New drugs: transparency

Access to the information collected during clinical trials is important for preparing the new drug comments in Australian Prescriber. A lot of this information is unpublished, but is used by the Therapeutic Goods Administration (TGA) when it evaluates new drugs. Australian Prescriber routinely asks pharmaceutical companies to provide a copy of the clinical evaluation data which support the safety and efficacy of their products. Few companies provide this level of transparency.

Almost 10 years ago Australian Prescriber started to publish a rating of the companies’ cooperation. This was called the T-score (see box). While some companies are willing to provide data, others do not even respond to the request for information (see Table).

In the last few years the TGA has started to publish information about what was considered when it evaluated a new drug for the Australian market. These Australian Public Assessment Reports (AusPARs) include information from the TGA’s clinical evaluation. This then resulted in some companies, responding to requests for data, referring Australian Prescriber to the AusPAR rather than providing the data. As the AusPAR is a public document and does not contain the full clinical evaluation, the Editorial Executive Committee decided that companies which only provided an AusPAR would be given the minimum T-score.

To be advised to read the AusPAR is particularly unhelpful if the AusPAR has not been published before the drug is launched onto the Australian market. The TGA is working to reduce this delay in publishing AusPARs. In addition, the TGA has been providing extracts of its evaluations, as attachments to the AusPARs, since July 2013.

The transparency of drug regulation is gradually improving, but Australian Prescriber will continue to monitor the willingness of the pharmaceutical industry to provide information about clinical trials of new drugs.