Clinical trials should include older adults, ASCO urges

The American Society of Clinical Oncology (ASCO) has called on federal agencies and the cancer research community to broaden clinical trials to include older adults.

They also called for work to be done to redefine the eligibility for clinical trials. Both calls to action were published in the Journal of Clinical Oncology.

In the US, more than 60% of cancers occur in people age 65 and older. Due to an ageing population, this will likely increase over the coming years, yet the evidence base for treating older adults is sparse as they are underrepresented in clinical trials and trials designed specifically for them are rare.

As a result, ASCO’s Cancer Research Committee has published a position statement, Improving the Evidence Base for Treating Older Adults with Cancer, which makes 5 recommendations:

Use clinical trials to improve the evidence base for treating older adults
Leverage research designs and infrastructure to improve the evidence base for treating older adults
Increase Food and Drug Administration (FDA) authority to incentivise and require research on older adults with cancer
Increase clinicians’ recruitment of older adults with cancer into clinical trials
Utilise journal policies to incentivise researchers to consistently report on the age distribution and health risk profiles of research participants.

ASCO also details 16 specific action steps to implement its recommendations, including asking regulatory agencies, research funders and researchers to consider whether evidence exists to support eligibility criteria based on age, performance status or comorbid conditions – three primary reasons older adults are excluded from clinical trials.
Furthermore, ASCO encourages researchers to adopt innovative trial designs that would fill knowledge gaps in the treatment of older adults with cancer.

“Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,” said ASCO President Julie M. Vose. “As we age, for example, the risk of adverse reactions from treatment significantly increases. Older adults must be involved in clinical trials so we can learn the best way to treat older cancer patients resulting in improved outcomes and manageable toxicity.”

Redefining Eligibility Criteria for Clinical Trials

In a related effort, ASCO’s Cancer Research Committee released a paper, Modernizing Eligibility Criteria for Molecularly Driven Trials, which examines the need to redefine eligibility criteria around the specific population being researched especially as molecular medicine advances.

Now, to advance the issues raised in its position statement and paper, ASCO plans to organise a public meeting with input from regulatory bodies and key stakeholders with the ultimate goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols which may help guide future investigators in the era of molecularly-driven therapy. The meeting will be held in autumn 2016.

To read both statements, please click on the titles below:

Both calls to action were published in the Journal of Clinical Oncology.