Clinical Trials Connect Patient Recruitment Survey Australia 2012 - 2013

Foreword Australia’s global position as a desirable destination to conduct research has been under threat for some time now. Delays relating to patient recruitment is just one of the factors effecting Australia’s profile as an attractive location. The clinical trial action group (CTAG) report released in March 2011 indicated that 90% of clinical trials in Australia experience recruitment delays. Establishing some benchmarks around recruitment rates, cost and capacity is important to maintaining global competitiveness.

CTC’s “Patient Recruitment Survey Australia” is an inaugural inquiry into the patient recruitment trends and habits of researchers in Australia. The survey follows on from CTC’s paper on the “Statistical analysis of the market potential for a patient recruitment service within Australia”, May 2011. The paper was funded by the Federal Government Department of Innovation Industry Science and Research (DIISR) and the results were presented at the CTC Industry information series held in Melbourne and Sydney. CTC employed the services of statistical consultant Steve Vander Hoorn from Melbourne University’s Statistical Consulting Centre to perform the review. Part of the report included an analysis of average recruitment rates per week per centre in Australia - this was based on a random sample of 40 trials and results revealed that 78% of trials recruited less than one participant a week. The data was compared to CTC recruitment rates and capacity* which revealed an average as high as three a week and never less than one. Cost per subject was also analysed and CTC’s average range was as low as $50.00 and never over $600.00. These costs were compared to case studies of trials utilising traditional advertising methods, and to the costs of initiating more sites per trial (site intensity) in an effort to meet participant targets. These figures ranged from $1,600 to $30,000 plus, as a cost per subject. Included in the report was an additional metric looking at the percentage of times the recruitment target requested by the client was met, and 60% of the time CTC was able to meet the client order 100%. *Based on a sample of the last five trials CTC had recruited for at the time (2011)

CTC | Patient Recruitment Survey Australia 2014

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Foreword Since the release of the paper in 2011, CTC has been keen to continue to build on the outcomes of the knowledge gained from this initiative. The current survey was developed to continue to assist the identification of current trends, resource allocation and areas for reform so that stakeholders can work towards supporting an improved patient recruitment environment. The survey was distributed by Medicines Australia to 54 companies including 34 pharmaceutical companies, 11 medical biotechnology companies and 9 contract research organisations, on the 8th of July 2013 and received a 22% response rate.

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Summary

Summary The survey has provided a good indication around current recruitment methods and spending habits which is important to future reform and developing more cost efficient participant recruitment processes. There is a clear need for change as current techniques being employed and relied upon to source participants for trials are costly and needlessly protracting the process. The survey outcomes have revealed that there are recruitment avenues that are underutilised or unused, and there is a lack of clarity on whose responsibility it is to implement a recruitment plan. Participant recruitment is an area that requires more focused and specialised attention. Clearer strategies around the accrual process need to be implemented earlier and better budgets need to be considered from the outset more consistently.

CTC is keen to pave the way forward in helping researchers achieve more cost effective methods and outcomes and to help people connect to valuable research opportunities.

CTC is keen to pave the way forward in helping researchers achieve more cost effective methods and outcomes and to help people connect to valuable research opportunities. We will continue to evaluate industry practices and provide feedback in order to establish better methods for connecting researchers with eligible participants.

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About Clinical Trials Connect (CTC) Clinical Trials Connect (CTC) is a privately owned online participant recruitment company established in 2008 by Division 1 Registered Nurses Mary Pym and Christine Veljanoski. CTC provides a free service to the public and is funded by researchers wishing to list their trial(s) on the website. CTC has developed a user-friendly web portal to help match members of the Australian community to research opportunities, and deliver recruitment solutions to researchers. People are able to register their interest to participate in trials on the website in one of two ways, either as a patient with a medical condition or as a healthy volunteer.

The evolution in today’s technology offers a variety of opportunities for patient recruitment and CTC is harnessing modern methods of communication to facilitate the patient accrual process. CTC’s priority is to support the advancement of medical science today so that all Australians can look forward to a healthier tomorrow. We have three main goals underpinning this mission:

CTC | Patient Recruitment Survey Australia 2014

Researchers Help unite researchers with potential volunteers

Patients Help unite community to research. Ensure all citizens maintain access to developing medicines/new modes of treatment

Health Practitioners Provide a referral pathway to trials for health care professionals and options to patients where current treatment alternatives are not effective

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Acknowledgments CTC would like to acknowledge Steve Vander Hoorn (Statistical Consulting Centre, University of Melbourne) and Associate Professor Peter Foley (Dermatologist, Director of Research, The Skin and Cancer Foundation Inc, Head Dermatology Research Unit, ST Vincent’s Hospital Melbourne) for their valuable input and guidance in the development of the survey. We would also like to extend sincere thanks to Medicines Australia for their support in the distribution of this survey.

Steve Vander Hoorn

Associate Professor Peter Foley

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Results

Question 1 How many clinical trials did your company conduct globally? Please answer numerically. This is a free text Question. ( n=12) The total number of trials conducted globally in the financial year July 2012-June 2013 was 2680. The average equaling 223. One respondent answered that their company conducted 1651 trials globally in the last financial year which was unusually high. Excluding this number from the total would reduce the average to approximately 100.

Question 2 How many clinical trials did your company conduct that included Australian sites? Please answer numerically. (n=12)

of new clinical trials which is encouraging, however, it is still early to determine that Australia’s global position as an attractive location to conduct research has been restored. The TGA half yearly performance report shows fewer number of trials in the first half figures of 2013 (326) compared to the same time in 2012 (343). The results in the CTC survey to these three questions show that overall only 14% of studies conducted globally by our respondents included Australian sites, with even less in New Zealand (5%). Even though Australia only holds around 0.3% of the world population it produces around 3% of global medical research (Source: Pharmaceutical Industry Profile, Australian Government Department of Industry Website).

The total number of trials conducted in the financial year July 2012-June 2013 that included Australian sites was 382. The average equaling 32.

Question 3 How many clinical trials did your company conduct that included New Zealand sites? Please answer numerically. (n=12) The total number of trials conducted in the financial year July 2012-June 2013 that included New Zealand sites was 129. The average equaling 11. According to TGA performance reports clinical trial activity in Australia saw a peak in 2007, however since then Australia experienced a period of three straight years of decline. 2011 and 2012 saw a steady 11.78% increase in the number

CTC | Patient Recruitment Survey Australia 2014

This is a significant contribution, however, there is potential for more work on our shores and it is important we maintain current activity.

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Question 4 Of those trials with sites in Australia please rank in order the most common to least common phase conducted. CTC survey results to this question revealed that Phase 1 (54%) was the most commonly conducted study and 63% indicated that Phase II was the second most commonly conducted trial. Phase III studies were ranked equally at (45%) for being the first and third most common studies conducted. Ninety per cent of respondents indicated that Phase IV trials were the least common study in Australia. The results to this question may be indicative of Australia’s difficulty in meeting the larger numbers typically required for Phase III studies. Phase I and II trials usually recruit smaller numbers of participants; between 20-80 volunteers (Phase I) and between 100-300 (Phase II) compared to 1000-3000 people (Phase III). A survey on “The Value of Industry Sponsored Clinical Trials in Australia” conducted by the NSW Clinical Trials Business Development Centre, on behalf of the Pharmaceutical Industry Council (PIC), indicated in its survey that the majority of trials being conducted in Australia were Phase III (46%) and that Phase I and II trials made up a further 18.1% of trials. It was also noted that Phase III require the largest number of patients and were therefore more sensitive to cost and more vulnerable to competition from emerging markets.

100% 80% 60% 40% 20% 0%

Phase 1

1

Phase 2

2

3

4

N/A

Phase 3 Answered: 11

Phase 4 Skipped: 1

It was also noted in the PIC R&D task-force Global Competitiveness Benchmarking Survey (2009), that companies predicted an increase in the number of Phase I and II clinical trials (which are less cost sensitive) and a decrease in Phase III (Value of Industry Sponsored Clinical Trials in Australia, Pg 22-23), which is reflective of the results in this CTC survey question.

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Question 5 Overall, how often did your company meet recruitment deadlines? (Please answer according to original deadline set) The Clinical Trial Action Group report released in 2011 revealed that 90% of clinical trials in Australia experience recruitment delays. The Centre for Information and study on clinical research participation (CISCRP) also state on their website that it is estimated for every day a drug is delayed from market sponsors may loose up to $8 million (Beasley, 2008).

CTC felt it was important to obtain a measure around success rates in this area so that we can monitor future progress. Survey results revealed that the majority of respondents (37.5%) only met recruitment targets around 50-79% of the time in the last financial year and only a quarter of respondents met targets either 80-99% or 100% of the time.

CTC | Patient Recruitment Survey Australia 2014

Answered: 8 Skipped: 4

100% 80% 60% 40% 20% 0%

100% of the time

80%-99%

50%-79%

Less then 50%

Never

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Question 6 On average what do you estimate your company spent on patient recruitment per enrolled subject for trials conducted in: CTC encourages researchers to take a proactive approach to recruitment; however, traditionally sponsors are very reactive in their approach to the participant accrual process, which can often result in costly advertising campaigns. CTC asked this question to establish a benchmark around average cost per enrolled subject. The results revealed that the majority of sponsors are spending greater than $10,000 AUD per enrolled subject in Australia (71.4%) and globally (43%).

Australia

Answered: 7

Skipped: 5

100% 80% 60% 40% 20%

71.4%

43%

0%

Average amount spent per enrolled patient

50 AUD

100-500 AUD

3,000-4,000 AUD

500-1,000 AUD

4,000-5,000 AUD

1,000-2,000 AUD

5,000-10,000 AUD

2,000-3,000 AUD

Greater than $10,000 AUD

Non applicable

In New Zealand an average of $5-10 thousand AUD was spent per enrolled subject. These figures are consistent with the high costs per enrolled subject identified in the 2011 report and are a further indicator that spending habits in this area require urgent review.

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Question 6 continued On average what do you estimate your company spent on patient recruitment per enrolled subject for trials conducted in:

New Zealand

Answered: 7

Globally

Skipped: 5

100%

100%

80%

80%

60%

60%

40%

40%

20%

20% 0%

0%

100-500 AUD

3,000-4,000 AUD

500-1,000 AUD

4,000-5,000 AUD

1,000-2,000 AUD

5,000-10,000 AUD

Non applicable

CTC | Patient Recruitment Survey Australia 2014

2,000-3,000 AUD

Greater than $10,000 AUD

Skipped: 5

Average amount spent per enrolled patient

Average amount spent per enrolled patient

50 AUD

Answered: 7

50 AUD

100-500 AUD

3,000-4,000 AUD

500-1,000 AUD

4,000-5,000 AUD

1,000-2,000 AUD

5,000-10,000 AUD

2,000-3,000 AUD

Greater than $10,000 AUD

Non applicable

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Question 7 What were the therapeutic areas most commonly investigated by your company? Please select all that apply The therapeutic areas most commonly investigated in trials conducted in Australia, globally and NZ were:

Answered: 7

Skipped: 5

Alternative and complimentary... Anesthesiology Cardiovascular Cosmetic Medicine Dermatology Drug Rehabilitation Ear Eye Haematology Infection Inflammatory and Immune System

Cardiovascular

Haematology

Oncology

Injuries and Accidents Human Genetics and Inherited

These areas were closely followed by Inflammatory and Immune system disorders, metabolic and endocrine and neurological and infection.

Mental Health Metabolic and Endocrine Musculoskeletal Neurological Oncology Oral and Gastrointestinal Physical ie/Rehabilitation Public Health Renal and Urogenital Reproductive Health and Childbirth Respiratory Surgery Stroke Other

0

3 Australia

CTC | Patient Recruitment Survey Australia 2014

6 Globally

9

12

15

New Zealand

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Question 8 Please indicate from the list below the most common setting used for your trial. Please rank in order from most common to least common. The clinical trial setting may impact on recruitment strategies. The trial setting can present limitations around advertising options but may also provide advantages that should be recognised and harnessed. 100% of respondents stated that Hospitals are the most common setting for clinical trials in the last financial year and that Universities are the least common setting. Clinical trial activity within hospitals is currently not well integrated with other services of an institution. Clinical trials are often misunderstood and their place within the healthcare system is often seen as a peripheral service. With the emerging e-Health system and already established Personally Controlled Electronic Health Records (PCEHR) there is great potential to leverage from this technology to facilitate participant recruitment into trials. CTC is keen to see that e-Health incorporates the needs of the clinical research community into the national e-Health framework, and in October 2012 CTC was invited to participate in a workshop held by the Pharmaceuticals Industry Council (PIC). The workshop was funded by the Department of Industry, Innovation, Science, Research and Tertiary Education, and with the support of the Department of Health & Ageing, and the National e-Health Transition Authority.

One of the recommendations that came out of the workshop was that the Australian Government establish an interdisciplinary stakeholder working group who’s members were drawn from those who attended the workshop, so that some of the ideas proposed could be further explored/developed into a set of final strategies. We are hopeful that there will be progress in 2014.

Answered: 7 100% 80% 60% 40% 20% 0%

Hospitals

1

CTC | Patient Recruitment Survey Australia 2014

Skipped: 5

2

Private Practice/Clinic

Universities

3

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Question 9 Overall, how many of the sites initiated per trial included centers outside metropolitan areas? 57% of respondents claimed that 11-20% of sites initiated per trial included centres outside metropolitan areas. This is encouraging as it is important that research is accessible to people living in regional, rural and remote Australia. CTC’s use of digital media communication strategies increases the opportunity for these communities to learn about opportunities that may be suitable to them.

Answered: 7

Skipped: 5

100% 80% 60% 40% 20% 0%

CTC | Patient Recruitment Survey Australia 2014

Less 10%

11-20%

21-50%

51-75%

76-100%

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Question 10 Does your company routinely plan and implement a recruitment strategy prior to initiating a clinical trial? It was encouraging to see that no-one answered “never” to this question and that 71.4% of respondents answered that a recruitment plan is “Always” developed prior to initiating a clinical trial.

Answered: 7

Skipped: 5

100%

80%

60%

Please note: For the purpose of this survey a ‘Recruitment Plan’ is defined as a comprehensive central working document that describes the patient accrual process. The plan should include a clearly defined purpose and goal, a recruitment strategy and intervention, and an evaluable outcome/ objective with a specified time-frame.

CTC | Patient Recruitment Survey Australia 2014

40%

20%

0% Always

Most of the time

Some of the time

Never

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Question 11 Please state whose responsibility it is within your company to develop a patient recruitment plan. As this was a free text question the following responses were received:

1.

2.

3.

4.

5.

Global Trial Manager

Study Lead

Study-Global study Manager, Lead Country- Country Study Manager, Site- Clinical Trial Monitor

PM

Clinical

6. CRA’steam effort

7. Clinical

It is unclear in this question who the ‘PM’ is and who ‘Clinical’ is/are. It could be assumed that the respondents are referring to the site staff who are traditionally responsible for advertising and recruitment. Overall it seems that the assignment of the role to participant recruitment is variable and not clearly defined or consistent.

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Question 12 Does your company routinely allocate an advertising budget to each clinical trial at the beginning of every study? An overwhelming 84% of respondents indicated that an advertising budget is allocated to each clinical trial only ‘some of the time’. 16% stated that it is never allocated at the beginning of a study. It is interesting that the results of Q10 indicate that a recruitment plan is always conducted but that an advertising budget only forms part of the plan “some of the time”.

Answered: 6

Skipped: 6

100% 80% 60% 40% 20%

84% Some of the time

0%

Always

Most of the time

Some of the time

Never

16% Never

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Question 13 Is the advertising budget determined by: Answered: 6

Skipped: 6

100%

50%

80% 60% 40%

of respondents indicated that advertising budgets were mainly determined by Global Headquarters. Many sponsors’ global headquarters are based overseas and the requirement to follow this pathway for approval can present problems and delays in obtaining consent for advertising plans particularly as there may be a lack of understanding for the local environment.

CTC | Patient Recruitment Survey Australia 2014

20% 0%

Global Headquarters

Local Headquarters

Not Applicable

Other

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Question 14 What tools does your company commonly rely upon to support participation recruitment? Please tick all that apply from the most common to least common. The results in this graph clearly show that 100% of respondents number 1 tool for recruitment is the Investigator/site database, followed by advertising and referrals as an equal second or third option (50%).

Databases can be an effective recruitment tool, however many Investigators tend to innocently overestimate the number of participants they think they can enroll into a study simply because they may have access to a large database of people that meet the diagnostic criteria. However, meeting the diagnostic criteria for a study does not always mean that volunteers will meet the protocol criteria. Databases also require constant replenishing as people’s circumstances change. Occasionally people may spontaneously recover, they may die, develop co-morbidities or commence concomitant medications that are prohibited in the study protocol. Work schedules and any planned holidays may also need to be taken into consideration, as all of these factors can influence a person’s eligibility and ability to commit.

Answered: 6

Skipped: 6

100% 80% 60% 40% 20% 0%

Investigator/ site database

1

Advertising

2

Referrals

3

CTC advocates a proactive approach to recruitment always for these reasons, and no tool should be singularly relied upon.

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Question 15 When advertising what is the most common form of media used? 66% of respondents indicated that Print advertising is the most common form of advertising utilised. CTC’s experience with sites is consistent with the results received in this question. Traditionally sponsors allocate an advertising budget to each trial site involved in a study and rely upon the discretion of the study site staff for advertising and marketing arrangements who have no qualified media experience. Print advertising tends to be the most common choice of media placement, as busy staff do not always have time to investigate other communication options.

The emergence of new technologies in the digital space has opened up more cost effective solutions to raising awareness, and CTC is embracing these mediums.

Answered: 6

100% 80% 60% 40% 20% 0%

CTC | Patient Recruitment Survey Australia 2014

Skipped: 6

Print Advertising

Social Media

TV

Radio

Billboards

Not Applicable

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Question 16 Which advertising methods prove to be most effective? Please select the most effective tool in each category. The results in this question are also reflective of what CTC anticipated the outcome would be for most effective method in each category. In the Print advertising category 66% stated that the local paper was the most effective tool. This may be related to that fact that for many sites it is the only method used externally due to a lack of knowledge on other advertising options, or that Print is the only seemingly affordable choice. This is confirmed with the results received in the other categories. Social Media category showed that 83% of respondents have never used this medium. 83% also stated they had never used TV, 50% had never used Radio and 100% of respondents had never explored Billboards as an option.

Print

80% 60% 40% 20%

Advertising Method Local Paper Letterbox drop

83%

CTC | Patient Recruitment Survey Australia 2014

Skipped: 6

100%

0%

83%

Answered: 6

Commuter paper Flyers/ Posters

Mainstream paper Other

Newsletters

Never Used

50%

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Question 16 continued Which advertising methods prove to be most effective? Please select the most effective tool in each category.

Social Media

Television

100%

100%

80%

80%

60%

60%

40%

40%

20%

20%

0%

Advertising Method Facebook Ads Twitter

Commuter paper

Banner Ads

Never Used

0%

Advertising Method Please specify in the ‘other’ box. Please comment on station, times etc Never Used

No comments were provided.

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Question 16 continued Which advertising methods prove to be most effective? Please select the most effective tool in each category.

Radio

Billboards

100%

100%

80%

80%

60%

60%

40%

40%

20%

20%

0%

0%

Advertising Method AM Radio

FM Radio

Talk-back radio

CTC | Patient Recruitment Survey Australia 2014

Never Used

Advertising Method Freeways

Commuter stops (bus stops, train stations)

Never Used

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Question 17 Have you ever conducted a central recruitment campaign using a participant recruitment company or external service provider? The results in this question were equally divided into 50% indicating ‘yes’ they had used a recruitment campaign provider and 50% indicating they had not.

Answered: 6

Skipped: 6

100%

80%

60%

50% YES

40%

50% NO

CTC | Patient Recruitment Survey Australia 2014

20%

0%

Yes

No

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Question 18 If ‘no’ please explain why? No comments were received by those that had indicated they had not used a recruitment campaign provider.

Question 19 Which company(s) did you use? No detail provided.

Question 20 Did you find the service to be an effective method for facilitating patient recruitment? Answered: 3

Skipped: 9

Yes

No

0%

20%

40%

60%

CTC | Patient Recruitment Survey Australia 2014

80%

100%

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Question 21

Question 23

If ‘no’ please explain why.

Please comment on what you think would help facilitate patient recruitment in Australia. This was a free text question and the following feedback was received from respondents:

No comments were received by those who answered no to this question, but 33% of respondents stated that it was not effective.

Question 22 If ‘yes’ please explain why and highlight the most useful features of the service. 66% of respondents indicated that they found the recruitment company provider services to be successful, but did not elaborate on what the useful features of this service were.

CTC | Patient Recruitment Survey Australia 2014

•

“Greater personal involvement by the PI in the process”

•

“I believe in the areas we work in, we recruit really well”

•

“General promotion of clinical trials and general processes. Adoption of social media for patient recruitment and retention. Active patient referral between public and private. Dedicated resource at the site during recruitment. Accurate databases on disease area hotspots and therapeutic landscaping”

•

“Lower cost, conduct governance in parallel”

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