Zimbabwe's clinical trial oversight leaves room for ethical violations

The supervision and monitoring of clinical trials in Zimbabwe faces serious challenges in protecting the rights of clinical trial participants.

Today, Wemos issues a report that describes flaws in the current system of clinical trials oversight. This is demonstrated by the story of an HIV-positive Zimbabwean woman attacked by blindness during her trial participation.

Late 2010, the young Zimbabwean mother Grace Mawere participated in a medical study that looked into second-line treatment for HIV patients whose first-line treatment is failing. During the clinical trial, Grace's vision declined and she was diagnosed with partial blindness.

It is plausible that the trial drugs caused her loss of eyesight. Sadly, neither the trial sponsor nor the principle investigator did properly investigate whether there was a causal link between the tested drugs and Grace's eyesight problems. As a result, she never received compensation or proper treatment. On 6 April 2014, Grace passed away.

"This case is a clear violation of both international and national guidelines[1] concerning medical research, requiring responsible actors to undertake proper measures to investigate and treat a serious side effect of the drugs," says Annelies den Boer of Wemos.

"Ensuring the rights and interests of trial participants is a fundamental requirement for drug testing. Also, not reporting and examining a side effect during a trial may lead to incomplete information about the drugs' side effects, which influences the reliability of the trial outcomes," she adds.

The story of Grace is a story unfolding against the backdrop of the Zimbabwean clinical trial landscape that raises several concerns. The report, written by the investigative journalist Terence Zimwara and published by the Amsterdam-based advocacy organization Wemos, clearly illustrates the vulnerability of the Zimbabwean clinical trial oversight system.

Institutions[2] charged with supervising trials lack capacity and non-compliance with regulations is often without consequences. A senior clinical trials official lists violations by researchers, which should be seriously questioned.

Examples are: researchers implementing unapproved studies, refusal to access sites for inspections and limited influence over research that is conducted in Zimbabwe. The weaknesses in the approval and monitoring process leave room for violations of the rights of the trial participants, as demonstrated by the case of Grace. These systemic flaws go unnoticed by the public due to a lack of transparency, limited public information and an almost complete absence of media coverage. Public awareness about the risks is pivotal. For a considerable part of the poorer population of Zimbabwe, participating in a clinical trial means having access to medical treatment.

Wemos believes that the report will contribute to increased awareness in Zimbabwe about the potential risks faced by trial participants. Den Boer emphasizes: "We urge regulators to make relevant and accurate information publicly available. This will enable the media to monitor the oversight system and share information with Zimbabwean people. Furthermore, strengthening the capacity of oversight bodies, empowering them to prevent and address any unethical conduct in medical research, is paramount."