Researchers call for streamlined safety reporting

by Anne Crawford

The Department of Anaesthesia and Perioperative Medicine at the Alfred and Monash University conducts large, independent Phase IV clinical trials to test the efficacy and safety of commonly used drugs. These ‘investigator-instigated’ or ‘public good’ trials are pragmatic, low-cost and carried out independently of drug companies.

As part of the trials, researchers report adverse events (AEs) and serious adverse events (SAEs). But the department’s researchers say ever-increasing and complex requirements from sponsors and ethics committees to report AEs and SAEs are duplicating reporting, thereby burdening researchers and causing a decrease in the uptake of research.


Department Director, Professor Paul Myles, and Ms Sophie Wallace, research manager in the department, are campaigning to streamline the reporting of AEs in Phase IV trials. They outlined their case recently in a paper published in the Medical Journal of Australia.

Ms Wallace said that investigator-initiated trials, funded by the NHMRC, test specific treatments, devices and practices to make sure that they are best practice.

“For example, some clinicians ask their patients to stop using aspirin before cardiac surgery because they think there’s a risk it increases cardiac bleeding; others don’t think this risk is a problem and are worried about other risks such as myocardial infarction. We addressed this practical and important question in our research,” she said.

The large, long-term ATACAS (Aspirin and Tranexamic Acid for Coronary Artery Surgery) study this year found that allowing patients to continue taking aspirin before undergoing coronary artery surgery did not have an impact on excessive bleeding or risk of death (excluding patients with a pre-existing bleeding disorder or other major risk factors for bleeding).

But having the researchers collect and disseminate safety data analysis took up time and resources, and was unnecessary, Ms Wallace said. “The burden of extra paperwork and reports is unnecessary and unhelpful,” she said.

“We’ve got an established data quality committee and safety committees that review these data in an unblinded and expert fashion. A lot of the time the AE reports to human research ethics committees (HRECs) serve no useful purpose as they get blinded data so they won’t know the treatment the patient received.

“Many people believe that while the safety to the patient is the most important thing, currently guidelines need to be changed or at least clarified.”

The NHMRC, which oversees the guidelines, is currently reviewing them, Ms Wallace said.

The paper’s authors recommend that safety information in Phase IV clinical trials be reviewed by the trial data safety and monitoring committee. This would enable safety data to be generated, analysed appropriately and a summary report provided to the trial steering committee, principal investigators and relevant ethics committees in a meaningful way, the paper said.

Wallace S, Myles PS, Zeps N, Zalcberg JR. Serious adverse event reporting in investigator-initiated clinical trials. Med J Aust. 2016 Apr 4;204(6):231-3.

MJA video of Prof Paul Myles and Ms Sophie Wallace: www.youtube.com/watch?v=hDdoyYz2V6Q&feature=youtu.be