Real-world data (RWD) studies have been increasingly conducted in support of regulatory approvals and changes in clinical practice for novel oncology drugs, but a retrospective cohort study has found that many of these studies lack in quality.

The study is the first systematic evaluation of RWD studies reporting the effectiveness of cancer drugs approved between 2010 and 2015 for treating solid organ malignancies in the noncurative setting, according to the researchers. Published in the European Journal of Cancer, the study analysis was confined to antineoplastic and immunomodulating agents for solid tumors in the noncurative setting, the UK, Canadian and New Zealand researchers noted.

Using the Newcastle Ottawa Scale, they scored 293 RWD studies of drugs approved by the FDA and European Medicines Agency (EMA) between 2010 and 2015. The researchers found that most were of poor methodologic quality. Specifically, 230 (78 percent) of the studies were low quality, scoring zero to 3 on the scale, while just 63 (22 percent) were of moderate quality, meaning they had a score of 4 to 6. Notably, none were found to rank in the 7 to 9 range, the scale’s bracket for high quality.

The researchers also assessed study quality compared to funding status. Those studies that were funded saw a trend toward higher quality compared to those that didn’t receive funding, although the trend wasn’t statistically significant. But for pharma industry funded studies, a statistically significant difference was seen, with 35 percent of those studies meeting the criteria for medium quality compared to just 17 percent of those that didn’t receive industry funding.

The survival outcomes for RWD studies were usually worse than their pivotal trials, the researchers also found. Conducting a survival analysis of the RWD studies, they found that a little more than one-third (37 percent) of the RWD studies had superior survival outcomes; the survival outcomes for the rest (63 percent) were inferior.

In addition, the RWD studies were found to have a number of limitations, mainly in patient selection and assessment/control of confounders and in the evaluation of the studies’ endpoints. Of the 293 studies, only five did a comparative assessment of the intervention drug with the comparator drug used in the pivotal trial, the researchers determined.

“We find that most new FDA and EMA approved drugs for solid organ cancers have RWD studies; however, the overall quality is very low and would presently be of insufficient rigor to support regulatory approvals and reimbursement,” the researchers said. “We also find that the majority of RWD studies report survival outcomes that are inferior to randomized controlled trials, suggesting that the benefits observed in trials are not translated into the real world. Of concern is that low-quality studies are more likely to overstate the benefits of new cancer drugs.”

In conclusion, the researchers said that the standards for RWD studies of cancer drugs needs to improve in quality and consistency before they are used routinely to support clinical practice and policy changes.

Read the full study here: https://bit.ly/3g0w4BQ.