Clinical Trials Lack Seniors, Newborns

What do newborns and senior citizens have in common?  Neither are showing up for clinical trials.

And that’s a problem, says the Coalition for Clinical Trials Awareness.  The organization has dedicated its annual Clinical Trials Awareness Week, April 30-May 4 to highlighting the need for age diversity in research on new drugs.

Capitol Hill Event

Newborn participation took center stage during a May 1 Capitol Hill policy panel, co-hosted by the Coalition for Clinical Trials Awareness and the National Coalition for Infant Health.  Moderated by Alliance for Patient Access Chairman David Charles, MD, the panel explored the challenges and barriers to enrolling newborns in clinical trials.

“Enrollment of children and infants is woefully inadequate,” Dr. Charles explained, adding that 90 percent of medications given to infants have never been FDA-tested for that age group.

Panelists included:

  • Jaszianne A Tolbert, MD, of Children’s Mercy Hospital’s Experimental Therapeutics in Cancer Dr. Tolbert, who diagnoses and treats children with cancer, explained how patient stories help her communicate the importance of clinical trials for children.

Dr. Tolbert conveyed the experience of Bailey, a girl diagnosed with leukemia at two months old.  Doctors left Bailey’s mother with little hope, encouraging her to simply “love on [her] daughter” as much as time allowed.  Then, after one month in a clinical trial, Bailey found herself in disease remission.

Murray emphasized the importance of trials participation and new treatments for children, describing how a combination of guidance from a patient advocacy organization, webinars and independent research helped him and his wife find treatment options for their daughter.

  • Andrew Rosenberg of the Newborn Health Initiative. A preemie at birth, Rosenberg described how the Promoting Life Saving New Therapies for Neonates Act, H.R. 2641, could incentivize industry to develop more drugs specifically for newborns.

The bill could be an important step toward ending the “innovation desert” that plagues the field of newborn medicines, Rosenberg explained.  Sponsored by Rep. Billy Long (R-MO) and Rep. Ben Ray Juján (D-NM), the bill was last referred to the House Subcommittee on Health.

Twitter Town Hall

Meanwhile, a Twitter chat hosted by the Coalition for Clinical Trials Awareness on Wednesday raised the issue of too few senior citizens, as well as too few newborns, in clinical trials.  The event drew participation from a range of individuals and organizations, including Stand Up To Cancer, The Michael J. Fox Foundation and the Alliance for Aging Research.

“When older adults aren’t given the opportunity or don’t participate in clinical trials, we remain uninformed about clinical responses of older cancer patients to new cancer treatments being studied,” Stand Up To Cancer tweeted.

The Alliance for Aging Research cited “a high likelihood of comorbidity exclusion, perceived financial issues, transportation barriers & fear of science and the system” as common barriers to clinical trials participation.

Participation among Seniors and Newborns

The underrepresentation of newborns and senior citizens in clinical trials can have serious ramifications for the health care available to these populations.  People age 65 and older represent only about 13 percent of the population, but they account for roughly one-third of all medications consumed.  Not testing medications on this population can leave gaps in knowledge about how senior citizens will respond to certain drugs.

Lack of newborn participation presents equal concerns.  About 4 million babies are born in the United States each year; 200,000 of them require admission to a neonatal intensive care unit.  Yet the last currently available drug tested and approved specifically for newborns was approved about 20 years ago.

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