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A continued FDA Concern about Imaging Based Drug Trials Society of Nuclear Medicine Albuquerque, Feb 1-2, 2009 PowerPoint Presentation
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A continued FDA Concern about Imaging Based Drug Trials Society of Nuclear Medicine Albuquerque, Feb 1-2, 2009. Orhan H Suleiman MS PhD, FAAPM Senior Science Policy Adviser Office of Oncology Drug Products Office of New Drugs. Good science!.

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A continued FDA Concern about Imaging Based Drug TrialsSociety of Nuclear MedicineAlbuquerque, Feb 1-2, 2009

Orhan H Suleiman MS PhD, FAAPM

Senior Science Policy Adviser

Office of Oncology Drug Products

Office of New Drugs

good science
Good science!

Good scientific principles are essential for good imaging based trials:

1. Standardize imaging equipment;

2. standardize imaging acquisition, processing, and display protocol;

  • standardize readers.
  • Know the uncertainties- 1%, 5%, 20%, 50%, 100%, ?
conduct quality control testing
Conduct Quality Control Testing

In order to assure that the images are being produced consistently over time you should…

Quality control test, with a phantom, before, during, and at the end of the trial, which should assure consistency in equipment performance! This includes the use of the same software and imaging technique.

history of imaging criteria
History of Imaging Criteria

World Health Organization (1970’s)

Response Evaluation Criteria in Solid Tumors – RECIST (2000, 2008)

3-dimensional volumetric analysis (current)

slide6

baseline

30 days

- 3.5 %

- 32 %

RECIST

Volume

RECIST vs. Volumetrics

Diameter = 17.7 mm

Volume = 886 mm3

Diameter = 17.1 mm

Volume = 525 mm3

Bensheng Zhao, MSKCC

calibrate human readers
“Calibrate” Human Readers

Train the qualified readers, prospectively!

Use standard images to “calibrate” readers, either physically together, or with a detailed protocol. This should minimize adjudication.

Protocol should specify data collection, viewing conditions, image scoring and other criteria.

in closing
In closing…

Quality control testing with appropriate test phantoms must be used on all imaging equipment used to generate clinical images during the trial.

Ultimately successful clinical trials depend on using good science for the entire trial (drug, equipment, image, analysis).