If we choose to leave the EU on 23 June, we won't know for certain what the impact will be. A strong body of evidence has been presented by the medical research community which supports the remain campaign, but is the unproven alternative truly less attractive? As an academic exercise, compare this decision to the one we ask patients to make when given the choice of whether or not to take part in a clinical study: a proven and approved treatment option versus all the unknowns of study participation (randomisation, the investigational product). It's a wonder anyone takes part! Today, on International Clinical Trials Day, there are fewer than the proverbial 40 days left in which to make a decision.   

This summary of opinions in recent months, for and against Brexit as it affects medical research, includes a bias towards cancer research which despite a seemingly high public profile has very low clinical study participation levels. 

Those against Brexit

In a letter to The Times in early March, Royal Society fellows commented that Brexit would be a “disaster for UK science” citing two main reasons for this opinion: “increased funding has greatly raised the level of European science as a whole and of the UK in particular” and “we now recruit many of our best researchers from continental Europe, including younger ones who have obtained EU grants and have chosen to move here with them.” This view was echoed by the Lords Science and Technology Committee in April which, according to the Guardian's science editor, Ian Sampler, “stressed the importance of the EU for collaborative projects and the free movement of researchers”.

Sir Paul Nurse, director of the Francis Crick Institute, and members of the European Cancer Concord were published in the April issue of The Lancet Oncology sharing their view that we should remain part of the EU. They stated that this will allow the UK to “continue to influence and share European policy in important domains such as clinical trials and clinical best practice, and deliver the highest quality cancer research that underpins improved cancer care for our patients”. 

In the same journal, current president and 2018/19 president-elect of the European Society for Medical Oncology (EMSO), Professor Fortunato Ciardiello and Dr Josep Tabernero, also supported the remain campaign: “With a British departure, both sides would be missing powerful and irreplaceable influencers in our unified ambitions aimed at conquering cancer”. They added, “Postexit uncertainty would inevitably affect European oncology research and care and would necessitate a lengthy period of adaptation as we grapple with the aftermath.”

In a letter to the Observer in May, 93 business leaders and organisations in the life science industry wrote: “The life-science sector makes an important contribution to the health and wealth of the UK. The sector employs over 222,000 people across the UK. It spends £4bn on R&D, and also attracts high levels of inward investment - government support has led to some £6bn in the last five years alone.” The group included big pharma's top three - GlaxoSmithKline, AstraZeneca and Pfizer.

In the interests of balance

In February, Karen Taylor, research director for Deloitte's UK Centre for Health Solutions, authored a corporate blog on the potential impact of Brexit for the pharmaceutical industry. Under the sub-heading 'regulation and clinical trials processes', she mentioned that Brexit could mean relocation of the European Medicines Agency (EMA) which is currently based in London's Canary Wharf, adding: “The level of disruption following a Brexit would depend on whether the UK remained part of the European regulatory framework. If not, the UK will have to resume separate authorisations and inspections leading to duplication and delay.” However, she also mentioned that “… it could still be possible to remain under the EMA's umbrella, as demonstrated by Norway and Iceland, a move that could be seen as mutually beneficial”. 

Many who would like to leave the EU cite the 2004 Clinical Trials Directive (CTD) as a major factor for this view. In late February, Chris Lo wrote in Pharmaceutical Technology: “The CTD has proven broadly unpopular among scientists as it has added cost, complexity and reams of regulatory red tape for researchers wishing to carry out trials in Europe. It is also true that after the CTD's implementation in 2004, clinical research took a nosedive in many areas - in the UK, non-commercial trials dropped from 600 between 2000 and 2003 to fewer than 300 between 2004 and 2007.” However, he also stated that: “new, improved clinical trial rules are set to be introduced in Europe in 2017… [and] … extensive reform looks to have addressed the majority of concerns and a centralised gateway for clinical trial applications would be of huge significance.” 

At the coalface 

There is no doubt that medical research is a vital component of a humane society which aims to improve patient outcomes through the development of new treatment options. While the EU referendum has brought medical research into sharp focus at a macro level, patient recruitment continues to be one of the greatest challenges facing researchers.

In a 2013 issue of the British Journal of Cancer, Jenkins et al investigated 'Drivers and barriers to patient participation in RCTs' - a Cancer Research UK-funded prospective study. The purpose of the study was “to provide evidence-based arguments that might encourage HCPs to approach more patients about trials”. Among its conclusions, the study found that “HCPs' perceived attitudes are powerful influencing factors”. 

But it is not only the research teams themselves that have an important role to play in the successful enrolment of clinical studies. Referral networks are valuable sources of potential participants. At a recent investigator meeting, the top recruiter to a non-small cell lung cancer study described how HCPs in Turkey use a closed social media platform to share the titles of the studies they are running and to refer patients to each other. 

Another interesting idea was floated at last year's eyeforpharma conference in Barcelona, where patient advocate Jack Whelan suggested that pharma should invest in educating primary care practitioners about clinical studies rather than educating patients. His comments featured in a PMLiVE article, where he said: “Most patients don't participate in research in clinical trials because we are never asked.” Past surveys by Harris Interactive and CISCRP have highlighted the same issue, with results showing that the vast majority of patients would have considered clinical study participation had they known about it.

As the case is made for and against Brexit over the next few weeks, many more views and opinions will be shared. This summary may help to capture the key points of what is becoming an almost overwhelming amount of information. Decisions, decisions…