Principles of a TACT review

  • Quote...
  • "...[TACT] is a very valuable instrument to help clinicians and scientists to design sensible clinical trials in muscular dystrophy"

    Dr Emilio Clementi &
    Dr Grazia D'Angelo
    H Sacco University Hospital
    Milan Italy

TACT circulates a confidential report to the named investigator whose application has been reviewed. A non-confidential summary is also posted on the TREAT-NMD website. Other parties interested should contact the investigator directly for further information and/or to request a copy of the full TACT report.

All TACT reports are provided in pdf format on TACT letterhead. It is expected that investigators sharing the TACT report with other interested parties will circulate the original TACT report, unmodified. TACT reports should not be revised or altered when provided to third parties, as they will no longer accurately reflect the committee's discussions and recommendations.

Investigators may send interested parties additional information with the report, and it is expected that additional information is clearly highlighted to ensure the distinction is clear from the original TACT report.

TACT is not a funding organization but provides evaluation and recommendations which might facilitate development of a review into an application to a funding organization. The conduct of a TACT review is not an endorsement by TACT or by TREAT-NMD that a drug has any particular status from a regulatory or funding potential. The review is purely advisory and educational in its focus and does not assign any grading of the quality of the drug or planned programme.

 
01 Nov 2015