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 | ‘Summary statistics provided or extracted from the extra documentation were incorporated into meta-analysis’ |
| 2 | Unknown | Yes | CSRs | Yes | ‘Quantitative data about side effects were included’ |
| 3 | EMA, FDA | Yes | CSRs | No | ‘Data were not used in meta-analyses, but rather in a narrative form instead’ |
| 4 | EMA, FDA | Yes | EPARs and Medical Reviews | No | ‘Data was used to describe the number of studies and the number of studied drugs in results of search criteria’ |
| 5 | EMA, FDA, Multiple drug companies | Yes | FDA and EMA reports, Poster | Yes | ‘To add data on studies not aware of, and to add outcomes to a published study that were not itemised in the journal publication’ |
| 6 | Clinical investigator, EMA, sponsor | Noβ | No data were obtained | N/A | ‘Not provided by pharmaceutical sponsor, possibly because study stopped early due to unexpected side effects, and raw data may never have been compiled.’ |
| 7 | FDA, Health Canada, NIOSH | Yes | Adverse event reports | No | ‘The 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 studies’ |
| 8 | Clinical investigator, medical director of company | Yes | CSRs | Yes | ‘Assessed quality of the studies and extracted data for use in forest plots and description’ |
| 9 | Clinical Study Data Request, EMA, FDA | Other* | Case report forms | N/A | ‘N/A as data not received’ |
| 10 | Clinical investigator, EMA, Pharmaceutical company | Other¥ | Details of trial participants at start of trial (baseline data and info about randomisation) | No | ‘Only data at start of trial was available’ |
| 11 | EMA, GSK and FDA | Yes | Clinical and Statistical reviews at FDA, CSRs | Yes | ‘We checked the data for consistency (across multiple published and unpublished sources) and reported in the systematic review the most accurate and conservative estimates.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 confirmation’ |
| 12 | Pharmaceutical company | Yes | CSRs, IPD | Yes | ‘Data from CSRs & IPD were used in evidence synthesis’ ‘We know patient level data exists but we were not given access to it despite trying’ |
| 13 | Pfizer | Other* | CSRs | N/A€ | ‘Extraction of data from Pfizer Medical Information Report’ |
| 14 | EMA, FDA | Yes | CSRs, protocol with appendices | Yes | ‘We extracted, compared and used the aggregated effect estimates data for predefined outcomes’ |
| 15 | Helsinn, Merck and Pfizer | Yes | CSRs | Yes | ‘Where possible incorporated it as more likely to be the correct data than what was published’ |
| 16 | EMA, FDA | Yes | FDA medical and statistical reviews | Yes | ‘Performed data extraction from these sources. Compared with data from published sources’ |
| 17 | EMA, NIOSH | Yes | N/A | No | ‘Excluded studies’ |
| 18 | FDA | Yes | CSRs, FDA reports and IPD | Yes | ‘Data was used in place of publication’ |
| 19 | YODA | Yes | CSRs | Yes | ‘Data were used in network meta-analyses’ |
| 20 | Bristol-Myers Squibb, Genentech, Schering-Plough | Yes | CSRs | No | ‘In narrative synthesis. However, some of the data/text needed to be removed before the final technology assessment report is published under the confidentiality agreement’. |
N/A not applicable, FDA Food and Drug Administration, EMA European Medicine Agency, NIOSH The National Institute for Occupational Safety and Health
βResponse: ‘data not provided by pharmaceutical sponsor possibly because study was stopped early due to unexpected side effects and therefore the raw data may not have been complied’
*Still awaiting data/updating review
¥Intended data requested was not available
€Intend to incorporate data in a meta-analysis