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
Drug	NDA sponsor	Short indication*	# Trials analysed	% Registered	% Reported	% Published	% Publicly available‡	# Trials analysed	% Registered	% Reported	% Published	% Publicly available
Xtoro	Alcon/Novartis†	Otitis externa	3	67	67	0	67	4	50	50	0	50
Esbriet	Genentech/Roche †	Pulmonary fibrosis	10	46	40	70	70	17	33	24	47	47
Harvoni	Gilead	Hepatitis C	31	92	61	68	74	60	53	32	37	40
Dalvance	Durata/Allergan	Skin infection	8	50	25	75	75	22	18	9	68	68
Zydelig	Gilead	Leukaemia	5	100	60	60	80	16	58	19	19	25
Sivextro	Cubist/Merck†	Skin infection	7	100	57	71	86	21	90	19	67	71
Zontivity	MerckSharpDohme	Thrombotic Cardiovascular events	7	86	71	71	86	27	26	19	74	78
Xigduo XR	AstraZeneca†	Type 2 diabetes	20	100	70	80	90	25	85	56	64	72
Farxiga	AstraZeneca†	Type 2 diabetes	39	91	49	85	92	58	76	34	78	84
Lynparza	AstraZeneca	Ovarian cancer	24	96	92	75	96	24	96	92	75	96
Zykadia	Novartis	Lung cancer	1	100	100	100	100	5	69	20	20	20
Belsomra	MerckSharpDohme	Insomnia	6	100	100	100	100	37	24	22	27	32
Cerdelga	Genzyme/Sanofi	Gaucher disease	3	100	100	100	100	16	41	19	38	38
Viekira Pak	Abbvie	Hepatitis C	15	100	87	100	100	59	35	22	58	58
Otezla	Celgene	Arthritis; psoriasis	15	93	93	80	100	30	57	47	53	63
Jublia	Dow/Valeant	Onychomycosis	5	60	0	100	100	9	33	0	78	78
Movantik	AstraZeneca	Constipation	6	100	100	67	100	20	85	85	60	85
Invokamet	Janssen/J&J†	Type 2 diabetes	22	100	100	100	100	40	88	63	85	88
Zerbaxa	Cubist/Merck	Urinary and abdominal infections	6	100	100	100	100	15	50	40	93	93
Quartile 1			5	86	57	70	80	16	33	19	37	40
Quartile 3			20	100	100	100	100	37	85	50	75	84
Median			7	100	71	80	96	22	53	24	60	68

*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.