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 A lot of this information is unpublished, but is used by the Therapeutic Goods Administration (TGA) when it evaluates new drugs.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.




manufacturer provided the clinical evaluation
manufacturer provided additional useful information
manufacturer provided the AusPAR and/or the product information
manufacturer declined to supply data
manufacturer did not respond torequest for data

Table - Pharmaceutical company responses to requests for clinical evaluation data January 2011 – December 2013

manufacturer provided the clinical evaluation
AstraZeneca vandetanib
Norgine rifaximin
Sci Gen zonisamide
Shire lisdexamfetamine
Vifor Pharma ferric carboxymaltose
manufacturer provided additional useful information
Actelion collagenase Clostridium histolyticum
Boehringer Ingelheim linagliptin
Bristol-Myers Squibb dapagliflozin, ipilimumab
Celgene romidepsin
CSL meningococcal vaccine
GlaxoSmithKline dabrafenib
Janssen-Cilag canagliflozin, prucalopride
Leo Pharma ingenol mebutate
Merck Serono sapropterin
Merck Sharp & Dohme boceprevir, nomegestrol/oestradiol
Sanofi-Aventis cabazitaxel, teriflunomide
Sanofi Pasteur live Japanese encephalitis vaccine
Schering-Plough corifollitropin alfa
Shire velaglucerase
Specialised Therapeutics fidaxomicin
Takeda alogliptin
manufacturer provided the AusPAR and/or the product information
AstraZeneca ceftaroline, ticagrelor
Bayer aflibercept
Biogen fampridine
Biogen Idec dimethyl fumarate
Bristol-Myers Squibb saxagliptin
CSL tapentadol
GlaxoSmithKline belimumab, eltrombopag, measles, mumps, rubella and varicella vaccine
Ikaria terlipressin
Janssen-Cila abiraterone, rilpivirine, telaprevir
Lundbeck rasagiline, sertindole
Merck Sharp & Dohme tafluprost
MS Health mifepristone
Novartis canakinumab, fingolimod
Novo Nordisk liraglutide
Pierre Fabre Medicament vinflunine
Roche pertuzumab, vemurafenib, vismodegib
Pfizer axitinib
Specialised Therapeutics palonosetron
manufacturer declined to supply data
Bristol-Myers Squibb apixaban
Schering-Plough asenapine
manufacturer did not respond to request for data
Link Medical Products cyclizine
Novartis ruxolitinib