Table 2 Description of data obtained and how they were used in the systematic reviews
Survey reply | Source of data request(s) | Data obtained | Type of regulatory data/document(s) obtained | Included in meta-analysis | Description of how data were used |
|---|---|---|---|---|---|
1 | Author, manufacturer | Yes | CSRs | Yes | āSummary statistics provided or extracted from the extra documentation were incorporated into meta-analysisā |
2 | Unknown | Yes | CSRs | Yes | āQuantitative data about side effects were includedā |
3 | EMA, FDA | Yes | CSRs | No | āData were not used in meta-analyses, but rather in a narrative form insteadā |
4 | EMA, FDA | Yes | EPARs and Medical Reviews | No | āData was used to describe the number of studies and the number of studied drugs in results of search criteriaā |
5 | EMA, FDA, Multiple drug companies | Yes | FDA and EMA reports, Poster | Yes | āTo add data on studies not aware of, and to add outcomes to a published study that were not itemised in the journal publicationā |
6 | Clinical investigator, EMA, sponsor | NoĪ² | No data were obtained | N/A | āNot provided by pharmaceutical sponsor, possibly because study stopped early due to unexpected side effects, and raw data may never have been compiled.ā |
7 | FDA, Health Canada, NIOSH | Yes | Adverse event reports | No | āThe data did not provide some of the detail we would have liked, such as indication for the drug, dosing etc. We summarized the results in narrative form but did not include in the quantitative analyses of the data we retrieved from published studiesā |
8 | Clinical investigator, medical director of company | Yes | CSRs | Yes | āAssessed quality of the studies and extracted data for use in forest plots and descriptionā |
9 | Clinical Study Data Request, EMA, FDA | Other* | Case report forms | N/A | āN/A as data not receivedā |
10 | Clinical investigator, EMA, Pharmaceutical company | OtherĀ„ | Details of trial participants at start of trial (baseline data and info about randomisation) | No | āOnly data at start of trial was availableā |
11 | EMA, GSK and FDA | Yes | Clinical and Statistical reviews at FDA, CSRs | Yes | āWe checked the data for consistency (across multiple published and unpublished sources) and reported in the systematic review the most accurate and conservative estimates. If needed, we contacted authors for confirmationā |
12 | Pharmaceutical company | Yes | CSRs, IPD | Yes | āData from CSRs & IPD were used in evidence synthesisā āWe know patient level data exists but we were not given access to it despite tryingā |
13 | Pfizer | Other* | CSRs | N/Aā¬ | āExtraction of data from Pfizer Medical Information Reportā |
14 | EMA, FDA | Yes | CSRs, protocol with appendices | Yes | āWe extracted, compared and used the aggregated effect estimates data for predefined outcomesā |
15 | Helsinn, Merck and Pfizer | Yes | CSRs | Yes | āWhere possible incorporated it as more likely to be the correct data than what was publishedā |
16 | EMA, FDA | Yes | FDA medical and statistical reviews | Yes | āPerformed data extraction from these sources. Compared with data from published sourcesā |
17 | EMA, NIOSH | Yes | N/A | No | āExcluded studiesā |
18 | FDA | Yes | CSRs, FDA reports and IPD | Yes | āData was used in place of publicationā |
19 | YODA | Yes | CSRs | Yes | āData were used in network meta-analysesā |
20 | Bristol-Myers Squibb, Genentech, Schering-Plough | Yes | CSRs | No | āIn narrative synthesis. However, some of the data/text needed to be removed before the final technology assessment report is published under the confidentiality agreementā. |