Clin­i­cal tri­als are of­ten short on se­niors

The Hamilton Spectator - - HEALTH - JU­DITH GRA­HAM

More than 60 per cent of can­cer pa­tients are older adults — and that will rise to 70 per cent by 2040. Yet se­niors are un­der-rep­re­sented in clin­i­cal tri­als, mak­ing it dif­fi­cult to as­sess how treat­ments are likely to help or harm them.

The new­est ev­i­dence of the im­bal­ance comes from a Food and Drug Ad­min­is­tra­tion anal­y­sis. It found that only 40 per cent of pa­tients par­tic­i­pat­ing in can­cer clin­i­cal tri­als were 65 and older. The anal­y­sis was pre­sented last month at the annual meet­ing of the Amer­i­can So­ci­ety of Clin­i­cal On­col­ogy (ASCO).

Clin­i­cal tri­als in­ves­ti­gate the safety and ef­fec­tive­ness of new drugs and ther­a­pies, as well as ways to pre­vent ill­ness and de­tect con­di­tions early. Their find­ings help guide med­i­cal prac­tice.

Yet, older adults are of­ten not in­cluded in re­search stud­ies to any sig­nif­i­cant ex­tent. This is es­pe­cially true for can­cer pa­tients in their 70s and 80s, ac­cord­ing to the FDA’s data:

• While 19 per cent of breast can­cer pa­tients are 75 or older, only 4 per cent of breast can­cer clin­i­cal trial par­tic­i­pants are of this age.

• Al­though 33 per cent of colon can­cer pa­tients are in the 75-an­dolder group, a mere 8 per cent of pa­tients stud­ied by re­searchers fell into that age group.

• While 37 per cent of lung can­cer pa­tients are 75 or older, only 9 per cent of peo­ple of that age are rep­re­sented in lung can­cer clin­i­cal tri­als.

The sober­ing con­clu­sion: “It’s dif­fi­cult to prac­tice ev­i­dence­based medicine in an older pop­u­la­tion be­cause the data isn’t there,” said Stu­art Licht­man, a pro­fes­sor of medicine at Weill Cor­nell Med­i­cal Col­lege in New York and pres­i­dent of the In­ter­na­tional So­ci­ety of Ge­ri­atric On­col­ogy.

And it’s not just can­cer. Across med­i­cal con­di­tions that dis­pro­por­tion­ately af­fect se­niors, peo­ple 65 and older have a poor show­ing in clin­i­cal tri­als.

“There’s of­ten an as­sump­tion that drugs only need to be tested in younger peo­ple and re­sults can be ex­trap­o­lated,” said Con­suelo Wilkins, an as­so­ci­ate pro­fes­sor of medicine at Van­der­bilt Uni­ver­sity Med­i­cal Cen­ter who, with col­leagues, is over­see­ing a ma­jor grant to help bring more se­niors, blacks, His­pan­ics and other groups into clin­i­cal tri­als. “But we know that how older adults re­spond to med­i­ca­tions and in­ter­ven­tions and their risk for ad­verse events is dif­fer­ent based on their phys­i­ol­ogy.”

Re­searchers of­ten find older adults un­suit­able for tri­als for mul­ti­ple rea­sons: Se­niors may have mul­ti­ple ill­nesses — di­a­betes and hy­per­ten­sion in ad­di­tion to can­cer or Alzheimer’s dis­ease — that could com­pli­cate the study’s re­sults, or they may al­ready be tak­ing med­i­ca­tions that could in­ter­act with ther­a­pies be­ing ex­am­ined.

Also, older adults may live alone and not have some­one who can ac­com­pany them to the study site for tests and pro­ce­dures — a sig­nif­i­cant con­cern for Alzheimer’s tri­als, which typ­i­cally re­quire a care­giver to pro­vide in­put about the pa­tient’s con­di­tion and progress. Also, some se­niors can’t get around eas­ily. And some are frail.

Re­spon­si­bil­ity falls to a large ex­tent on physi­cians, said Richard Schilsky, chief med­i­cal of­fi­cer for ASCO, not­ing that “they don’t ask older adults whether they want to par­tic­i­pate or not. It’s a com­bi­na­tion of con­cern that older pa­tients might be un­able to com­ply with a trial’s re­quire­ments, which are usu­ally quite rig­or­ous, and con­cern that spec­i­fied ther­a­pies might be too toxic.”

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