Examination of Clinical Trial Costs and Barriers for Drug Development. 3.1 Costs by Therapeutic Area

07/25/2014

Table 1 presents the total costs for each of the therapeutic areas included in our model by clinical trial phase (assuming one trial per phase and not inclusive of failures). From the table, immunomodulation per-study costs ($6.6 million) are the highest in Phase 1 with costs of studies in ophthalmology ($5.3 million) and respiratory system ($5.2 million) ranking second and third, respectively. In Phase 2, hematology trial costs ($19.6 million) rank first, followed by pain and anesthesia ($17.0 million) and immunomodulation ($16.0 million). The most costly Phase 3 studies are in pain and anesthesia ($52.9 million) with studies in ophthalmology ($30.7 million) and cardiovascular ($25.2) area ranking second and third, respectively. In Phase 4, respiratory system trial costs ($72.9 million) rank first, followed by oncology ($38.9 million) and pain and anesthesia ($32.1 million) study costs. Overall, the therapeutic area with the highest clinical research burden across all phases is respiratory system ($115.3 million) followed by pain and anesthesia ($105.4 million) and oncology ($78.6 million) trials (see Figure 3). On the other hand, trials in central nervous system, dermatology, and genitourinary system tend to cost the least overall.

Table 1: Total Per-Study Costs (in $ Millions), by Phase and Therapeutic Area [a] [b]

Therapeutic Area Phase 1 Phase 2 Phase 3 Phase 1, 2, & 3 Subtotal [d] FDA NDA/BLA Review Phase [c] Phase 4 Total [d]
Anti-Infective $4.2 (5) $14.2 (6)  $22.8 (5) $41.2 (3) $2.0 $11.0 (12) $54.2 (10)
Cardiovascular $2.2 (9) $7.0 (13) $25.2 (3) $34.4 (10) $2.0 $27.8 (4) $64.1 (6)
Central Nervous System $3.9 (6) $13.9 (7) $19.2 (7) $37.0 (6) $2.0 $14.1 (11) $53.1 (11)
Dermatology $1.8 (10) $8.9 (12) $11.5 (13) $22.2 (13) $2.0 $25.2 (7) $49.3 (12)
Endocrine $1.4 (12) $12.1 (10) $17.0 (9) $30.5 (12) $2.0 $26.7 (6) $59.1 (7)
Gastrointestinal $2.4 (8) $15.8 (4) $14.5 (11) $32.7 (11) $2.0 $21.8 (8) $56.4 (8)
Genitourinary System $3.1 (7) $14.6 (5) $17.5 (8) $35.2 (8) $2.0 $6.8 (13) $44.0 (13)
Hematology $1.7 (11) $19.6 (1) $15.0 (10) $36.3 (7) $2.0 $27.0 (5) $65.2 (5)
Immunomodulation $6.6 (1) $16.0 (3) $11.9 (12) $34.5 (9) $2.0 $19.8 (9) $56.2 (9)
Oncology $4.5 (4) $11.2 (11) $22.1 (6) $37.8 (5) $2.0 $38.9 (2) $78.6 (3)
Ophthalmology $5.3 (2) $13.8 (8) $30.7 (2) $49.8 (2) $2.0 $17.6 (10) $69.4 (4)
Pain and Anesthesia $1.4 (13) $17.0 (2) $52.9 (1) $71.3 (1) $2.0 $32.1 (3) $105.4 (2)
Respiratory System $5.2 (3) $12.2 (9) $23.1 (4) $40.5 (4) $2.0 $72.9 (1) $115.3 (1)

[a] The numbers in parentheses represent the rank in descending order.
[b] The cost for each phase assumes that a single trial (i.e., study) is conducted.
[c] The category represents the New Drug Application (NDA)/Biologic License Application (BLA) filing fee for an application requiring clinical data and does not include any establishment or product fees that the filing entity might need to pay in addition.
[d] Totals may not add up due to rounding.


Figure 3: Clinical Trial Costs (in $ Millions) by Phase and Therapeutic Area

Figure 3: Clinical Trial Costs (in $ Millions) by Phase and Therapeutic Area

As can be observed from Table 1, Phase 2 costs are lower than Phase 3 costs for all but three therapeutic areas: gastrointestinal, hematology, and immunomodulation. This somewhat counterintuitive relationship is due to a variety of factors, including higher data collection costs, administrative staff costs, and site recruitment costs in Phase 2 than in Phase 3 for these therapeutic areas.

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