clinical trials
6 February 2007
Today, I convened a meeting with the researchers involved in at least 5
microbicide clinical trials that are taking place in South Africa.
The meeting follows the disturbing news about the preliminary results of the
study conducted amongst a group of 604 women in KwaZulu-Natal, to test the
effectiveness of a vaginal microbicide, cellulose sulphate gel, in preventing
the sexual transmission of HIV.
The purpose of the meeting was to establish the details with regard to the
interim results of the cellulose sulphate study and gain further insights into
the other microbicide trials that are underway in the country.
Health research which includes the conduct of clinical trials as one method
of research is a critical component of advancement of health sciences. In
addition, it contributes to improved management of various health conditions.
However, ethical practice of research has become a major concern in health
research over the past few years, particularly regarding the vulnerability of
research participants.
South Africa provides a unique environment for research. The former
advantaged areas of our country have good infrastructure, skilled researchers
and well-equipped research institutions comparable to many developed countries.
The rest of our population is affected by the burden of diseases common to many
poor, developing countries particularly in sub-Saharan Africa.
Increasing research activity, competition and attractive research
environment may sometimes have undesired outcomes.
That is why the Department of Health has been making efforts to ensure that
research is conducted in an ethical manner. Over the past years, the Department
has put in place several mechanisms to ensure good research management.
We have produced Good Clinical Practice Guidelines as well as Ethics
Guidelines which spell out the responsibility of researchers, research sponsors
and other authorities to research participants. These guidelines are
enforceable in terms of the National Health Act of 2006.
With regard to this particular study in KwaZulu-Natal, I have asked the
National Health Research Ethics Council to conduct a thorough investigation
into this matter. The Ethics Council which has been established in terms of the
National Health Act, commenced its functions last month.
This investigation should establish:
* Whether the study followed all protocols approved by the
Medicine Control Council (MCC) and the Ethics Committee of the relevant
research institutions
* Whether the participants were given sufficient information to make informed
decisions about their participation
* and any other issue that might shed light on the preliminary results and
their implications for the participants of this study and other similar
clinical trials.
We have also requested the Ethics Council to look into the other microbicide
trials that are registered in the country and satisfy itself that these trials
are being conducted in terms of the required protocols.
We have asked the Independent Data Monitoring Committee that was overseeing
the trial to make available as soon as possible all the information relating to
the South African arm of the trial.
While we support innovation through health research, the government of South
Africa is determined to ensure that the health of our people is not compromised
in the process.
Dr Manto Tshabalala-Msimang
Minister of Health
For further information, please contact:
Sibani Mngadi
Cell: 082 772 0161
Issued by: Department of Health
6 February 2007
