Written Evidence Submitted by Universities Allied for Essential Medicines UK

(RRE0036)

1. Summary
    

• Universities Allied for Essential Medicines UK is a campus-based access to medicines organisation whose activities include conducting meta-research on research ethics and integrity.
• We believe that UK universities have a particular responsibility to demonstrate best practice in the reporting of trial results because they are usually publicly-funded, and inadequate reporting leads to research waste, which has a demonstrable impact on UK patients, taxpayers, and investors.
• We have recently published a report that highlights this issue in thirty UK universities, finding that 89.8% of trials sponsored by these universities remained unreported on the international trials database ClinicalTrials.Gov.
• We argue that to effectively change trial reporting practices to mitigate the impacts of inadequate and untimely reporting, the Health Research Authority should enforce increased sanctions against non-compliant sponsors as soon as reasonably possible.

2. UAEM UK 

Universities Allied for Essential Medicines (UAEM) UK is a local branch of a broader student-led access to medicines advocacy organisation, which is based across three continents. Among other advocacy activities, a large part of UAEM action across the globe is directed towards improving the quality and transparency of research practices. One particular issue that UAEM UK have focussed on, in partnership with other organisations, has been the untimely and inadequate reporting of clinical trial results. This has significant and dangerous implications for patients and UAEM UK have previously submitted evidence to an inquiry outlining these impacts. In collaboration with TranspariMED, we first conducted an assessment of UK universities’ clinical trial transparency practices and policies in 2018, and have provided regular updates since. In light of this, we argue that while the sanctions recently proposed by the Health Research Authority (HRA) are a welcome step forward, we must introduce them as soon as possible to ensure that results of trials conducted at universities are reported within one year. 
 

3. The problem

The consequences of incomplete and inaccurate reporting of trial results is a pressing research integrity issue that has been well-documented. As a student-based group UAEM UK has a particular interest in the role that UK universities have in promoting research practices rooted in the concept of global health equity. We believe that universities have a responsibility to demonstrate best practice reporting because they are publicly-funded institutions and should therefore work in the best interest of the public. This is especially pertinent because the untimely and inadequate reporting of trial results has a proven negative impact for UK patients, taxpayers, and investors. 

There have been many attempts to enforce sanctions to improve reporting practice, however, sanctions are not severe enough and do not get consistently enforced. Compliance to these sanctions is therefore weak. In light of this, we are encouraged by the announcement that the HRA will monitor the reporting of clinical trial results and enforce stricter sanctions if results are missing. However, this will only begin to have an impact if it is enforced as soon as possible without delay. 

4. UAEM Evidence 

UK Universities have a scientific and ethical responsibility to encourage researchers to report trial results in a timely manner. In a paper published in 2021 (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05330-5) members of UAEM UK assessed whether the top thirty UK universities receiving the most funding from the Medical Research Council between 2017-2018 complied with the World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry. To do this, alongside other analysis, the authors designed an automated tracker that identified the number of registered trials that are due to report results. This enabled them to gain an overview of which of the universities had outstanding results and to quantify the average and median number of days between primary completion date and results posting. Overall, they found that 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. One conclusion drawn from this analysis is the need for greater incentive for UK sponsors who fail to upload publicly available trial results. Taking actions such as increasing the repercussions for not reporting will help to ensure that the detailed, timely and accurate reporting of clinical trials becomes the norm in order to facilitate evidence-based medicine and prevent harm to patients. 

5. The solution - the HRA must enforce this policy as soon as reasonably possible 

We argue that the HRA should enforce the suggested policy to improve the timeliness of trial reporting as soon as reasonably possible. This will firstly ensure that the policy is actioned and does not get buried amongst other issues. Moreover, clinical trial reporting is an immediate issue with active consequences. This is evidenced by a project UAEM UK has also been involved in, which found that only 19% of the Covid-19 clinical trial registrations studied had reported results (Results Availability and Timeliness of Registered COVID-19 Clinical Trials: A Cross-Sectional Study | medRxiv).

Clinical trial reporting is an issue that will shape our response to this pandemic, and those to come, if we do not incentivise best practice to ensure timely reporting of results. We therefore encourage the HRA to adopt the new policy as soon as reasonably possible to ensure that what we understand as best practice can become common practice sooner rather than later. 

(September 2021)