So you think you can an­a­lyze data?

Modern Healthcare - - NEWS - By El­iz­a­beth Whit­man

In the third year of what was sup­posed to be a five-year study, the data safety board mon­i­tor­ing the Sys­tolic Blood Pres­sure In­ter­ven­tion Trial called it to a halt as the gap in deaths widened be­tween the two groups in the study.

Par­tic­i­pants in the group that was treated more ag­gres­sively—who were given med­i­ca­tion to keep their sys­tolic blood pres­sure to 120 mm Hg or be­low—were clearly far­ing bet­ter than those in the com­par­i­son group be­ing treated with a com­mon tar­get of 140 mm Hg or less. In the first co­hort, 155 par­tic­i­pants died; in the lat­ter, 210 did. To pro­ceed would not have been eth­i­cal, agreed re­searchers at the Na­tional Heart, Lung and Blood In­sti­tute.

But although the trial showed that more ag­gres­sively con­trol­ling hy­per­ten­sion saved lives, it raised other ques­tions, and it left be­hind a wealth of pris­tine clin­i­cal data, po­ten­tially chock-full of hid­den an­swers.

Now, the public will get a chance to learn more from that trial. In a new com­pe­ti­tion, the New Eng­land Jour­nal of Medicine, which pub­lished the re­sults of the Sys­tolic Blood Pres­sure In­ter­ven­tion Trial, or Sprint, last Novem­ber, is calling on data an­a­lysts, re­searchers and any­one else who’s in­ter­ested to take a fresh look at the Sprint data and glean new find­ings.

“We’re pretty sure that such in­for­ma­tion is there, but we don’t know what it is,” said Dr. Jeff Drazen, ed­i­torin-chief of the New Eng­land Jour­nal of Medicine. “We’re chal­leng­ing ev­ery­body in the world. You can be in Bangladesh or New Zealand or some­where in China and ac­cess the data set and teach the world some­thing.”

Par­tic­i­pants in the Sprint Data Anal­y­sis Chal­lenge could un­cover a char­ac­ter­is­tic among cer­tain pa­tients that makes low­er­ing blood pres­sure

Although the trial showed that more ag­gres­sively con­trol­ling hy­per­ten­sion saved lives, it raised other ques­tions, and it left be­hind a wealth of pris­tine clin­i­cal data, po­ten­tially chock-full of hid­den an­swers.

un­nec­es­sary, while for oth­ers do­ing so could even be ex­ces­sively risky. Find­ings un­earthed dur­ing this re-ex­am­i­na­tion of the Sprint data could spur fol­low-up clin­i­cal tri­als.

The idea that data-shar­ing im­proves med­i­cal re­search has gained steam in re­cent years. If the Sprint chal­lenge pro­duces use­ful in­for­ma­tion, it would add ev­i­dence to shore up that be­lief.

“Although clin­i­cal tri­als gen­er­ate vast amounts of data, a large por­tion is never pub­lished or made avail­able to other re­searchers,” the Na­tional Acad­e­mies Press said in is­su­ing a Jan­uary 2015 re­port, Shar­ing Clin­i­cal Trial Data: Max­i­miz­ing Ben­e­fits, Min­i­miz­ing Risk. “Data shar­ing could ad­vance sci­en­tific dis­cov­ery and im­prove clin­i­cal care by max­i­miz­ing the knowl­edge gained from data col­lected in tri­als, stim­u­lat­ing new ideas for re­search, and avoid­ing un­nec­es­sar­ily du­plica­tive tri­als.”

In Jan­uary 2016, the In­ter­na­tional Com­mit­tee of Med­i­cal Jour­nal Ed­i­tors ar­gued in an ed­i­to­rial in the New Eng­land Jour­nal of Medicine that re­spon­si­bly shar­ing data from in­ter­ven­tional clin­i­cal tri­als con­sti­tuted “an eth­i­cal obli­ga­tion.”

To ac­cess the data in the Sprint chal­lenge, en­trants have to ob­tain ap­proval or an ex­emp­tion cer­tifi­cate from an in­sti­tu­tional re­view board or ethics com­mit­tee. That clear­ance will show that en­trants are se­ri­ous about the work and that they’re qual­i­fied to do it.

Ap­pli­cants will be able to ac­cess the data start­ing Nov. 1. They must pass a qual­i­fy­ing round by demon­strat­ing their com­pe­tency in work­ing with the data be­fore they can en­ter the chal­lenge round, which runs from Dec. 1 to Feb. 14, 2017. They are al­lowed to use other pub­licly avail­able data sets in ad­di­tion to the Sprint data.

In shar­ing their find­ings, par­tic­i­pants have to ex­plain not only what they dis­cov­ered but also how they did so. That re­quire­ment, plus the fact that ev­ery­one will have ac­cess to the same data, is in­tended to pre­vent par­tic­i­pants from fal­si­fy­ing their find­ings.

The win­ner will re­ceive $5,000 and will present the find­ings at a Bos­ton sum­mit on shar­ing clin­i­cal trial data in April 2017. Sec­ond- and third-place win­ners will be awarded $2,500 and $1,500, re­spec­tively, and will also re­ceive trips to the sum­mit.

In a way, the med­i­cal and re­search worlds owe this sec­ondary anal­y­sis to the 9,361 par­tic­i­pants in Sprint, Drazen sug­gested. “They put them­selves at risk, and as a re­sult, there were peo­ple who ac­tu­ally died be­cause of one group as­sign­ment, com­pared to the other.”


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