This week, Clinical Trials Arena will be shining a spotlight on real world data as part of March’s ‘Transparency Week’. Running throughout the week of March 27, 2017, CTA will post articles uncovering the most pressing issues facing industry today.
Experts, such as, Dr Sarah Markham, shine a spotlight on the AllTrials campaign, an initiative started in 2013 that seeks have all clinical trials registered into one database. Meanwhile, CTA regular Deborah Collyar (PAIR) explains why sharing results are good for patients and the research community.
But first, be sure to visit CTA tomorrow when Christopher Hart, Director of Information Practice, draws attention to an initiative that could change the way trials are reported and accessed.
In the meantime, catch up on some CTA’s most recent stories delving into the challenges of clinical trial transparency... (click on the headline to finish reading)
For more than two decades, transparency has been an aspirational goal of the European Medicines Agency (EMA). The EU-regulation (536/2014) that has been effective since 2015, took transparency one step further. It mandates that all sponsors of clinical studies need to make the study results available, not only as a scientific summary but also as a summary “that is understandable for laypersons”. The plan is that the clinical study report, the scientific summary and the layperson summary are posted on the same location on the EU-portal. Thus, for the very first time, everybody will have access to the results of any clinical study in Europe. The web infrastructure, i.e., the EU-portal, is currently being developed and is likely to “go live” in autumn 2018.
One longstanding issue that has dogged the pharmaceutical industry for decades has been its chequered history in publishing clinical trial (CT) results. For decades now, trial disclosures for new drugs have fallen well short of legal and ethical standards (BMJ Open). Analysts argue that without fully disclosing the results of CTs, the ability of healthcare decision-makers (physicians, prescription guideline writers, et al.) to evaluate the appropriate use of a drug is impaired (DD&D). But more importantly, it's the inaccessible nature of CT results that puts the health and safety of the patient most at risk.
As the dust settles on the tragedy that occurred in France where one patient died in a Phase 1 clinical trial, the details over how it happened are yet to be revealed. Naturally, questions have been asked and initial responses from the industry have been mixed. Some experts have been quick to lament what was "a terrible outcome," while admitting it's too soon to know if errors were made or if it was just "a horrible accident."
Conversely, others are questioning how such a tragedy could happen, given all we know and are learning about genetics and genomics. But ultimately, most are concerned over whether all the measures were carried out to ensure the safety of the patient.
PHOTO CREDIT: Honest Reporting