The Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC) was founded in February 2003
by Dr. Lia Gore at the University of Colorado Cancer Center and Dr. Tanya Trippett at Memorial Sloan-Kettering Cancer Center.
POETIC is composed of ten large academic medical centers in North America with a major emphasis on comprehensive
cancer care and research that provide the collaborative and research strength needed to complete intensive phase
I and II studies. Each of the institutions is uniquely suited to complete early studies in the pediatric and
POETIC's assets include membership in NCI-designated Comprehensive Cancer Centers, on-site NIH-funded pediatric
and/or general clinical translational research centers (CTRCs/CTSAs), and active collaborations with developmental
therapeutics programs for adults at a majority of its member institutions. The availability of strong basic science
and translational research programs at the institutions allows focus on the development and evaluation of new
therapeutic strategies for patients with cancer and related disorders.
POETIC's pediatric oncology studies focus on the biologic basis for anti-cancer therapy, and in particular, attempt to explore and
evaluate new agents and novel combinations of therapies early in clinical development.
What is POETIC's Mission?
POETIC's mission is to promote
the early clinical development of promising therapies for the treatment of children, adolescents and young adults
with cancer and related disorders.
Why was POETIC founded?
Investigators identified a need to develop intensive, biologically driven Phase I clinical studies in pediatric oncology
with two goals in mind:
- To simultaneously offer patients new and different options for treatment; and
- To rigorously evaluate novel agents in order to identify their most appropriate use in cancer treatment.
The decision to pursue development of a pediatric consortium was additionally fueled to address a need for early
clinical studies at each of the respective comprehensive cancer centers.
POETIC was developed to complement work being done in the Children's Oncology Group (COG) Phase I Consortium. Given the pace of drug development,
and the multitude of new drugs being tested, careful and complementary studies are critical for the advancement of cancer treatment.
What is the Vision of POETIC for future pediatric cancer treatment?
- To design and conduct early clinical trials with a primary emphasis on rational, biologically based drug development.
- To incorporate biologic correlative studies which facilitate the translation between basic science and clinical research.
- To increase the access to and availability of new agents to pediatric cancer patients.
- To identify and evaluate new agents and novel therapeutic strategies that will promote and improve quality of life for patients and families.
- To encourage inclusion of promising agents in larger scale clinical trials.
POETIC Organizational Structure
POETIC Data and Coordinating Center (DCC)
The POETIC Data and Coordinating Center (DCC), located at Memorial Sloan-Kettering Cancer Center (MSKCC),
is responsible for the management of project compliance, data collection, abstraction and entry, data reporting,
management of regulatory monitoring, problems and prioritization.
A central responsibility of the POETIC DCC is to ensure the protection of children as vulnerable subjects enrolled
on research studies from potential risk due to treatment with an experimental agent. This function is achieved by
frequent review, constant oversight, and input from third-party objective advisors. The study (steering) committee
consisting of the Protocol Chair, local Principal Investigators, research staff, and biostatistician (as needed),
who meet in conference call on a weekly basis to critically review the scientific progress of the clinical trial.
Prospective monitoring is conducted by the Protocol Chair/PI, Institutional Review Board, Clinical Research
Coordinator (CRC), and Data and Safety and Monitoring Committee from the POETIC Data and Coordinating Center
from the start of the study.
POETIC Contract and Budgeting Center
The functions of clinical trial contract and budget development and negotiation are handled at the Contract
and Budgeting Center housed at Children's Hospital Colorado. Streamlined negotiations with central
contracting and budgeting are one of the reasons that POETIC studies can open quickly. Under the consortium
agreement, all member institutions agree to abide by common principles of clinical trial conduct, intellectual
property, and publications. Similarly, by agreeing to a common budget, the member institutions save valuable
time and resources in avoiding individual negotiations for the conduct of clinical trials. This unified and
comprehensive approach to this aspect of protocol development has repeatedly proven to provide more accurate
and complete service for all parties involved in the development of these early phase clinical trials.
Strengths of POETIC
- Scientific resources
- Clinical research resources
- Data management resources
- Large patient population
- Geographic diversity
- Ethnic diversity
- Completion of studies in 2 year window
- Streamlined protocol review and management system
- Streamlined budgeting and contracting process