New UK Life Sciences Strategy: more trials, more research waste?
The UK government's recently released Life Sciences Industrial Strategy talks a lot about conducting more clinical trials - but it says nothing about generating more trial results.
This focus on the volume of trials, rather than the volume of trial ressults, means that Britain's contribution to the $85 billion in medical research waste generated annually by clinical trials that fail to report their outcomes could grow even further in future years.
The strategy sets out the following strategic goal:
"To support a 50% increase in the number of clinical trials over the next 5 years and a growing proportion of change of practice and trials with novel methodology over the next 5 years."
However, how many of these expensive trials will actually benefit UK patients and contribute to furthering medical knowledge? Trials can only benefit patients and science if they report their results.
Too often, the outcomes of trials conducted in the UK are reported only with great time delays, incompletely or not at all. TranspariMED's recent study of trials sponsored by British universities indicated that much of the clinical research they conduct ends up being partially or completely wasted.
The Life Sciences Strategy is also overly fixated on revamping regulation to speed up trial approval, but says nothing about improving regulation to speed up the sharing of trial outcomes, even though this is a persistent problem that significantly slows down medical innovation and would be cheap and easy to address.
Important update (06 December 2017) The new Life Sciences Sector Deal published as part of the Industrial Strategy annoounces that the Health Research Authority will integrate, optimise and automate approval processes in order to speed up ethics approvals . This presents a unique opportunity to redesign the approval system so that national clinical trial audits can be performed routinely and semi-automatically.
Below key passages from the government's strategy and TranspariMED's comments.
"[T]he creation of clinical trial networks by the NIHR has greatly enhanced the functional capability to deliver large-scale trials quickly and efficiently, enabling a considerable increase in trial activity in the NHS over the past ten years."
Comment: Activity does not equal outcomes. Increasing activity is very expensive, ensuring that outcomes of those activities get reported is not.
"Although efforts have been made to streamline ethical approval for clinical trials through the creation of the Health Research Authority (HRA), this office still does not operate with the efficiency that is necessary. Steps are in place to improve the delivery of national ethics approval and to reduce bureaucracy and red tape in this arena. A small additional investment would greatly advance this activity."
Comment: A small investment is also all that is needed to enable the HRA, which is currently under-funded, to monitor trial registration and results posting. There is no point in speeding up trial approval times by a week if those same trials then take years to report results - sometimes in violation of existing regulations that the HRA is currently unable to enforce.
"The UK should work with industry and regulators to establish a working group to evaluate the
use of digital health care data and health systems to evaluate the safety and efficacy of new
Comment: As Cochrane, AllTrials and others have long and convincingly argued, we need to be able to see the full results of all trials to reliably evaluate the safety and efficacy of new interventions. Right now, scientists can only see part of the evidence on new treatments, and unless the government takes action, that will not change.
"[T]he implementation of digital tools to provide the environment for paperless trials will all greatly enhance the quality of information obtained by commercial partners when operating in the NHS and will greatly speed up both the recruitment and the implementation of clinical trials, including the use of electronic data capture and informed consent, thus significantly reducing cost.
Comment: Yes, but what about the quality of information obtained by patients, doctors, NICE and the wider scientific community? Paperless trials potentially offer a great opportunity for enhanced disclosure and more transparency of methods and results - but the strategy does not mention this.
"UK patients and clinicians would benefit from innovative product use in the clinical trial setting knowing that, should the value be proven, the medicine would rapidly become more widely available, helping drive the spread of these innovations at pace and scale."
Comment: At present, it is difficult to conclusively "prove" the value of any new drug, device or treatment because many trials do not report results, and the evidence from other trials is partial at best and systematically distorted at worst.