At the end of June, the city of Pamplona was getting ready to celebrate the fiestas in honour of San Fermín, the patron saint of Navarra, and the week long challenge of the encierro (running of the bulls). Much ceremony and excitement surrounds this relatively short run of 825m, which typically lasts four minutes as the bulls charge from the corral in Calle Santo Domingo to the bullring. The risks to human participants are well known and each year, of the 20 000 people who take part, 200-300 are injured (1-1.5%), and there have been 16 deaths since 1910 (0.15 deaths/year). The benefits of participating are harder to determine, but would probably be best described using a composite endpoint of relief, satisfaction, and elation. Those who want to make an informed decision on taking part can easily find statistics on the harms, and view television recordings of the event to see what happens to those who do run with the bulls.
The challenge of accessing comprehensive and usable information on the harms and benefits of drug treatment was a theme running through the triennial ISDB General Assembly. In the safety of an ornate building beside Pamplona’s 15th century cathedral, editorial teams from independent drug bulletins from around the world met.
The aim of such bulletins is to improve the quality of healthcare by providing relevant, reliable, comparative, and independent information about treatments that promotes more rational and informed decisions about their use. ISDB was formed in 1986 with the recognition that drug bulletins that are intellectually and financially independent from the pharmaceutical and medical device industry experience problems not faced by editors and publishers of other journals. ISDB supports bulletin producers to achieve the highest professional standards, and encourages and assists in the development of independent bulletins across the world.
Drug and Therapeutics Bulletin (DTB), a founder member of ISDB, along with colleagues from other parts of Europe, North and South America, Asia, and Australia met to share good practice and discuss some of the key challenges facing those who produce independent drug bulletins.
Many drug bulletins review newly licensed medicines, and draw on information about a drug’s efficacy and safety from clinical trials published in peer reviewed journals, regulatory summary documents, and safety reports. DTB largely uses source material that is published and in the public domain so that the basis for the conclusions is available for independent assessment. However, an update from Tom Jefferson (Cochrane Collaboration, Italy) on the work of the “Restoring Invisible and Abandoned Trials” project provided a timely reminder of the challenge facing those trying to make sense of data at the tip of the “information iceberg.”
The problem of reporting bias relating to unpublished and unregistered trials is well known and has been subject to much debate. However, as drug regulatory organisations change policies and more data become available, more of the iceberg becomes visible. In particular, researchers are now beginning to access full clinical study reports (CSRs) from clinical trials. Although CSRs run to many hundreds of pages, they are usually published in a peer reviewed journal as an article of five to 10 pages, which is summarised as an abstract of 300 words with a conclusion (the only bit many people read) of 30 words. Trying to distil the complexity of a multinational, multicentre clinical trial in this way seems rather like trying to capture the bible in a tweet—how much vital information is left out and what nuances are missed when information is compressed in this way?
The move to release more data is welcome, but it is important to recognise that it will present new challenges in data handling, processing, analysing, and interpretation. New skills, expertise, and capacity will be needed by those whose job it is to make sense of such data to ensure that clinicians are presented with more light than noise. Releasing an ever greater volume of data from the corral of clinical research will require a fleet footed response by bulletin producers. Let’s hope nobody gets hurt in the process.
David Phizackerley has been working to promote the rational use of medicines for over 25 years. For many years, he worked closely with healthcare professionals in primary care to develop educational and practical initiatives to support evidence based, cost effective prescribing. Since 2009, he has been the deputy editor of Drug and Therapeutics Bulletin.
Competing interests: See DTB‘s website.
This blog is part of a series of blogs linked with BMJ Clinical Evidence, a database of systematic overviews of the best available evidence on the effectiveness of commonly used interventions.