121IN - Can collaborative molecular screening platforms (CMSPs) support new forms of cancer clinical research? The example of the EORTC SPECTA programme

Date 29 September 2014
Event ESMO 2014
Session ESMO-ASCO: The evolution of the clinical trial landscape
Topics Clinical Research
Bioethics, Legal, and Economic Issues
Translational Research
Basic Scientific Principles
Basic Principles in the Management and Treatment (of cancer)
Presenter Denis Lacombe
Citation Annals of Oncology (2014) 25 (suppl_4): iv41-iv42. 10.1093/annonc/mdu317
Authors D.A. Lacombe
  • Headquarters, European Organisation for Research and Treatment of Cancer, 1200 - Brussels/BE

Abstract

Body

Abstract:

While there is a need for rapid access to more efficient treatments, drugs regulators require a comprehensive understanding of the risk-to-benefit ratio. The quantity and the quality of data that need to be handled are substantially increasing while the economic environment is more stringent. The challenges ahead of oncology include: optimizing clinician access to high quality genomic information, providing guidance for target assessment with new type of molecular guidelines, developing new approaches to market access and new health care models, long-term follow-up of patients, real life implementation, health technology assessments. To achieve such goals, new innovative forms of clinical research are needed. A solid understanding of biology will support robust confirmatory trials. Integrating new molecular entities in therapeutic strategies is today's challenge. New forms of clinical research and new methods for access to clinical trials based on clinically annotated biological data and longitudinal follow up of patients to understand patterns of resistance will be needed. CMSPs sorting patients according to molecular features for treatment decision are proposed to fill the gap between knowledge and implementation of personalized treatments. The EORTC has set up CMSPs as a new approach to tackle this issue at the European level. With primary mission to structure patient access to international molecular based clinical trials, SPECTA (Screening Patients for efficient Clinical Trial Access) is an advanced model of CMSP. Building on the EORTC multidisciplinary network, validated clinical trial infrastructure and regulatory compliant tools and procedures, SPECTA is a unique pan European program optimizing the expertise of all stakeholders from patients to payers and combining efforts alongside cost-sharing models for efficient patient selection. With currently 5 platforms addressing colo-rectal, lung, brain and prostate cancer as well as melanoma, EORTC demonstrates the international, legal and operational feasibility of such platforms. Not only efficient patient selection and sorting depending on relevant molecular alterations happens through a single portal but also optimizing and rationalising expensive screening programs is being made possible through new models of partnerships.

Disclosure:

The author has declared no conflicts of interest.