HHS in­spec­tor gen­er­al: NIH failed to ver­i­fy clin­i­cal tri­al re­sults were re­port­ed on time

Most NIH-fund­ed clin­i­cal tri­als with re­sults due in 2019 and 2020 did not meet fed­er­al re­port­ing re­quire­ments, the HHS in­spec­tor gen­er­al’s of­fice said in an au­dit re­leased Tues­day.

The au­dit re­vealed that of 72 in­tra­mur­al and ex­tra­mur­al tri­als with re­sults due in 2019 and 2020, on­ly 35 sub­mit­ted re­sults were on time, while 12 were sub­mit­ted late, and 25 nev­er sub­mit­ted.

“NIH did not have ad­e­quate pro­ce­dures for en­sur­ing that re­spon­si­ble par­ties sub­mit­ted the re­sults of clin­i­cal tri­als, took lim­it­ed en­force­ment ac­tion when there was non­com­pli­ance, and con­tin­ued to fund new re­search of re­spon­si­ble par­ties that had not sub­mit­ted the re­sults of their com­plet­ed clin­i­cal tri­als,” HHS’ OIG re­port says.

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