 European editor, phone +44 1244 538583, philipward1@btconnect.com

Philip Ward

	Fraud prevention requires good research governance, clear peer review of activity, and mechanisms in place to investigate any allegation, and regular review of data and investigation of suspicious data, according to an experienced UK clinical researcher. Encouraging a whistleblowing culture, monitoring reports acted on by sponsors, understanding that mistakes can happen, and an open policy to “own up” are also vital.

	“Fraud seriously undermines the integrity of clinical research as a whole,” says Steve McSwiggan, PhD, deputy director of the Edinburgh Clinical Research Facility at National Health Service (NHS) Lothian. “The onus must be on all staff to raise any suspicions with a line manager or superior.”

	Clinical trial fraud is more prevalent than is thought, but is still rare, he added. The literature is littered with examples of fraud, despite most cases being dealt with in-house, and fraudsters tend to be lone workers or those who are so exalted that their work cannot be challenged.

	The consequences include damage to an individual’s reputation, damage to an institution’s reputation, erosion of scientific trust, dangers for patients (data used may lead to unsafe medications being licensed), and denying patients access to potentially useful treatments, according to McSwiggan, who was formerly the head of commercial research services at the Tayside Medical Science Centre (TASC), University of Dundee/NHS Tayside, UK. Furthermore, the time spent validating data increases costs and reduces the time spent on building new knowledge, and fraud leads to returned fees/grants, delays in review, cost of investigations, reanalysis of data, etc.

	McSwiggan believes it’s important to distinguish between fraud (use of deception with the intention of obtaining personal gain, avoiding an obligation or causing loss to another party) and research misconduct (fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results). In the UK, the most relevant legislation is the Medicines for Human Use (Clinical Trials) Regulations Statutory Instrument (2004, No. 1031), and the legislation for Clinical Trial of an Investigational Medicinal Product (CTIMP), which lays down 14 principles and conditions of good clinical practice (GCP).

	McSwiggan, who spent six weeks treating Ebola patients in West Africa in 2015, noted that other types of clinical trial fraud include forging (invention of false or misleading data), cooking (only analyzing data that supports a hypothesis), trimming (smoothing out data), misuse of statistics (use of improper techniques), and irresponsible authorship.

	Determining a local approach that works is important, he continued in his presentation posted on the TASC website (view 

). For instance, NHS Tayside has a whistleblowing policy, code of corporate governance (including fraud standards), and a fraud liaison officer. The University of Dundee has a code of policy and procedures for investigating and resolving allegations of misconduct in research and a whistleblowing code.

	To illustrate his key points, McSwiggan gave details of three notable case studies. Evidence suggests these are not isolated cases of misconduct, McSwiggan pointed out. The Commission on Research Integrity in Washington found in 1996 that 36% of doctoral and post-doctoral students were aware of an instance of scientific misconduct, and 15% were willing to do whatever was necessary to get a grant or publish a paper. A survey of members of International Society for Clinical Biostatistics in 2000 revealed that 51% of respondents knew of fraudulent projects.

	A review of 650 FDA inspections conducted between 1998 and 2013 led to 57 official actions. There were 22 cases of falsified information, 14 cases of researchers who failed to report adverse events, 42 cases of violations of the trial’s protocols, 35 cases of record-keeping errors, and 30 cases of researchers who failed to protect patient safety or to acquire informed consent.

Articles

Expert outlines approaches to preventing fraud in clinical research-a more prevalent problem that many believe.

What Can You Do to Prevent Clinical Trial Fraud?

European Federation of Pharmaceutical Industries and Associations

) has provided further evidence of the potential health risks posed by the upcoming relocation of the European Medicines Agency (EMA).

	In a statement, EFPIA says its latest survey underlines the scale and importance of the issues posed by the Brexit discussions and shows how much Europe’s integrated supply chains rely on the U.K. The key findings are as follows:

	• There are over 1500 clinical trials being conducted in multiple EU member states that have a UK-based sponsor. Over 50% of these trials are scheduled to continue beyond March 2019.

	• 45% of EFPIA members expect trade delays if the U.K. and Europe fell back to WTO rules. To prevent these delays, the EU and UK should agree a comprehensive agreement that ensures maximum alignment between EU and UK pharmaceutical laws, it states.

	• Over 12,000 centrally authorized marketing authorizations (MAs) for medicines will require a separate MA in the U.K. in order for the medicine to be prescribed to patients. Approximately 17% of centralized MAs are held in the UK.

	• Over 2600 final medical products have some stage of manufacture based in the U.K.

	• 45 million patient packs are supplied from the U.K. to other European countries each month. Over 37 million patient packs are supplied from the rest of Europe to the U.K. each month.

	“The survey underlines the scale of the task ahead,” commented EFPIA Director General Nathalie Moll. “For life-saving and life improving medicines, the EU and U.K. cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the U.K. leaves the EU.”

	The findings emphasize the importance of scientific research collaboration between the U.K. and EU, according to EFPIA.

	“Even in the context of the Brexit negotiations, where all sectors are looking for clarity on the future, it is important to recognize that the medicines sector is different. The medicines we make impact directly on peoples’ health,” she said. “Securing ongoing cooperation on medicines regulation between the U.K. and EU is the best way of ensuring that patients across Europe continue to have access to safe and effective medicines.”

	A summary of the EFPIA survey results is available 

EFPIA Voices Fresh Concerns on EMA Relocation

	European Union (EU) member states are due to select a new host city for the European Medicines Agency (EMA) on November 20, 2017, after which the EMA will have just over 17 months to conclude its move and start operating in its new HQ by the end of March 2019, according to a statement issued by the agency on November 7.

	EMA admits the relocation will be a challenging task, made even more complex by the “ambitious timetable” determined by the withdrawal of the U.K. from the EU. Effective collaboration between the agency and the new host country will be essential. Furthermore, EMA says it is committed to giving stakeholders and the public full visibility of the relocation project, and in early December it will make publicly available a monitoring chart that tracks the progress.

	According to the statement, “The most pressing issue that needs the immediate attention of EMA and the host country is the agency’s new premises. Many administrative steps need to be taken before work on the new building can begin.”

	EMA’s building plans need to be approved by the relevant local authorities, as well as its own management board and the EU budgetary authority. This process typically takes between six and eight months. Fitting out the new premises is expected to take between 12 and 15 months. Also, schools for around 600 children of EMA staff members, and affordable, good quality housing for up to 900 households must be found.

	EMA has pledged to provide further updates on the implementation of its business continuity plan as they become available.

Decision on EMA Relocation is Due on November 20

	The considerable uncertainty caused by Brexit is proving a goldmine for conference organizers, it seems. The Drug Information Association (DIA) is the latest group to put together a meeting about this hot topic.

	“Brexit will have a considerable impact on the regulation and supply of medicines to patients,” noted the DIA in a statement. “With the time frame for Brexit fast elapsing, governments, regulators, companies, healthcare systems, and patients are all seeking to prepare for the “known unknowns” and to brace for the “unknown unknowns”. However, information is scarce and not always accessible or confirmed.”

	At its meeting to be held in London on December 8, DIA plans to bring stakeholders together to share their knowledge about operational and strategic measures being taken to prevent or minimize the impact of Brexit.

	According to the organizers, “With the clock ticking, stakeholders will consider explicitly in this conference the dimension of time in shaping what opportunities for action companies-and indeed all stakeholders-must consider.”

	The closing session, called Brexit time check: "what’s next for medicines?”, will be chaired by ACT columnist Peter O’Donnell. The aim is to investigate the broader level vision of what’s coming next in the Brexit schedule of change.

	For the full program and further details, 

Author | Philip Ward