Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of un­re­leased tri­al da­ta may soon see the light of day.

A New York fed­er­al judge ruled this week that the FDA and the NIH have for years mis­in­ter­pret­ed a law that would re­quire com­pa­nies, uni­ver­si­ties and oth­er clin­i­cal tri­al spon­sors to re­lease tri­al da­ta from stud­ies com­plet­ed be­tween 2007 and 2017. The rul­ing cov­ers drugs and med­ical de­vices that were ex­per­i­men­tal when the study was com­plet­ed but have since been ap­proved, po­ten­tial­ly putting hun­dreds of spon­sors out of com­pli­ance if they don’t put their re­sults on clin­i­cal­tri­

The FDA had been in­ter­pret­ing a ‘fi­nal rule’ added to 2007 law, known as the Food and Drug Ad­min­is­tra­tion Amend­ments Act, to mean that spon­sors on­ly had to re­port re­sults for tri­als that were com­plet­ed af­ter the law rule was pro­mul­gat­ed in 2017. Plain­tiffs said it was retroac­tive.

“The court has set aside that er­ro­neous in­ter­pre­ta­tion of the law and has said that the statute means what it has al­ways said,” Christo­pher Morten, the lawyer for the plain­tiffs, told End­points News. “So our hope here is that tri­al spon­sors are go­ing to start, fi­nal­ly, af­ter years of non­com­pli­ance, re­port­ing some of that miss­ing da­ta to the pa­tients.”

The FDA and the NIH did not put out state­ments fol­low­ing the rul­ing and did not im­me­di­ate­ly re­spond to re­quests for com­ment.

FDAAA was the law that re­quired spon­sors to reg­is­ter most tri­als on clin­i­cal­tri­, and in 2018 the change went in­to ef­fect re­quir­ing that com­pa­nies post re­sults with­in a year of the tri­al’s com­ple­tion. The gov­ern­ment in­ter­pret­ed it to mean on­ly the re­sults of tri­als com­plet­ed af­ter the law went in­to ef­fect.

The FDA and NIH’s ex­e­cu­tion of that rule, though, has been the sub­ject of ma­jor scruti­ny in the last few months. In­ves­ti­ga­tions in The Lancet and in Sci­ence pub­lished in Jan­u­ary found that tri­al spon­sors have wide­ly ig­nored the re­port­ing re­quire­ments since 2018. The Lancet study, by Ben Goldacre, found on­ly 41% of over 4,700 tri­als re­port­ed on time.  An­a­lyz­ing a sim­i­lar dataset, Sci­ence’s Charles Piller found 45% non­com­pli­ance and iso­lat­ed a group of 30 “ha­bit­u­al of­fend­ers” who col­lec­tive­ly failed to re­port the re­sults 67% of the time.

Ad­vo­cates for greater trans­paren­cy say this kind of ob­fus­ca­tion hurts the field by giv­ing doc­tors and re­searchers on­ly a par­tial glimpse at the over­all re­sults. It can even be dan­ger­ous, Morten ar­gued. He cit­ed Vioxx, the painkiller Mer­ck pulled off the mar­ket in 2004 af­ter stud­ies showed an in­creased risk of stroke. Had Mer­ck dis­closed pre-ap­proval tri­al re­sults soon­er, Morten said, the risk could have been caught soon­er.

The case was brought by for­mer as­so­ciate FDA com­mis­sion­er Pe­ter Lurie and NYU jour­nal­ist Charles Seife, who ar­gued a mis­in­ter­pre­ta­tion of the rule has im­ped­ed their work more broad­ly. The rul­ing takes the re­port­ing re­quire­ments pre­vi­ous­ly ap­plied on­ly to tri­als com­plet­ed since 2018 and ap­plies them to those com­plet­ed since 2007.

“That’s hurt pa­tients who lack the op­por­tu­ni­ty to learn about the drugs they take, it’s hurt doc­tors that lack in­for­ma­tion on the drugs they pre­scribe, and it’s hurt re­searchers like Charles and Pe­ter,” Morten said.

It’s not clear, though, how the rul­ing will be en­forced. The plain­tiffs were over­ruled on a sep­a­rate is­sue, in which they ar­gued the FDA and NIH were not abid­ing by a statute re­quir­ing them to give pub­lic no­tice of non­com­pli­ance to com­pa­nies not abid­ing by the FDAAA rules.

The gov­ern­ment could yet ap­peal the rul­ing but it’s not yet clear if they will.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

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