Trials and errors

Imagine you are a university researcher interested in finding out if a new drug might be effective at preventing heart attacks. You secure public funding, secure ethics approval, and then start recruiting patients into your clinical trial. Half of patients get the new drug, and half of patients get a sugar pill that looks exactly the same. Two years in, the trial ends, and you crunch the numbers to see whether the new drug was effective.

Most trials don’t produce dramatic results, and sadly your trial is no exception. The patients receiving the new drug had just as many heart attacks between them as those receiving the sugar pill. At the same time, the patients receiving the new treatment experienced some unpleasant side effects. Clearly, it’s time to drop that line of research and move on – write a fresh grant proposal, and launch a new trial of a different, hopefully more effective drug.

What makes perfect sense to individual researchers is a disaster for medicine as a whole. If the results of your trial remain hidden, researchers elsewhere may run a similar trial again, wasting research funds and needlessly exposing more patients to side effects.

Worse, while the side effects detected during this one trial did not seem alarming at the time, scientists later discover that the drug you used is actually extremely dangerous. In retrospect, your trial data would have provided an early warning signal, but as they remained invisible, doctors continued to give the drug to millions of patients. This is exactly what happened with Lorcainide, a drug that that killed over 100,000 people over the course of a decade because the results of a single, small clinical trial remained hidden.

For these reasons, over 700 organisations, including the British Medical Association, have called for all clinical trial results to be made public.

In 2018, the science and technology committee of the House of Commons found that hundreds of clinical trials run by UK universities and NHS Trusts had not uploaded their results onto a European database designed to prevent research waste, in violation of European transparency rules. (Pharma companies typically perform far better at this.) Some institutions had not uploaded a single result. UK taxpayers were still paying for trials that failed to report their results and left dangerous evidence gaps in their wake.

In the wake of the committee’s enquiry, many universities and NHS Trusts began tackling their backlogs of unreported trials, leading to a steep increase in results uploaded to the European database. (Institutions, not individuals, are legally responsible for adding results to the database.) However, some institutions have still not uploaded a single result, and now that the dissolution of parliament has put an end to the enquiry, progress may grind to a halt.

Most public health problems are notoriously difficult – and expensive – to fix. Non-reporting of trial results is an exception to this rule. In the UK, every single clinical trial requires approval from an ethics committee before it begins, and all these approvals are already being centrally archived by the Health Research Authority (HRA) in London.

The HRA should use these records to check for each trial whether its results have been made public, and flag any unreported trials with the institution that ran them. If subsequent monitoring shows that the institution hosting the trial has still not gotten its act together, the HRA should bar it from hosting any more trials in the UK.

The feasibility of such a national monitoring system is beyond dispute; the HRA itself has already run a successful pilot. Cost estimates range from £250,000 to £2.4m per year, a drop in the ocean compared to the estimated 500 clinical trials costing £250m run by NHS Trusts alone that are currently in acute danger of becoming research waste. Nonetheless, it is unclear whether the current austerity-obsessed government will invest the pennies required today to save millions of pounds tomorrow.

The Labour party is aware of the problem. Its recent Medicines for the Many policy paper notes that “A systemic lack of transparency of clinical trial data has severe implications not only for the research process, but also for patient health… presenting risks to human health and increasing research duplication and wastage.” However, the document does not offer any solutions.

Every year, close to a million NHS patients volunteer their time to participate in clinical trials, many of them funded by public money. Patients and taxpayers alike deserve reassurance that their contributions will help to improve clinical practice and public health, rather than going to waste.

Labour should pledge to finally, once and for all, fix this problem by monitoring whether clinical trials conducted in the UK have made their results public, and by barring pharma companies, universities and NHS Trusts that break the rules from hosting any more trials.