Summary: Funding and costs of Xtandi (Enzalutamide) trial: NCT00974311

The request was partially successful.

Kavian Kulasabanathan

Dear The Royal Marsden NHS Foundation Trust,

Note that this request pertains specifically to The Royal Marsden Hospital.

Under the Freedom of Information Act 2000, please provide me with all of the following:

1) Details of all parties that have contributed funding to the trust in relation to the Xtandi (Enzalutamide) trial NCT00974311 being conducted at your site/s.

2) A list of all sites within your trust that Xtandi (Enzalutamide) trials have been conducted at.

3) Numbers of Xtandi (Enzalutamide) trial participants at each trial location, for the NCT00974311 trial.

4) Number of staff involved in conducting the trial at each trial location, listing their roles, for the trial, NCT00974311

5) What costs were incurred by the trust in order to conduct the Xtandi (Enzalutamide) trial, NCT00974311? If a document does not state the total budget or cost of a trial, but lists the actual or expected costs of any aspect of the trial, it would also be subject to this request. If a document states the yearly budget for a clinical trial, that would be pertinent as well.This includes per-patient costs in conducting the trial. The simplest response would be to provide the cost in GBP of either the budget for the trials or the actual outlays, and both if that is possible.

6) A breakdown of any funding received from internal and external sources in order to conduct the Xtandi (Enzalutamide) trial, NCT00974311. Please break funding down into i) funding from public (governmental) bodies, ii) private entities, and iii) philanthropies/charitable bodies. Please include the full name of the funding body. Please specify amounts in GBP. (Please provide this as an excel spreadsheet)

7) A record of all expenses incurred in conducting the Xtandi (Enzalutamide) trial, NCT00974311.
This may include: unit costs of test, fees to central laboratories, investigator fees, data management costs.

Format: please provide the reply to our request in electronic format, in the form of an Excel sheet where possible.

END OF FOI

Yours faithfully,

Kavian Kulasabanathan

Freedom of Information Complaints, The Royal Marsden NHS Foundation Trust

1 Attachment

Dear Kavian,

 

Thank you for your Freedom of Information request (our ref 5500)

 

We will aim to respond to your request within 20 working days. However, we
recognise the unprecedented challenges all are facing during the
coronavirus (COVID-19) situation. Staff and other resources are being
diverted away from their usual work including compliance or information
rights work. Due to this there may be delays to responding to FOI requests
while staff prioritise other areas or adapt their usual approach. We would
ask for people’s patience and understanding during this time.

 

 

Kind regards

 

 

Saimah Tahir

Corporate Governance Manager

The Royal Marsden NHS Foundation Trust

[1]www.royalmarsden.nhs.uk

 

 

 

 

References

Visible links
1. http://www.royalmarsden.nhs.uk/

Freedom of Information Complaints, The Royal Marsden NHS Foundation Trust

Dear Kavian

Thank you for your Freedom of Information request. Please find our response below.

1) Details of all parties that have contributed funding to the trust in relation to the Xtandi (Enzalutamide) trial NCT00974311 being conducted at your site/s.
Medivation Inc-USA and Astellas Pharma Inc and Pfizer

2) A list of all sites within your trust that Xtandi (Enzalutamide) trials have been conducted at.
The Royal Marsden Hospital (Sutton)

3) Numbers of Xtandi (Enzalutamide) trial participants at each trial location, for the NCT00974311 trial.
The Trust believes that for this question, section 43 (2) of the Freedom of Information Act 2000 is engaged; information is exempt under section 43 (2) if disclosure would result in the commercial interests of The Royal Marsden, or any other third party, being prejudiced by leaving it liable to have its prices undercut by competitors and challenged by existing and potential customers.

4) Number of staff involved in conducting the trial at each trial location, listing their roles, for the trial, NCT00974311
The study has been archived and so details of the staff involved, including their roles, is not accessible to us.

5) What costs were incurred by the trust in order to conduct the Xtandi (Enzalutamide) trial, NCT00974311?
It is not possible to determine the costs incurred by the Trust; this is not information that is gathered as part of our normal working practices.

If a document does not state the total budget or cost of a trial, but lists the actual or expected costs of any aspect of the trial, it would also be subject to this request. If a document states the yearly budget for a clinical trial, that would be pertinent as well.This includes per-patient costs in conducting the trial. The simplest response would be to provide the cost in GBP of either the budget for the trials or the actual outlays, and both if that is possible.

The Trust believes that for this question, section 43 (2) of the Freedom of Information Act 2000 is engaged; information is exempt under section 43 (2) if disclosure would result in the commercial interests of The Royal Marsden, or any other third party, being prejudiced by leaving it liable to have its prices undercut by competitors and challenged by existing and potential customers.

6) A breakdown of any funding received from internal and external sources in order to conduct the Xtandi (Enzalutamide) trial, NCT00974311. Please break funding down into i) funding from public (governmental) bodies, ii) private entities, and iii) philanthropies/charitable bodies. Please include the full name of the funding body. Please specify amounts in GBP. (Please provide this as an excel spreadsheet)

The Trust believes that for this question, section 43 (2) of the Freedom of Information Act 2000 is engaged; information is exempt under section 43 (2) if disclosure would result in the commercial interests of The Royal Marsden, or any other third party, being prejudiced by leaving it liable to have its prices undercut by competitors and challenged by existing and potential customers.

7) A record of all expenses incurred in conducting the Xtandi (Enzalutamide) trial, NCT00974311. This may include: unit costs of test, fees to central laboratories, investigator fees, data management costs.

The Trust believes that for this question, section 43 (2) of the Freedom of Information Act 2000 is engaged; information is exempt under section 43 (2) if disclosure would result in the commercial interests of The Royal Marsden, or any other third party, being prejudiced by leaving it liable to have its prices undercut by competitors and challenged by existing and potential customers.

If you are dissatisfied with this response and wish to appeal then please let me know by writing to:

Corporate Governance
The Royal Marsden
Fulham Road
London
SW3 6JJ

Or alternatively, you can email: [The Royal Marsden NHS Foundation Trust request email]

Any complaints will be dealt with through our Internal Review procedure. If you are still not satisfied following the Internal Review, you have a right to appeal to the Information Commissioner using the following contact details:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Telephone: 01625 545 700

Kind regards

Brinda Sittapah
Company Secretary
The Royal Marsden NHS Foundation Trust

www.royalmarsden.nhs.uk

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