This was the title of a fascinating article I saw on Twitter a few minutes ago, courtesy of the American Association of Cancer Research (AACR). They are providing access to the paper free of charge to the public using this link. If you are on Twitter and interested in cancer related research, do follow them and keep track of the hot news items as they share quite a few important articles on translational research. Of all the medical associations I've come across in social media, they are also very helpful and responsive to enquiries.
So, what of the Consensus Report? Well, it's a collaborative effort from the AACR, FDA and NCI to create a position statement of the state of play so far:
"There is a growing imperative to modernize the drug development process by incorporating new techniques that can predict the safety and effectiveness of new drugs faster, with more certainty, and at lower cost."
As always, though, things are never as easy or simple as one might like.
Developing novel and useful biomarkers is an expensive and time consuming process driven largely by translational research and bioinformatics, often with a lot of diverse stakeholders involved in the process.
The Cancer Biomarkers Collaboration covered recommendations in eight key areas:
- Analytical performance
- Standardisation and harmonisation
- Collaboration and data sharing
- Regulatory issues
- Stakeholder education and communication
- Science policy
Ultimately, the goal of the collaboration is to:
"The AACR-FDA-NCI Cancer Biomarkers Collaborative is a stakeholder-driven effort to inform and accelerate the FDA Critical Path Initiative and the work of the broader cancer
The paper is well worth reading for those interested in the area, so check it out.
Meanwhile, on a practical note, a new potential biomarker has emerged in small cell lung cancer (SCLC) – see link to the Journal of Thoracic Oncology below (subscription required). The problem here is that while the majority of people with SCLC initially respond well to chemotherapy, resistance develops leading to relapse. The big question is why?
To answer this question, the researchers hypothesised that:
"… tumor microRNAs (miRNAs) could serve as predictive biomarkers for chemoresistance and prognostic biomarkers for survival of patients with SCLC treated with systemic chemotherapy."
The initial microRNA research on tumour samples (n=34) showed that:
"Higher tumor miR-92a-2* levels are associated with chemoresistance and with decreased survival in patients with SCLC.
Tumor miR-92a-2* may have application in screening patients with SCLC at risk for de novo chemoresistance in an effort to design more tailored clinical trials for this subpopulation."
In other words, microRNA (miR-92a-2*) could potentially be used as both a predictive and prognostic marker in SCLC. These results will need to be validated in larger scale trials, but they offer a promising glimpse of what might be possible for future therapeutic interventions.
Khleif, S., Doroshow, J., Hait, W., et al., (2010). AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: Advancing the Use of Biomarkers in Cancer Drug Development Clinical Cancer Research, 16 (13), 3299-3318 DOI: 10.1158/1078-0432.CCR-10-0880
Ranade, A., Cherba, D., Sridhar, S., Richardson, P., Webb, C., Paripati, A., Bowles, B., & Weiss, G. (2010). MicroRNA 92a-2* Journal of Thoracic Oncology DOI: 10.1097/JTO.0b013e3181dea6be