A committee of MEPs will soon vote on proposals that could increase transparency of clinical trials. However, there are 350 lobbyists for the pharmaceutical industry at the European Parliament and MEPs are now hearing their arguments against transparency every day. We have until 29th May to make sure they hear our arguments.
The Environment, Public Health and Food Safety Committee of the European Parliament, which is made up of 67 MEPs from 22 countries, is currently scrutinising the Clinical Trials Regulation. On Wednesday 29th May they will vote on changes to the regulation. There are proposals on the table that could greatly increase clinical trial transparency and would mean that all clinical trials for medicines licensed in Europe would have to be registered and the results reported.
Click here for Email addresses and sample letters to write to MEPs
On International Clinical Trials Day, the NIHR promotes its “OK to ask” campaign
International Clinical Trials Day is celebrated around the world on or near the 20 May each year, to commemorate the day that James Lind started his famous trial on the deadly disease scurvy. It provides a focal point to raise awareness of the importance of research to health care, and highlights how partnerships between patients and healthcare practitioners are vital to high-quality, relevant research.
On International Clinical Trials Day, the NIHR promotes its “OK to ask” campaign to encourage patients and the public to ask medical professionals about clinical research.
GSK gives update on plans to share detailed clinical trial data as part of its commitment to transparency
GlaxoSmithKline (GSK) new online system will enable researchers to request access to anonymised patient level data that sit behind the results of clinical trials. It is hoped that sharing these data with researchers will help to further scientific research, increase understanding of new and current medicines and ultimately improve patient care. Will other pharmaceutical companies follow?
During 2013/14 The National Institute for Health Research (NIHR) is promoting the fact that it’s OK to ask about clinical research. The campaign is aimed at patients, medical professionals and the public. Everyone can get involved and help spread the word that it’s OK to ask about clinical research. f you have a medical condition and are undergoing treatment, the NHS would like you to ask your family doctor, nurse or consultant about clinical research, and whether it might be right for you.
Why researchers MUST publish ALL results of clinical trials
” South Africans participating in clinical trials should demand that results are published ” says Cochrane Collaboration founder Sir Iain Chalmers. ” Much of the world’s clinical research was wasteful and failed to tackle issues that were most important to patients ” Sir Iain told delegates at a conference hosted by the Medical Research Council (MRC). ” Worse still, only 50% of the research was published, which meant doctors and patients were left in the dark about possible side effects, concealing evidence of potential possible harm from doctors and patients alike ” he said.
” … today consumers are angry at big business and demand more in terms of transparency and social responsibility … we have an industry that is leaking badly in consumer trust and every time they plug one leak another one pops open… ”
” It’s the Catch-22 of clinical trials: to protect pregnant women and children from the risks of untested drugs….we don’t test drugs adequately for them. In the last few decades, we’ve been more concerned about the harms of research than of inadequately tested treatments for everyone, in fact. But for “vulnerable populations,” like pregnant women and children, the default was to exclude them. And just in case any women might be, or might become, pregnant, it was often easier just to exclude us all from trials. “
The AllTrials transparency campaign says it is at a crossroads and is looking to take the next step into becoming a larger force against the restriction of clinical trial data by pharma. It continues: “There are many who hope that AllTrials will fizzle out and go away, as previous efforts have done – what happens next is up to all of us. We need your help to grow internationally, and to push for a decisive and permanent change.”
Around half of all clinical trials have not been published; some trials have not even been registered. If action is not taken urgently, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily.
A new campaignAll trials registered, all results reported – supported by the Medical Research Council (publicly funded organisation in the UK dedicated to improving human health) – calls for the results of all clinical trials to be made public. Sir Iain Chalmers, Coordinator of the James Lind Initiative, has strong words on researchers who hide trial results and ends his post by saying: “ If action is not taken urgently by research funders and regulators, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, unnecessary repetition of trials, and missed opportunities for good medical practice. ”