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Strengthening standards for clinical research
MAIDENHEAD, U.K.—Even as Brexit (the colloquialism for Britain’s exit from the European Union) looms over the United Kingdom, protestors recently spilled into the streets of London carrying signs saying, “Stay in the EU.” On March 29, the European Union’s Article 50 was triggered, launching a two-year countdown to Brexit, during which a deal must be settled between the United Kingdom and the EU.
Amidst the political and economic discord stands the fate of clinical research, which may be in peril, according to the IAOCR, the accrediting organization for the international clinical research industry. IAOCR leaders believe, however, that new competency requirements will revive clinical research in the United Kingdom.
“The competence of those undertaking clinical trials is inherently important from both an ethical and commercial perspective,” says Jacqueline Johnson North, CEO of IAOCR. “By including competence as a requirement, the guidelines will ensure clinical research is carried out more effectively and efficiently, thus enabling the bringing of new treatments to market quicker.”
Not leaving anything to chance, the IAOCR called an emergency summit meeting with industry leaders for April 5 to discuss what measures need to be taken pre- and post-Brexit, with the focus on protecting the current and future talent of the clinical research industry, as well as defining other key issues that the industry needs to consider as the United Kingdom prepares to exit the EU.
The IAOCR is also creating a taskforce to develop a practical, strategic positioning paper with clear messages on what the clinical research industry needs to survive and thrive pre- and post-Brexit.
“If our industry is to attract and retain talent in the UK, both now and in the future, the implications of Brexit need to be considered and we need to take positive action,” the IAOCR states. “We need to ensure that we put in place measures to safeguard the highly valuable talent that we currently employ and plan for future talent development.”
Improving the health of UK life sciences has been highlighted as an important reason to leave the EU by the pro-Brexit campaigners, who characterize European regulation of clinical research as inept, choked by meaningless bureaucracy and hopelessly uncompetitive with the rest of the world.
“The aim of providing someone with education, training and experience is to enable them to become competent,” Johnson North says. “However, education, training and experience do not necessarily qualify someone to do a job properly and, therefore, competence needs to be checked.”
“Competence assessment is a business process that should be part of an ongoing quality assurance system,” she says. “Whilst competence is the end destination, the journey towards competence should never be considered complete because competence levels do not stay static. Often, clinical research companies tell us that their more experienced team members are the ones that cause the highest number of quality issues. Therefore, a risk-based approach to competence monitoring and appropriate interventions needs to be implemented.”
Increasingly, according to the IAOCR, “clinical research organizations are recognizing the flawed concept that education, training and experience is a reliable measure of expertise. Many are proactively adopting a competence-based approach to workforce quality, with three of the top five global clinical research organizations and a number of industry membership bodies benchmarking against IAOCR’s frameworks and processes. Furthermore, although not yet mandated by the guidelines, regulators are increasingly asking for evidence of competence.”
The IAOCR is helping to address issues such as these by working with a group of sponsors and clinical research organizations to develop next-generation programs for undergraduate and master level apprenticeships in clinical research. The programs are due to launch early 2018.
“Poor workforce effectiveness leads to errors and inefficiencies, thus delaying the successful completion of clinical trials,” Johnson North says. The combination of workforce inefficiencies and a restricted talent pool is a serious impediment to new treatments being made available to the patients who need them, she adds.
With governments becoming increasingly focused on reducing red tape to bring new treatments to market quicker and at lower costs, there is growing pressure on sponsors and their partner organizations to increase efficiencies, the IAOCR states. Mandating an effective competence-based approach would help ensure that resources are not wasted on ineffective working practices or redundant training, and vendor oversight activities could be reduced while at the same time improving quality standards.
But not everyone is convinced more regulations or stricter requirements will help the clinical research industry.
The Clinical Trials Directive (CTD) was implemented in 2004 with the aim of standardizing best practices for clinical trials in Europe, yet U.K. Justice Secretary Michael Gove criticized the EU’s CTD for “slowing down the creation of new drugs to cure terrible diseases.”
A February 2016 opinion piece published by London-based business newspaper City AM argued the CTD “contributed to a decline in the number of applications for clinical trials and increased costs and delays in setting them up in the U.K.”
Angus Dalgleish wrote in The Telegraph on Oct. 7, 2016, “My experience on the cancer commission of an EU ‘Framework Programme’ was that major decisions were determined by lobbying—and not by peer-reviewed decisions.”
The IAOCR was founded in 2011 in response to industry demand for competence standards and assessment, Johnson North says. Over the last two years industry awareness of the competence anomaly has increased dramatically, with the industry is becoming more vocal about the need for change.