ASCO Report Argues Clinical Research Needs to Keep Up with Cancer Science

A new approach to therapy development, ‘smarter’, faster clinical trials and optimisation of health information technology are needed to deliver fully on the innovative advances in cancer seen in recent years, a new report claims.

The report from the American Society of Clinical Oncology (ASCO), the world’s leading professional organization representing physicians who care for people with cancer, acknowledges the rapid growth in understanding of cancer biology that is spawning a new generation of targeted therapies.

At the same time, it notes, cutting-edge technologies in fields such as computational chemistry, medical imaging and genetic engineering are multiplying the channels and potential for drug development.

Yet the US clinical research system and drug development infrastructures for oncology are not properly equipped to deliver on the promise of these advances, claims the report.

Limited understanding

The report claims that drug development in the field is hampered by researchers’ limited understanding of which molecular pathways to target, by a shortage of diagnostics to identify those patients most likely to benefit from particular interventions, and by financial and regulatory barriers that restrict the ability of companies and researchers to collaborate on new approaches.

Clinical trials have not kept pace with the shift towards personalised medicine in oncology, the report adds. Study designs lack the flexibility to provide quick answers about treatments tailored to specific groups of patients defined molecular terms. And cancer trials in general have been “weakened by a labyrinth of regulatory requirements and years of under-funding”, ASCO says.

In addition, the promise of health information technology (HIT) in the field “is only beginning to be realised”, due to restricted, uncoordinated and inconsistent use of electronic health records (EHRs) and other HIT tools in research and patient care.

Real-world recommendations

For cancer research and care to become significantly more targeted, efficient and effective over the next decade, ASCO believes three “real-world” recommendations need to be addressed:

•    A new approach to therapy development, underpinned by better understanding of cancer biology and driven by new technologies. This would include:

–    Identifying and prioritising molecular targets with the most promise to improve survival;

–    incentivising collaboration to encourage high-priority targeted therapies and diagnostics;

–    ensuring more aggressive and timely development of biomarkers and diagnostic tests to guide treatment decisions and accelerate research.

•    Smarter and faster clinical trials that would provide evidence more promptly for effective treatments targeting those patients most likely to benefit. This would involve:

–    prioritising trials that offer the most significant potential benefits for patients or address clear unmet needs, while shifting the emphasis away from studies that promised only marginal improvements;

–    developing shared standards for flexible trial designs that allow researchers to demonstrate results in smaller populations defined by specific molecular characteristics;

–    selecting trial participants based primarily on molecular characteristics, to ensure that only those most likely to benefit are included and that patients are not excluded from trials due to irrelevant health conditions;

–    revitalising the National Cancer Institute’s Clinical Trials Cooperative Group Program, which “has been instrumental in much of the progress achieved against cancer to date”.

•    Harnessing advances in health information technology to integrate clinical research and patient care seamlessly. For example:

–    Exploiting HIT tools, including EHRs and ‘rapid learning’ systems, so that researchers could draw on “the wealth of real-world patient information that is now locked away in file cabinets and unconnected computer systems”;

–    standardising EHRs by defining functional requirements, harmonising data fields and ensuring secure patient and provider access to information at any time;

–    developing industry standards for working with, storing and capturing information from biospecimens (tissue and blood samples);

–    examining the need for revised standards around patient privacy, information sharing and intellectual property protection to support HIT innovation.

ASCO president Dr Michael Link, commented that “advances in cancer prevention, detection and treatment have already extended the lives of millions of adults and children living with cancer – but the critical question is, ‘Where do we go from here?’.”

With the burden of cancer growing rapidly worldwide, “millions of future patients are depending on the answer,” he added.


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