8.6.1 Clinical trials regulation at work
The conduct of clinical trials is regulated in all the countries, except Cyprus. In Cyprus, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new drug. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of Clinical Trials under the Ministry of Health, which performs clinical trials on drugs produced within the country.
Regulation of clinical trials through use of a specialized ethics committee at the trial site constitutes a decentralized approach. This approach is used in the Netherlands, where a local medical ethics committee at the site of the trial is responsible for the evaluation.
In Australia, approval of clinical trials involves both the regulatory authority and an ethics committee. Under the Clinical Trial Exemption (CTX) scheme, a clinical trial proposal must first be evaluated by the TGA, and then approved by an ethics committee on-site. Under the Clinical Trial Notification (CTN) scheme, a trial is evaluated and approved by the local ethics committee, and then notified to the TGA.
Differences in the systems used to regulate clinical trials in Australia and the Netherlands illustrate how the delegation of authority affects the ability of the central agency to monitor the working of the entire system. In Australia, all approved clinical trials must be notified to the TGA. There is no such reporting requirement for the MEB in the Netherlands. Information about the number and details of clinical trials conducted in the Netherlands is therefore not readily available to the MEB.
The majority of these countries have guidelines for evaluating clinical trial proposals. All of them are consistent with the Ethical Principles for Medical Research Involving Human Subjects (the Helsinki Declaration) and also conform to the WHO Guidelines for Good Clinical Practice for trials on pharmaceutical products. This reflects the general trend towards harmonization of standards and norms in technical areas, as well as in drug regulation, as discussed in Chapter 4.
8.6.2 Performance
Quantitative data indicate a general increase in the number of clinical trial applications in Australia, Cuba, Estonia, Malaysia and Venezuela for the period 1994-97. Figure 8.11 shows the four-year average number of clinical trial applications received by the relevant authorities in these countries. During this period, the number of clinical trial applications in Australia far exceeded those received in all the other countries combined. The same is also true when the number of applications is computed against the number of new drug applications (Figure 8.12).
Table 8.5 Control of clinical trials
| |
Australia |
Cuba |
Cyprus |
Estonia |
Malaysia |
Netherlands |
Tunisia |
Uganda |
Venezuela |
Zimbabwe |
Control of clinical trials |
• |
• |
 *
|
• |
• |
• |
• |
• |
• |
• |
Approving body |
Local ethics committees** |
DRA |
N/A |
DRA & regional ethics committees |
DRA |
Local medical ethics committees*** |
Specialized commission but approved by Min of Health |
NDA |
INH |
As part of MCAZ |
Guidelines |
• |
• |
N/A |
Yes, procedures of committee of medical ethics for clinical trials |
Yes, set up by the Research Committee of the Ministry of Health |
• |
• |
• |
Yes, norms and regulation of research in clinical pharmacology |
No, applications are sent to external experts for evaluation |
Consistency of guidelines with:
a) Helsinki Declarationa |
• |
• |
N/A |
• |
• |
• |
• |
• |
• |
- |
b) WHO guidelinesb |
• |
• |
N/A |
• |
• |
• |
• |
• |
• |
- |
• = Yes = No - = data or information not available N/A = Not applicable
* Clinical trials are not allowed in the country.
** All clinical trials must be notified to the Therapeutic Goods Administration.
*** Notification or approval by the drug regulatory authority not required.
a Ethical Principles for Medical Research Involving Human Subjects.
b WHO Guidelines for Good Clinical Practice for trials on pharmaceutical products.
Figure 8.11 Average number of clinical trials, four-year average*
* No data available for Cyprus and the Netherlands
Figure 8.12 Number of clinical trials requested per new drug application*
* No data available for Cyprus, the Netherlands or Uganda.
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