Nordic Life Science 1
TOP STORIES BUSINESS ACQU I SITIONS // AGREEMENTS
// COLLABORATIONS NE W REP OR T M A NUF A C T UR I NG Hundreds of Nordic clinical trials remain unpublished A report jointly published by the AllTrials campaign, Cochrane Denmark, Cochrane Norway, Cochrane Sweden, the Dam Foundation, Melanomföreningen, and TranspariMED, shows that 475 clinical trials involving 83,903 patients completed during 2016-19 in Denmark, Iceland, Finland, Norway and Sweden, have never made their results public in any form. THIS ACCOUNTED FOR 22% of all clinical trial results across the five countries. In cases where clinical trial results were made public, there was often a delay in publication. Only 27% of all trials results were made public, in either registries or in journals, within 12 months, and within two years of study completion, only around half of the results were available to the public. Not only is this lack of transparency in clinical trials a waste of increasingly scarce public funding, it harms patients and leaves gaps in medical evidence, states the authors. Nordic countries have recently changed regulations that require institutions to make the results of drug and device trials public on registries within 12 months of completion. While clinical trials which ended in the years prior to 2023 are not included in this legislation, both the Declaration of Helsinki and WHO have clearly stated for years that the timely public sharing of results is an ethical obligation, stated Cochrane. “At Cochrane we highly value that findings of all studies become available. Otherwise, the B U S I NES S D E AL Key2Compliance acquired by GBA Group "WITH GBA GROUP, its structure and management, we found the right partner to foster our ongoing journey of growth and internationalization. The company’s culture of entrepreneurship, local autonomy, and genuine support, as well as the broad variety of revealing synergies between both companies’ services convinced me,” says Jan Hellqvist, CEO, Key2Compliance. Key2Compliance was founded in Stockholm, Sweden in 1994. Today the company employs more than 70 experts and, in addition to its headquarters in Stockholm, has two other branches in Sweden and one in Denmark. NLS synthesis of the evidence misses information thus resulting in misleading conclusions. This ultimately impacts the patients, clinicians and policy makers who need to make decisions based on a distorted picture of the evidence. This report should encourage initiatives to deal with this issue of medical research waste in the Nordic countries,” stated Matteo Bruschettini, Director of Cochrane Sweden. The report calls for policy makers in Denmark, Iceland, Finland, Norway and Sweden to adopt national legislation requiring that the results of all clinical trials are made public and to set up monitoring mechanisms. It also calls for national medicines regulators and research funders to put in structures to prevent research waste and ensure that clinical trial results are made public. This is in line with WHO recommendations which urged ethics committees, regulatory authorities, professional bodies, sponsors, investigators, and funding agencies to act in their jurisdictions to ensure results from all clinical trials are reported and publicly disclosed, Cochrane stated. NLS Anocca receives certificate of GMP compliance for in-house cell therapy facility This will become the largest facility in the Nordics for clinical supply of cell therapies, states Anocca. THE MANUFACTURING LICENSE paves the way for Anocca’s near-term path to the clinic and long-term strategy to advance franchises of precision targeted cell therapies for different cancers, covering diverse patient populations. “GMP certification of our in-house facility is a crucial milestone that allows us to confidently deploy the first of many TCR-T cell therapies into the clinic,” says Reagan Jarvis, cofounder and CEO, Anocca. NLS Reagan Jarvis, co-founder and CEO, Anocca 12 | NORDICLIFESCIENCE.ORG