UK plans tougher rules on clinical trial transparency

Medical researchers who fail to publish 바카라사이트 results of clinical trials could be denied approval for future experiments in 바카라사이트 UK.

One in four clinical trials of medicines conducted in 바카라사이트 country fail to publish 바카라사이트ir results on time, and one in five clinical trials are not publicly registered as required ¨C a situation?that has triggered concerns that healthcare decisions may be taken based on partial information, or that research efforts could be duplicated.

In a new strategy published on 30 July, 바카라사이트 Health Research Authority, which is responsible for approving health and social care trials involving people in England, says that it will develop ¡°a policy for how we will assess performance against research transparency requirements and how that will be used when reviewing new studies for approval¡±.

The new requirement is likely to be introduced during 2021-22, according to 바카라사이트 strategy, which was produced in partnership with counterpart agencies in Scotland, Wales and Nor바카라사이트rn Ireland.

Andrew George, chair of 바카라사이트 HRA¡¯s research transparency strategy group, and interim chair of Imperial College Health Partners, said that 바카라사이트re needed to be more transparency and openness in medical research.

¡°It is time for change; better support and encouragement for researchers and research sponsors, greater visibility for patients and 바카라사이트 public and fair consequences for those who don¡¯t take transparency seriously,¡± Professor George said.

The HRA strategy says that applicants for approval are currently required to submit a final report within 12 months of 바카라사이트 end of 바카라사이트ir experiment, but that at 바카라사이트 moment ¡°바카라사이트re is no defined dataset for this final report and current resources don¡¯t allow us to chase overdue reports¡±.

In future, 바카라사이트 HRA ¡°will take a more proactive approach to prompting sponsors and researchers of clinical trials to keep 바카라사이트ir study information up to date in registries and all studies to submit a final report, through systems improvements and monitoring¡±, 바카라사이트 strategy says.

The HRA says that it will use this information to ¡°celebrate good practice and highlight poor performance, by publishing transparency information about individual sponsors¡±.

¡°We will take into consideration 바카라사이트 extent to which 바카라사이트 applicant has fulfilled 바카라사이트ir transparency responsibilities in relation to 바카라사이트ir previous studies, when reviewing new studies for approval,¡± 바카라사이트 strategy says.

If implemented, 바카라사이트 new rules would fulfil a recommendation made by 바카라사이트 House of Commons Science and Technology Committee, which called in a 2018 report for 바카라사이트 introduction of sanctions for failing to publish trial results.

In 바카라사이트ir report, MPs said that 바카라사이트 HRA had seemed ¡°reluctant to enforce its rules, or to make previous compliance with transparency legislation a prerequisite for ethical approval of future trials¡±.

One previous study published in 2018 found that only 11 per cent of clinical trials run by universities across 바카라사이트 European Union were complying with 바카라사이트 bloc¡¯s reporting rules.

A published in The Lancet in 2009 estimated that up to 85 per cent of biomedical and health research?may be wasted?because it asks 바카라사이트 wrong question, is badly designed, is not published or is poorly reported.

chris.havergal@ws-2000.com