to decide whether the observational data are credible enough." Sentinel with Chart Review: Risk of Intussusception After Rotavirus Vaccination (Yih et al., 2014)
|
From page 35... ...
Sentinel data partners have data about linked mother–infant pairs, unlinked mothers, and unlinked infants, and state departments of health have birth certificate data. Researchers attempted to link moms and infants using these data, and were able to link more than 80 percent of the records from four data partners.
|
From page 36... ...
This trial is an example of using available data to enable pragmatic research, and demonstrates how Sentinel could similarly be used. Sentinel Linked with Patient-Reported Data: A Mobile App for Studies of Medication Safety4 Sentinel researchers built a mobile app to enable individuals who have data in the Sentinel system to report information that can easily be merged with the system, said Platt.
|
From page 37... ...
Approval requires disclosure of adverse events, and manufacturers must conduct postapproval safety studies. The National Drug Code ensures that the drugs that patients take can be accurately identified in claims and EHR data.
|
From page 38... ...
Fleurence noted in particular that there are challenges with administrative issues -- for example, the length of time it takes for research studies to obtain legal review and Institutional Review Board approval. She hypothesized that the single device registries model is likely to evolve soon.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.