Clin­i­cal tri­als are of­ten short on se­niors

The Denver Post - - FEATURES - By Ju­dith Gra­ham

More than 60 per­cent of can­cer pa­tients are older adults — and that will rise to 70 per­cent by 2040. Yet se­niors are un­der­rep­re­sented 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 per­cent 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 per­cent of breast can­cer pa­tients are 75 or older, only 4 per­cent of breast can­cer clin­i­cal trial par­tic­i­pants are of this age.

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

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

The sober­ing con­clu­sion: “It’s dif­fi­cult to prac­tice ev­i­dence-based 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 grant to bring more se­niors and other un­der­rep­re­sented 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.”

Dif­fi­cul­ties en­rolling older peo­ple in re­search stud­ies ex­tend to Alzheimer’s dis­ease. With re­search fund­ing through the Na­tional In­sti­tutes of Health (NIH) now at nearly $1.4 bil­lion a year, “we’re go­ing to be see­ing more and more clin­i­cal tri­als, but it’s al­ready dif­fi­cult to get enough peo­ple to par­tic­i­pate,” said Keith Fargo, di­rec­tor of sci­en­tific pro­grams at the Alzheimer’s As­so­ci­a­tion.

Fewer than one-third of peo­ple di­ag­nosed with Alzheimer’s are el­i­gi­ble to join clin­i­cal tri­als, he said.

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. 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.”

Two years ago, ASCO is­sued new rec­om­men­da­tions call­ing for older adults to be in­cluded in more clin­i­cal tri­als. But progress has been slow, said Hyman Muss, di­rec­tor of geri­atric on­col­ogy at the Lineberger Com­pre­hen­sive Can­cer Cen­ter at the Uni­ver­sity of North Carolina at Chapel Hill.

“My view is that ev­ery pa­tient I see, if they’re el­i­gi­ble for a clin­i­cal trial, I’ll tell them about it,” he said.

Don’t as­sume your doc­tor will be equally forth­com­ing. “Ab­so­lutely, you should take the ini­tia­tive and ask,” Schilsky rec­om­mended. And don’t as­sume you need to have run out of op­tions be­fore do­ing so. “Clin­i­cal tri­als aren’t just for peo­ple who have no treat­ment op­tions left — that’s a com­mon mis­con­cep­tion,” Schilsky said.

Of course, clin­i­cal tri­als aren’t for every­one. Some older peo­ple are re­luc­tant to con­sider them be­cause they’re skep­ti­cal of un­proven ther­a­pies. Oth­ers may choose to fo­cus on their qual­ity of life in­stead of ag­gres­sive treat­ments.

For those who want to look for tri­als on their own, NIH spon­sors Clin­i­calTri­, a data­base of stud­ies around the world, search­able by dis­ease and ge­og­ra­phy. Tri­als To­day, cre­ated at Van­der­bilt Uni­ver­sity, is an ef­fort to make the NIH site more con­sumer-friendly. At Re­searchMatch, an­other Van­der­bilt ef­fort, peo­ple who want to par­tic­i­pate in stud­ies can sign up to be matched with clin­i­cal trial spon­sors. And Tri­alMatch, cur­rently list­ing more than 250 sci­en­tific stud­ies, is a one-stop-shop for clin­i­cal tri­als for peo­ple with Alzheimer’s dis­ease, their care­givers and peo­ple in­ter­ested in pre­vent­ing de­men­tia.

Make sure you run what­ever prospects you find by your doc­tor. “Very few pa­tients have the ex­per­tise to un­der­stand if a clin­i­cal trial is ap­pro­pri­ate for them,” Schilsky said. “You re­ally need an ex­pert opin­ion to help you un­der­stand what you find.”

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