On this page: Number of responses | Questions | Conclusions

Number of responses

There were a total of 105 respondents to this survey.

The absolute numbers of responses to each question are detailed in Appendix 1.

Questions

Question 1: What is your email address?

There were 84 responses to this question. This question was optional.

Question 2: What is your organisation?

There were 83 responses to this question. This question was optional.

Of the 83 responses, the vast majority (n=71, 86%) were from the pharmaceutical industry. Question 3 below gives a more detailed description of the survey respondents.

Question 3: Which group best describes you?

There were 108 responses to this question. Respondents could provide more than one response. This question was mandatory.

The majority of survey respondents (68%) were from the pharmaceutical industry (Figure 1). A much lower percentage (10-14%) comprised health care professionals or government employees. Nearly 4% were medicines regulators. No responses were obtained from those in the media.

Figure 1: Which group best describes you?

Question 4: Which country do you reside in?

There were 105 responses to this question. This question was mandatory.

The majority of respondents were from Australia (90%; Figure 2), with a small number of respondents from Singapore (n=4), the USA (n=3), India (n=2) and Spain (n=1).

Figure 2: Which country do you reside in?

Question 5: Which AusPAR document(s) do you mostly access?

There were 215 responses to this question. Respondents could provide more than one response. This question was mandatory.

Although most respondents said they accessed the AusPAR itself (83%; Figure 3), 56 65% said they also accessed the Extract from the Clinical Evaluation Report (CER) and/or the Product Information (PI) document.

Figure 3: Which AusPAR document(s) do you mostly access?

Question 6: How often do you access AusPAR pages?

There were 105 responses to this question. This question was mandatory.

The majority of respondents (54%) accessed AusPARs only when they were published on certain drug classes (Figure 4). Nineteen per cent of readers said they accessed AusPAR pages every time a new AusPAR was published. Just over a quarter of the responders (27%) rarely accessed the AusPAR pages.

Figure 4: How often do you access AusPAR pages?

Question 7: What do you use the AusPAR information provided for?

There were 105 responses to this question. This question was mandatory.

A small number of respondents reported that they used AusPARs for academic research or medical practice interest (3-5%), while a slightly higher number declared that they used AusPARs for government related work or personal interest (10-11%).

The majority of respondents to this question answered that they used AusPAR information for a category 'Other' than those listed (50.5%; Figure 5). Out of these 'Other' responses, about 40% said they used the information for 'regulatory intelligence', that is, to understand dossier issues, to gain insights into the regulatory decision-making process, and to understand the course of evaluations and trends in the TGA's perspective on drug development programs and regulatory decision making. It was also mentioned that AusPARs were used to understand regulatory hurdles faced by other companies when seeking to register similar therapeutic products.

Approximately thirty per cent of responses said that AusPAR information was used for writing medicines information; to inform clinical and economic evaluations, training, teaching and research; as a reference or guide to new medicines use and administration; and to keep up to date with new approvals and new indications.

A smaller number (-20%) of the 'Other' responses described AusPAR information being used as 'competitor intelligence', that is, to gain regulatory information on competitors and the competitors' data submitted to the TGA.

Figure 5: What do you use the AusPAR information provided for?

Question 8: How well would you say the AusPAR documents serve their purpose of providing transparency of the TGA's decision process of prescription medicines?

There were 105 responses to this question. This question was mandatory.

Nearly 80% of the respondents felt that AusPAR documents served their purpose of providing transparency of the TGA's decision-making processes of prescription medicines very well or well (Figure 6). One fifth of the respondents felt that AusPARs only somewhat fulfilled this purpose. Three per cent of responders felt that AusPAR documents did not fulfil this purpose at all.

Figure 6: How well would you say the AusPAR documents serve their purpose of providing transparency of the TGA's decision process of prescription medicines?

Question 9: How useful are the AusPAR document(s) for your needs?

There were 105 responses to this question. This question was mandatory.

Eighty-three per cent of the respondents answered that AusPAR documents were very useful or useful to their needs (Figure 7). Fifteen per cent felt they were somewhat useful, and 2% felt they were not useful at all.

Figure 7: How useful are the AusPAR document(s) for your needs?

Question 10: How likely are you to access information contained in AusPAR document(s) in the future?

There were 105 responses to this question. This question was mandatory.

Seventy per cent of respondents said they were very likely to access the information contained in AusPAR documents in the future (Figure 8). Seventeen per cent responded that they were likely to use AusPAR documents again, and 11 % that they were somewhat likely. A small number (3%) responded they were unlikely to access the information in AusPARs again.

Figure 8: How likely are you to access information contained in AusPAR document(s) in the future?

Question 11: What additional information might you like to see included in AusPAR documents?

There were 44 responses to this question. This question was optional. Of the 44 responses, nearly a quarter (n = 10, 23%) said that they would like to see a plain English, consumer-friendly summary included with each AusPAR.

Eight survey responders (18%) would like to see an improved AusPAR structure or a more detailed description of the decision and the rationale for the outcome, particularly where rejections and appeals are described in an AusPAR. It was also mentioned that a submission's chronology could be better presented, for example, questions raised by the evaluator should be followed by the sponsor's responses and TGA's resolutions in the same space. This would avoid the reader having to go through the whole document to find answers and resolutions.

Sixteen per cent (n = 7) of comments raised the unpredictability of AusPAR publication timing.

Eight respondents included suggestions for improvement and more information they would like to see in AusPARs, for example, details of PI negotiations, details of publications of clinical trials, application submission dates, and more information on quality and nonclinical data. One responder also proposed TGA publish AusPARs for medical devices.

Two survey respondents raised the issue of commercially confidential information being included in AusPARs,^[1] while one respondent was concerned about the prospect of industry influencing AusPAR content.^[2]

One response stated that they would prefer for AusPARs not to be published.

Four responders commented that AusPARs were useful, well presented, and showed good transparency of the TGA's decisions.

Two survey responders also identified improvements that could be made to the AusPAR landing page on the TGA website. Currently, AusPAR documents are only identified by a date and a broad description of the application type, which makes it difficult to identify AusPARs for a particular indication or variation without accessing individual documents.

Other respondents commented on the quality and nonclinical aspects of AusPARs, Orphan Drug Designation, and PI documents.

Conclusions

AusPAR audience

The majority of AusPAR readers were from the Australian pharmaceutical industry. A much smaller number were health care professionals, government employees or medicines regulators.

What are AusPARs used for

In line with the majority of AusPAR readers being from the pharmaceutical industry, the majority of respondent accessed AusPARs only when AusPARs on certain drug classes were published. This information was subsequently used to gain insight into the TGA's regulatory decision-making process, trends in the TGA's perspective on drug development programs, and to gain regulatory information on competitors and their data submitted to the TGA. AusPAR information was also used to keep current with new medicines and indications, as well as writing medicines information, training/teaching, and conducting research into prescription medicines. All three published documents - the AusPAR itself, Extract CER, and PI - were regularly accessed and considered useful by most readers.

Transparency – How useful are AusPARs

The vast majority of survey respondents said that AusPAR documents adequately served their purpose of providing transparency into the TGA's decision making process for prescription medicines, were useful to the person's needs, and that they would continue to access again AusPARs in the future. A smaller number of respondents accessed AusPAR pages only when a new AusPAR was published, presumably when they received an update via the AusPAR email notification list.^[3]

Suggestions for improvements

The TGA is currently considering the suggestions for the improvement of AusPAR documents. This includes including a plain English and more consumer-friendly summary along with more details of the rationale for the decision in the AusPAR. Rather than changing AusPAR format to address the issue raised regarding chronology, TGA has been, and will continue to be, open to the inclusion of footnotes in the AusPAR to inform readers if an issue raised in the evaluation was later resolved so that the reader does not have to go through the whole document to find the answer.

The TGA is currently implementing methods to improve the timing of AusPAR publications.

The TGA is also considering making improvements to the AusPAR pages on the TGA website. Improvements may include providing more detailed information on the landing page of individual AusPARs to help readers identify different applications for the same product, and classifying AusPARs according to distinctive disease classes treated.

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On this page: Question 3 data | Question 4 data | Question 5 data | Question 6 data | Question 7 data | Question 8 data | Question 9 data | Question 10 data

Question 3 data

Table 1: Which group best describes you?

Category	Total (n)
Academic	4
Consumer/Patient	3
Government	11
Health Care Professional	15
Medicines Regulator	4
Media	0
Pharmaceutical Industry	71

Question 4 data

Table 2: Which country do you reside in?

Category	Total (n)
Australia	95
Other - please specify	10

Question 5 data

Table 3: Which AusPAR document(s) do you mostly access?

Category	Total (n)
AusPAR	88
Extract from the Clinical Evaluation Report (CER)	59
Product Information (PI)	68

Question 6 data

Table 4: How often do you access AusPAR pages?

Category	Total (n)
Every time a new AusPAR is published	20
Only when AusPARs on drugs from certain classes are published (e.g. cardiovascular)	57
Rarely	28

Question 7 data

Table 5: What do you use the AusPAR information provided for?

Category	Total (n)
Academic research	3
Government related	12
Market research	21
Medical prescriber interest	5
Personal interest	11
Other – please specify	53

Question 8 data

Table 6: How well would you say the AusPAR documents serve their purpose of providing transparency of the TGA's decision process of prescription medicines?

Category	Total (n)
Very well	40
Well	41
Somewhat	21
Not at all	3

Question 9 data

Table 7: How useful are the AusPAR document(s) for your needs?

Category	Total (n)
Very useful	38
Useful	49
Somewhat useful	16
Not at all useful	2

Question 10 data

Table 8: How likely are you to access information contained in AusPAR document(s) in the future?

Category	Total (n)
Very likely	72
Likely	18
Somewhat likely	12
Unlikely	3