Building a drug development database: challenges in reliable data availability

Figures & data

Figure 1. IND date availability per year. Notes: IND dates were identified and collected from two primary public sources: the Drugs@FDA database and the Federal Register. The availability of dates varied over time, both by total availability of IND dates year-to-year and availability by source.

Figure 2. IND date availability per data source. Notes: IND dates were identified and collected from two primary public sources: the Drugs@FDA database and the Federal Register. The availability of dates varied over time, both by total availability of IND dates year-to-year and availability by source.

Table 1. Number of NMEs by date entry and data source.

	# NME (%)
	Drugs@FDA only	FR only	Both sources	Total
One IND date	126 (85%)	45 (32%)	0	171 (38%)
Two IND dates	18 (12%)	97 (68%)	39 (25%)	154 (35%)
Three IND dates	3 (2%)	0	108 (70%)	111 (25%)
Four IND dates	1 (1%)	0	7 (5%)	8 (2%)
Five IND dates	0	0	1 (1%)	1 (0.2%)
Total	148	142	155	445

For 274 NMEs, more than one IND date was reported between the Drugs@FDA database and the Federal Register. The majority of NMEs with multiple IND dates were found in the Federal Register only (97 NMEs) or due to three different dates reported between both sources (108 NMEs).

Table 2. Gaps between multiple dates reported for the same NME.

	# NME (%)
Gap between IND dates per sources	Drugs@FDA only	FR only	Both sources	Total
Exact match	0 (0%)	19 (20%)	2 (1%)	21 (8%)
No more than 1 month	6 (27%)	65 (67%)	53 (34%)	124 (45%)
1 month to 12 months	6 (27%)	9 (9%)	58 (37%)	73 (27%)
13 months to 5 years	8 (36%)	3 (3%)	18 (12%)	29 (11%)
Over 5 years to 10 years	0 (0%)	1 (1%)	12 (8%)	13 (5%)
Over 10 years	2 (9%)	0	9 (6%)	11 (4%)
Undetermined^a	0		3 (2%)	3 (1%)
Total	22	97	113	274

^a The Drugs@FDA database only mentioned the year the IND was filed. In the absence of a date and month, it was not possible to calculate the gap between the various dates.

For the 274 NMEs with multiple IND dates reported, there is a considerable variation in the gap between the most extreme possible dates. This variability ranged from a difference between dates of no more than one month and a difference of over 10 years.