Throughout history, clinical trials have played a key role in informing scientific research and developing some of the world’s most advanced medical treatments. In the modern age, however, companies must also ensure that the trials they fund are compliant with law and capable of maintaining the safety of participants at all times.
This was borne out recently, when dozens of clinical trials were revealed to contain suspicious statistical patterns that may be indicative of inaccurate or falsified data.
A study, which used statistical tools to identify anomalies hidden in the data sets, has unsurprisingly prompted a widespread investigation into the trials. It has also raised concerns about the reliability of trial findings and the role that the law plays in regulating such studies in the UK.
What are Clinical Trials?
In simple terms, clinical trials are research studies and programs that are designed to evaluate a surgical, medical or behavioural intervention.
In most instances, they’ll analyse the impact of a new drug, diet or medical device in real-time, paying attention to its performance and any side-effects that are triggered in participants.
The ultimate goal is to ensure that a potential treatment is effective and safe for consumption, whilst individual trial subjects are usually measured against existing alternatives in the marketplace.
How are Clinical Trials Currently Regulated in the UK?
Between 2004 and the present day, clinical trials in the UK have been regulated by the EU Clinical Trials Directive, which outlined a standard set of guidelines for businesses and laboratories throughout Europe.
The most up-to-date legislation was rolled out earlier this year, after the EU agreed to address some concerns of its member nations pertaining to the bureaucratic burden and cost of running clinical trials in the UK and similar nations.
Many of the recently unveiled changed were agreed back in 2014, including the introduction of a new, EU-wide portal and database to provide a single point of entry for all clinical trials in the single bloc.
The new guidelines will also drive greater transparency across all clinical trials, whilst simplifying the application process and allowing for faster innovation.
The Importance of Recognising the Legalities of a Clinical Trial
With the UK set to leave the EU on January 31st, 2020 (although this may be subject to change), the government may choose to repeal the existing legislation and pass new clinical trial standards at some point in the near-term.
In the meantime, however, it’s important that firms continue to familiarise themselves with the legal implications of conducting clinical research in the UK. From the underlying ethical issues to the rights of participants, there’s a diverse body of legislation that businesses must get to grips with before funding and carrying clinical trials.
It’s also important to note that much of the clinical research and trial law in this space is relatively recent, meaning that you may need to partner with industry experts such as Gallagher to protect your interests adequately.
When driving compliance, you must pay particular attention to the standards and duty of care and informed consent, whilst there’s a pressing need to tackle any potential conflicts of interest and address these before committing to a formal trial.