| It is nearly 20 years since the first commercial imaging core
laboratory was founded. Today, there are numerous commercial
imaging core laboratories, numerous international imaging biomarker
meetings and regulatory guidance documents to support the use of
imaging in drug development. Many academic, government and
commercial entities have contributed to the growth of this approach,
which has become a mainstream tool for the development of
numerous therapeutic drugs.
Medical imaging endpoints are accepted in many clinical
trials, and when included in the study design, the FDA requires
the implementation of a central, independent image review process.
The proliferation of medical imaging endpoints and the resulting
management, analysis and submission of medical imaging data has
fostered the healthy growth of the medical imaging core lab industry,
both for commercial and academic labs.
The increase in the number of labs and studies for which they
provide services led to a somewhat varied set of documentation and
implementation of various technology methods for what is a largely
consistent undertaking. Pharmaceutical trial sponsors and the FDA
initiated the desire for standardisation in these trials, and DIA has
provided the leadership needed to obtain collaboration from all
affected parties. |
