Vol­un­teer­ing for a study can help

Daily Freeman (Kingston, NY) - - YOUR DAILY BREAK - An­thony Ko­maroff Ask Dr. K

I have a par­tic­u­lar dis­ease. A nearby med­i­cal school is re­cruit­ing peo­ple with my con­di­tion to par­tic­i­pate in a re­search study. Should I vol­un­teer?

There are two good rea­sons to con­sider vol­un­teer­ing for a study: It might help you, and it might help oth­ers. In some types of stud­ies, there also may be risks to you.

Some­times my pa­tients ask me: “Do we re­ally need to do all th­ese med­i­cal re­search stud­ies? Don’t we know what treat­ments work with­out con­duct­ing and pay­ing for all th­ese stud­ies — of­ten with tax­payer dol­lars?”

That’s an easy ques­tion to an­swer. The his­tory of medicine is, un­for­tu­nately, filled with ex­am­ples of new treat­ments that doc­tors thought should work. In­deed, most doc­tors pre­dicted they would work. But when the treat­ments were tested, they didn’t work. In­deed, some­times they made peo­ple worse.

And some­times such treat­ments were given to many pa­tients be­fore a study was done to show that they were of no value, or even harm­ful.

Here are some things to con­sider as you de­cide whether to par­tic­i­pate.

Ev­ery study for which you might vol­un­teer has been care­fully de­signed. There is a de­tailed writ­ten plan spec­i­fy­ing ev­ery ques­tion you might be asked, the kind of phys­i­cal ex­am­i­na­tions that might be per­formed, the tests that might be or­dered and any treat­ments you might re­ceive.

This plan must be ap­proved by a com­mit­tee called an In­sti­tu­tional Re­view Board (IRB). The IRB in­cludes doc­tors, nurses, re­searchers and mem­bers of the com­mu­nity — none of whom is in­volved with the study. They de­ter­mine whether the study has ac­cept­ably low risks for the par­tic­i­pants.

There are dif­fer­ent types of stud­ies. Ob­ser­va­tional stud­ies sim­ply col­lect de­tailed in­for­ma­tion from you on an on­go­ing basis. They do not put you at risk. Stud­ies like this dis­cov­ered that peo­ple who smoked had a much higher risk of lung can­cer.

Other stud­ies, called clin­i­cal tri­als, re­quire you to have a par­tic­u­lar “in­ter­ven­tion.” The in­ter­ven­tion might be a di­ag­nos­tic test, such as a colonoscopy. Or it might be a treat­ment — a medicine, a sur­gi­cal pro­ce­dure or an­other ther­apy.

By par­tic­i­pat­ing in a clin­i­cal trial, you may get ac­cess to a ben­e­fi­cial drug or pro­ce­dure that is not yet on the mar­ket. On the other hand, there may be risks in­volved. One rea­son clin­i­cal tri­als are done is to de­ter­mine the ef­fec­tive­ness of a drug and any side ef­fects it may cause. Some clin­i­cal tri­als also test whether the study’s treat­ment is bet­ter than no treat­ment at all. So, if you en­roll in cer­tain types of stud­ies, you run the risk of be­ing as­signed to a placebo (sham) treat­ment.

Be­ing in a study won’t change your reg­u­lar med­i­cal care. You’ll still see your usual doc­tor. And typ­i­cally, the study (and its treat­ments) cost you noth­ing.

Many of my pa­tients have vol­un­teered to par­tic­i­pate in med­i­cal stud­ies. None I know of have ex­pe­ri­enced a com­pli­ca­tion, but it can hap­pen. Some of them have ben­e­fited: Their con­di­tion im­proved be­cause of the ex­per­i­men­tal treat­ment used in the study.

Dr. Ko­maroff is a physi­cian and pro­fes­sor at Har­vard Med­i­cal School.)

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