Every time we want to know if a new drug discovered in labs is effective, we conduct a “simple” Randomized Controlled Trial (RCT), a fascinatingly basic experiment known to humans since biblical time.
RCTs are a very potent tools to help patients, doctors and regulatory bodies to understand the efficacy of any medical intervention, and most importantly, its limitations.
So far, so good. Now, there is one, simple problem with all this: not all RCT are publicly available. Best guesses indicates that 50% of RCTs have never seen the light. This means that we don’t know the results of half of the attempts made to understand the efficacy of a new medical procedure. If this doesn’t sound tragic enough to you, take this: if I flip a coin and hide from you half of the results I get from it, I can convince you that I have a tricked coin, or a miracle one that gives you head all the time. Like a magic pill.
We need to have access to all data, all trials and all details. There are scientists out there that spend a great deal of time making summaries of all RCTs, to get a better pictures on whether a specific treatment works or not (I discussed this already in this blog). If their summaries are based on only SOME of the literature, what’s the hope we get an unbias pictures of risks/benefits of treatments? We need to take action.
A global call for more transparent clinical trials from both academia and industry-funded research has pushed the European Medicines Agency (EMA – pharmacological regulatory body in EU) to compile a new draft policy on the publication and access to data they have, but currently no one else could see.
EMA itself confesses that the new draft is the best compromise they could do to balance out the commitment to give widest possible access to data for independent scrutiny with the need to protect personal data as well as legitimate commercially confidential information.
If by now you got very much lost on all this, I do recommend this brief reading.
Nicely, EMA has opened the new policy draft to a public consultation. Here’s the copy of my letter to them, which will also be published entirely on EMA webpage together with all the other public reply at the end of the consultation (due to Sept 30th):
With reference to the Declaration of Helsinki, I don’t see why every investigator running a clinical trial should not register it before its beginning and report about the results, fully, in due time after the trial ends. The ethical motivation are obvious: millions of volunteers that participated in clinical trials did that because they thought that were collaborating to find out more about the effects of treatments on disease, to help other patients and medical doctor informed decision.
Unfortunately, this obvious ethical principle about reporting has been widely ignored. Withhold of valuable information from some of the clinical trials are damaging patients, as prevent clinicians from having clear figures on efficacy and side effects of a drug or any other medical intervention.
These motivaitons have led me to fully support the AllTrials campaign, which is now supported by other 57,700 people and over 400 organisations worldwide, including research funders, regulatory bodies, consumer organisations, medical Royal Colleges, professional and learned societies, journals, pharmaceutical company GSK and more than 200 patient groups.
- I encourage the European Medicines Agency to ensure a full access to clinical trial informations that the Agency already holds. I believe that if data is submitted to support a marketing authorisation for a medical product in Europe then this data should be available for scrutiny by researchers. More then one eye will help having safer medical products.
- I agree that the EMA has a role to play in the dissemination of this data. I welcome the EMA’s proposal to proactively publish clinical study reports from clinical trials submitted in support of a marketing authorisation application. Clinical study reports contain a large amount of detailed information about the methods, analysis, results and conclusions of clinical trials. These information is needed to make and to scrutinise decisions about medicines and to assess published summary findings – with special reference to collaborations specifically designed for Meta-Analysis studies.
- Individual patient data should be available on request to researchers with a commitment that no reasonable request will be refused.
- I support the EMA’s policy that (in general) the data included in clinical trial study reports should not be considered commercially confidential once a marketing authorisation has been granted. Why should pharmaceuicical indutry withhold such information is a mistery to me. I fail to see their point. On the other hand, it will have huge benefits for patients, health workers, doctors, pharmacists, regulators and researchers. It will benefit treatment decisions now and research into future options. I wish the EMA to implement its new policy as soon as possible.
Yours truly, Riccardo Guidi – PhD student Karolinska Institutet, Sweden
PS: this letter takes A LOT of material form the original letter that AllTrials, a campaign designed by BadScience, born in January 2013 that pushes for a more transparent medical regulation process.
Full letter form AllTrials to EMA can be found here.