To provide a forum to evaluate, discuss and recommend methods and strategies for imaging in clinical trials to all stakeholders.
To provide a voice for the various stakeholders in imaging clinical trials to effectively influence and advance the field and to further the acceptance by the industry and regulatory bodies.
While members of the pharmacologic, biotechnology and medical device industries, contract research organizations, central imaging laboratories in addition to academicians, consultants, clinicians, radiologists and nuclear medicine physicians are considered obvious stakeholders this forum is open and welcomes the input from other groups including regulatory bodies and professional organizations. Any clinical trials that use imaging to inform therapeutic, diagnostic or safety endpoints are considered imaging clinical trials.
The group had its beginnings as the PhRMA biomarker working group in 2002. Given the interest and importance of imaging in the biomarker space the extended PhRMA Imaging Group (extended PIG) was formed and the inclusion of members from imaging vendors, imaging CROs, the National Institutes, regulatory agencies, professional organizations such as the RSNA, Key Opinion Leader and academicians were sought. The impetus for the group was the observation that a lack of harmonized and standardized processes was impacting the quality, cost, efficiency, and effectiveness of clinical trials that depended on medical imaging as primary or secondary endpoints. It was also noted that imaging professionals in the pharmaceutical industry did not yet have the critical mass required to meaningfully influence the field of medical imaging. The goal was to form alliances with larger stakeholders.
Amongst other activities over the years, the extended PIG has been critical:
In the development of a standardized format for imaging charters (now known as the DIA charter format)
In the support of the PhRMA PFS working group
The discussion of the draft Guidance for Industry, Standard for Clinical Trial with Imaging Endpoints (2011/2012)
The group chose to rename itself in January 2013 to Pharma Imaging Network for Therapeutics and Diagnostics (PINTAD).
PINTAD is currently chaired by the following members:
Fabien Ricard, MD
Director of Global Clinical Development and Medical Affairs
Senior Principal Statistician, Imaging
Former chairs inlude:
2002-2003 James McLeod, MD (then VP at Schering Plough)
2004-2007 Mostafa Analoui, PhD, MS (then Sr. Director at Pfizer)
2007-2011 David Mozley, MD (then Sr. Director at Merck & Co)
2011-2012 James Conklin, MD, MS (then Sr. VP of Medical & Scientific Affairs, ICON)
2013-2020 Annette Schmid, Ph.D. Chair (then Sr. Scientific Director Translational Research and Early Clinical Takeda Pharmaceutical Company)
Susanta Sarkar, Ph.D. Co-Chair (then President at CadenzaMed LLC and Adjunct Associate Professor, Dept. of Radiology University of Pennsylvania)
PINTAD has grown to include over 150 professionals across the imaging clinical trial industry from pharma- and biotechnology companies, imaging CROs, cooperative groups and institutions involved in the clinical trial research, Key Opinion Leaders and members affiliated with regulatory agencies.