Improving protection of test subjects in clinical trials

In recent years, SOMO’s pharmaceutical team has focused on research and lobbying to safeguard the rights of test subjects in clinical trials that take place in low income countries. After the publication of ‘Putting Contract Research Organisations (CROs) on the Radar’ and a lobbying paper, SOMO continued its work behind the scenes with significant results. Here is an update of the developments in the past months.

Medicines for the European market are tested more and more frequently on test subjects outside of the European Union (EU), in low and middle income countries. In the past few years SOMO and Wemos have collected considerable evidence of violations of ethical principles and guidelines taking place in these trials. SOMO researcher Irene Schipper says about one important result:

“In 2012 the long lobby trajectory aimed at the European Medicines Agency (EMA) finally yielded results. A recent step taken in this trajectory was the briefing paper released in September 2011, written in collaboration with Wemos.”

Protection of clinical trial subjects in countries outside the EU

Public accountability of corporations

In the briefing paper the researchers describe the current situation and state their concerns. Above all, the European Parliament, the European Commission and the EMA are called upon to undertake the following steps:

1. Effective integration of the ethical principles in EMA procedures.
2. Improving the transparency of the clinical trials being held outside of the EU.
3. Strengthening capacity in low and middle income countries.

Schipper states: “This means that, for example, companies need to be accountable for the ethical aspects of their clinical trials; not only in the reports after the trials but also during the research stage.”

EMA follows recommendations

The EMA has included many of SOMO and Wemos’s recommendations in its ‘Reflection Paper on Clinical Trials Conducted in Third Countries for Marketing Authorisation in Europe’ of April 2012. This policy paper was written by the EMA, which was given the mandate by the European Commission to improve implementation of the existing legislation.

Schipper says: “This is a result we can be justly proud of. However, SOMO does have some questions regarding the phrasing in the EMA report and we are currently engaged in discussions with them on this. We continue to follow developments closely.”

Putting Contract Research Organisations on the Radar

‘Putting CROs on the Radar’ report?

Last year SOMO published the report ‘Putting Contract Research Organisations on the Radar‘. This research showed that clinical trials in low income countries engender more risks than had previously been demonstrated. The reason for this is that more than half of the trials are carried out by subcontractors and not all subcontractors are monitored. This jeopardises the quality of the clinical trial. Moreover, there is no independent supervision.

“In the period following the release of our report, more and more publications appeared on this subject, often referring to our report. India is the forerunner, with the subject receiving ample coverage there in newspapers and medical journals,” Schipper says.

Responses from readers of the report and the media attention have now led to a proposal for further talks with the industry association of CROs (ACRO).