Sponsor experience survey – sponsors who have not opened a tele-trial

We are interested in your experience as a sponsor (either as a trial group or commercial sponsor) who has not opened a tele-trial but who has actively considered implementing or are intending to implement a tele-trial. This information will be used to identify concerns sponsors may have about the Tele-Trial Model and identify the barriers and enablers for tele-trials within Australia to inform the ongoing implementation of the Tele-Trial Model in Australia. This information will also be used in the final project report for the COSA project to Pilot the Implementation of the Tele-Trial Model.

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* 1. Your name, title and role

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* 2. Company/group name

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* 3. Type of clinical trial sponsor

Commercial – drug, device, other

Academic – interventional, non-interventional, other

Other (please specify)

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* 4. Study type conducted (select all that apply)

Interventional

Non-interventional

Drug

Device

Other (please comment)

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* 5. For intervention studies what phase studies do you conduct? (Select all that apply)

Early development – Phase 1-1b

Late development – Phase 2-3

Other (please comment)

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* 6. Experience with conducting trials in Australia in past 5 years

Conducted a total of 1 to 10 trials

Conducted a total of 10 to 20 trials

Conducted a total of 20+ trials

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* 7. The majority of studies (one or more sites) opened in Australia are:

Local studies conducted within Australia or within ANZ network

Global multicentre studies with sites within ANZ

Single site studies

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* 8. Studies in Australia are run through:

Cooperative trial groups

Global CROs

Local CROs

Our own company resources

Other (please specify)

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* 9. Average clinical trial sample size?

Less than 100 patients

More than 100 patients

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* 10. Average number of sites engaged within Australia for phase 2 and phase 3 trials

1 to 5

6 to 10

More than 10

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* 11. Average number of patients recruited within Australia for a clinical trial

1 to 10

10 to 50

50 to 100

More than 100

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* 12. What category of study would you consider for implementation using the Tele-Trial Model (select all that apply)

Study with registrational intent (likely randomised, phase 2-3)

Observational or non-interventional or epidemiological study

Study that does not have complex requirements eg PK sampling, in hospital monitoring, etc

Post marketing / Real World Evidence / QoL or PRO studies

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* 13. Have you ever opened a tele-trial? If yes, please complete this survey

Yes

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* 14. How many clinical trial protocols have you identified as suitable to implement as tele-trials?

1 to 2

3 to 5

More than 5

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* 15. If you answered ‘0’ to Q14 what is the reason for this? Please comment

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* 16. What are your main concerns about opening a tele-trial? (Select all that apply)

I am not familiar with the Tele-Trial Model

Developing the internal processes necessary to implement tele-trials

Contracting with satellite sites

Satellite site fees

Monitoring costs

Supervision of satellites sites

Managing investigational product (supply chain)

IP shipment / labelling / storage at satellite sites

Complexity of protocols, need for intense monitoring / observations / testing

PK studies and sample handling and storage

Pathology and imaging needs and cost to travel if required

Studies where hospitalisation or ICU back up may be required

Source document management (including version controls – protocol, consent, CRFs)

Data quality

Indemnity / insurance

Patient safety

Other (please comment)

Sponsor experience survey – sponsors who have not opened a tele-trial

Question Title

* 1. Your name, title and role

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* 2. Company/group name

Question Title

* 3. Type of clinical trial sponsor

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* 4. Study type conducted (select all that apply)

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* 5. For intervention studies what phase studies do you conduct? (Select all that apply)

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* 6. Experience with conducting trials in Australia in past 5 years

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* 7. The majority of studies (one or more sites) opened in Australia are:

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* 8. Studies in Australia are run through:

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* 9. Average clinical trial sample size?

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* 10. Average number of sites engaged within Australia for phase 2 and phase 3 trials

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* 11. Average number of patients recruited within Australia for a clinical trial

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* 12. What category of study would you consider for implementation using the Tele-Trial Model (select all that apply)

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* 13. Have you ever opened a tele-trial? If yes, please complete this survey

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* 14. How many clinical trial protocols have you identified as suitable to implement as tele-trials?

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* 15. If you answered ‘0’ to Q14 what is the reason for this? Please comment

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* 16. What are your main concerns about opening a tele-trial? (Select all that apply)

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* 17. How can these concerns be addressed? Is there anything that could be done at a system level that may assist?

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* 18. Do you plan to initiate a tele-trial in the future? Please comment