Autologous Chondrocyte Transplantation / Implantation Versus Existing treatments


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FUNDING

  • ACTIVE is funded by the Medical Research Council (MRC)
  • The funds are administered by Keele University
  • The Department of Health (DoH) are funding approximately 90% of the excess treatment costs, i.e. 90% of the estimated difference between the standard surgical procedures used in one arm of the trial and the more expensive ACI treatment used in the other arm of the trial
  • The Collaborator Agreement must be signed by your Trust and Keele University before funding will be paid
  • The funding is summarised in Annex C of the Collaborator Agreement.

What funding should my hospital get?

  • £2655 per patient treated in the trial - from DoH for excess treatment costs (UK only)
  • £100 per patient participating in the trial - to cover coordinator's time
  • £35 per patient assessment - to cover independent assessor's time
  • Each individual NHS Trust can apply for NHS Service Support Costs from the UKCRN..

How can my hospital claim excess treatment costs?

The Trial Manager will send a letter to the appropriate person in your Trust after each quarter (beginning 1st April) confirming which patients were treated in the trial* in the previous 3 months and the total costs to be claimed. Your Trust can then send this letter with their invoice to the Department of Health.

*Completion of the Treatment Record Form is needed to confirm treatment took please - please ensure copies are sent to the Trial Manager immediately after treatment.

Remember: £2655 is due for every patient in the trial not just those in the ACI arm.

How can my hospital claim funding for a local study co-ordinator?

Funding for your local study co-ordinator is paid to your hospital on a per-patient basis. After each quarter the Trial Manager will send a letter to your Trust confirming how many patients actually entered the trial and the amount of funding that can be claimed (£100 per patient). Your Trust can then send their invoice to the Trial Office.

For information on the study co-ordinator's duties click on: Coordinators

How can my hospital claim funding for an assessor?

Departmentally

Most independent assessors already work in the Physiotherapy Department of your hospital. Due to the irregular/infrequent working times of the assessor some Physiotherapy Departments will release the assessor from normal duties so that she/he can do the assessments as and when required. After each quarter the Trial Manager will send a letter to your Physiotherapy Department confirming how many assessments were done and the total costs to be claimed. Your Physiotherapy Department can then send this letter with their invoice to Keele University.

Individually

Some assessors have agreed to do the assessments on a self-employed basis. After each quarter the Trial Manager will send a letter to the assessor confirming how many assessments were done and the total costs to be claimed. Your assessor can then send this letter with her/his invoice to Keele University.

Up to 2 hours should be allowed for the assessor to carry out all the duties required for each assessment. For more information click on: Assessors

How can my hospital claim Service Support Costs?

Service Support Costs include the overhead costs incurred by NHS clinics where patients are participating in ACTIVE. The NHS R&D budget will meet Service Support Costs incurred as a result of participation in MRC funded trials. The DoH accepted Service Support Costs in ACTIVE at the following rates:

  1. Registration and obtaining consent - £45.50 per patient formally registered with the Trial Office. This is to cover the overhead clinic running costs. Please note this is available in addition to the funding already described above for the local coordinator
  2. Serology (for HIV, hepatitis B, C, syphilis and HTLV I & 2) - £80 per patient in the standard arm of the trial for whom serology tests would not normally be necessary outside of the trial.
  3. Follow-up out-patient clinic visits - £65 for each patient at each hospital visit for the 6 months, 3, 5, and 10 year follow-up assessments, i.e. hospital visits that patients wouldn't normally need to attend outside of the trial.

Please note: ACTIVE is on the UKCRN portfolio and as of 2008 these costs are to be claimed through the UKCRN.

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ACTIVE is being carried out by the Robert Jones & Agnes Hunt Orthopaedic & District Hospital NHS Trust in collaboration with the University of Birmingham Clinical Trials Unit and Health Economics Facility. The trial is funded by the Medical Research Council and administrated by Keele University.