Table 2

Transparency of clinical trials in patients and all clinical trials listed in NDAs

Ethics standard A: trials in patients (excluding healthy volunteer trials)Ethics standard B: all clinical trials
DrugNDA sponsorShort indication*# Trials analysed% Registered% Reported% Published% Publicly available‡# Trials analysed% Registered% Reported% Published% Publicly available
XtoroAlcon/Novartis†Otitis externa3676706745050050
EsbrietGenentech/Roche †Pulmonary fibrosis10464070701733244747
HarvoniGileadHepatitis C31926168746053323740
DalvanceDurata/AllerganSkin infection850257575221896868
SivextroCubist/Merck†Skin infection71005771862190196771
Cardiovascular events
Xigduo XRAstraZeneca†Type 2 diabetes201007080902585566472
FarxigaAstraZeneca†Type 2 diabetes39914985925876347884
LynparzaAstraZenecaOvarian cancer24969275962496927596
ZykadiaNovartisLung cancer1100100100100569202020
CerdelgaGenzyme/SanofiGaucher disease31001001001001641193838
Viekira PakAbbvieHepatitis C15100871001005935225858
OtezlaCelgeneArthritis; psoriasis159393801003057475363
InvokametJanssen/J&J†Type 2 diabetes221001001001004088638588
ZerbaxaCubist/MerckUrinary and
abdominal infections
Quartile 15865770801633193740
Quartile 3201001001001003785507584
  • *Full FDA approved indications are listed in online supplementary appendix 6.

  • †Some trials for these drugs were sponsored by a company other than the NDA sponsor, including the below.

  • Xtoro: Alcon sponsored three trials; two had publicly disclosed results, one trial was not registered. Novartis states that the unregistered trial ‘was conducted before the Novartis position to register all phase I trials in patients became applicable to Alcon. Alcon was purchased by Novartis in April 2011’.

  • Esbriet: Intermune sponsored two trials; both had publicly disclosed results. Marnac sponsored four trials; two were publicly disclosed. Two trials were investigator initiated and were both publicly available. Genentech merged with Intermune in 2014. Intermune purchased the rights to sell Esbriet in the USA in 2007.

  • Sivextro: Bayer/Trius sponsored 21 trials, 15 had public results. Bayer and Trius partnered to develop Sivextro (2011). Cubist acquired Trius (2013). Merck acquired Cubist (2014).

  • Xigduo XR: BMS cosponsored 16 trials with AstraZeneca; 14 had publicly disclosed results.

  • ‡Ranking of drugs.

  • Farxiga:  BMS cosponsored multiple trials with AstraZeneca.

  • Invokamet: Mitsubishi Tanabe sponsored four trials; all had publicly disclosed results. Misubishi was Johnson & Johnson’s research partner in Japan.

  • BMS, Bristol Myers Squib; NDA, new drug application.