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Clinical trials lawyer comments on importance of International Clinical Trials Day

International Clinical Trials Day is held on the 20th May each year

African child receiving vaccine

20 May 2016

International Clinical Trials Day is held on or around 20 May every year to commemorate the day when James Lind started his trial on the disease scurvy.

Lind, who was born in 1716, studied surgery in Edinburgh before joining the Royal Navy as a surgeon’s mate.  After leaving the navy he published a number of textbooks, including A treatise of the scurvy which contained details of a controlled test that he carried out on sailors with scurvy. This is believed to be the first randomised clinical trial to have been recorded.

Today International Clinical Trials Day is celebrated to focus on the importance of research to health care.  Clinical trials result in the production of data-base research evidence that influences the clinical and policy decision made by health professionals, policy makers and patients.

Pharmaceutical companies are extending the clinical trials that they conduct throughout the work, including in developing countries.  There are benefits to these programmes, for example, the global patterns of diseases can be more easily identified, and the delivery of public health services in developing countries can be helped by evidence from clinical trials.

However, the scrutiny of clinical trials in developing countries has to be rigorously maintained to ensure that participants in clinical trials in developing countries are not placed at greater risk than participants in, for example, the UK or US.

The high regulatory burden placed on pharmaceutical companies in developed countries must not be side-stepped by companies looking to make profits out of the development of products for consumers in developed countries by testing on ‘guinea pigs’ in countries where testing standards are not as high.

The protection of patients in a global market has recently led to regulatory bodies calling for more global regulatory drug and device harmonisation. In the same way that clinical trials are now carried out around the works, the development of global markets means that drugs and devices are often produced outside the countries where they are being used.

The former US Food and Drug Administration Commissioner Margaret Hamburg, and former National Institutes of Health Director Elias Zerhouni recently noted that regulatory authorities are struggling to keep up with advices in science and technology, as well as the complexity of product development, manufacture and supply.

Drugs and devices can be approved in one jurisdiction, but not another because of existing patterns of regulatory divergence.

Regulatory harmonisation could help countries with limited regulatory capacity, and could lead to the improved protection of patients around the world.  

Without international cooperation on the regulatory of clinical trials, as well as harmonised standards around the production, manufacture and distribution of drugs and devices patients will continue to be at risk of exploitation.

In August 2015 the European Medicines Agency suspended marketing approval for a number of medicines which it had authorised after receiving data from clinical studies carried out in Hyderabad in India.

The action was prompted by an inspection of the Hydrabad site by the French medicines agency which uncovered data manipulation of electrocardiograms throwing doubt on the reliability of the data.

Further ethical challenges remain and continue to be reported.  An article in the Lancet in 2014 noted that a clinical trial was carried out in India between March 2011 and November 2012 into an experimental vaccine for rotavirus, the most common cause of severe dehydrating gastroenteritis in developing countries.

During the trial one third of the infants, more than 2,000 children, were given placebo injections rather than an available effective vaccine against the viral infection, thus exposing them to a life-threatening virus.

The trial was funded by numerous US private and government sources and would not have been permitted in the US.

The existence of a single international standard of ethical research would have protected the children in the Indian trial.

The development of Europe-wide standards on clinical trials on medicines for human use has taken a step forward with the publication of Regulation (EU) No 536/2014 which is due to come into force at the end of May 2016.  

Clinical trials lawyer Gene Matthews comments:

“The development of international safety standards has been identified as a priority by regulatory authorities around the world.  While I welcome EU Regulation 536/2014 coming into force, it is clear that this is a global, and not just a European health issue. 

"We all need drugs to be safely developed and this requires appropriate regulation and supervision of drug development.   We cannot allow any country to be considered as a place that corners can be cut and drugs inappropriately rushed to the marketplace”

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