Post-approval indications and clinical trials for cardiovascular drugs: some implications of the US Inflation Reduction Act

Figures & data

Table 1. Post-approval indications.

	Total	%
Disease Area
New disease	27	38%
Not a new disease	45	62%
Patient Population
Adult	21	29%
Pediatric	15	21%
Both	1	1%
Not specified	35	49%
Indication Type
Treatment	39	54%
Prevention	29	40%
Both	4	6%
Total	72	100%

Source: Authors’ calculations of Drugs@FDA data.

Table 2. Drugs, indications, and industry-funded clinical trials by approval-year cohort.

	Drugs	Indications			Clinical Trials
	#	Total	Total Post-Approval	% Post-Approval	Total	Total Post-Approval Starts	% Post-Approval
Approval Cohort
1995-1999	19	45	23	51%	536	527	98%
2000-2004	14	35	19	54%	446	398	89%
2005-2009	6	9	3	33%	162	102	63%
2010-2014	13	35	20	57%	353	185	52%
2015-2019	9	18	7	39%	138	60	43%
2020-2021	4	4	0	0%	54	14	26%
Total	65	146	72	49%	1,689	1,286	76%

Source: Authors’ calculations of Drugs@FDA and ClinicalTrials.gov data.

Notes. Post-approval trials have start dates after US drug approval date; Post-approval indications have approval dates after US drug approval date; Cohort is defined by US drug approval year.

Figure 1. Post-approval indications per drug. Source: Authors’ calculations of Drugs@FDA data. Notes. Post-approval indications have approval dates after US drug approval date.

Figure 2. Post-approval industry-funded trial starts per drug. Source: Authors’ calculations of ClinicalTrials.gov data. Notes. Post-approval trials have start dates after US drug approval date.

Figure 3. Trial enrollment in post-approval industry-funded trials. Source: Authors’ calculations of ClinicalTrials.gov data. Notes. Post-approval trials have start dates after US drug approval date.

Table 3. Post-approval indications and industry-funded clinical trials by years from US drug approval (small molecules only).

	Indications				Clinical Trial Starts				Clinical Trial Ends
	All Post- Approval	5 years+	7 years+	9 years+	All Post- Approval	5 years+	7 years+	9 years+	All Post- Approval	5 years+	7 years+	9 years+
Approval Cohort
1995-1999	23	78%	57%	26%	526	94%	82%	65%	464	99%	97%	87%
2000-2004	19	47%	32%	21%	393	58%	48%	39%	362	78%	61%	49%
2005-2009	3	100%	100%	67%	102	25%	10%	7%	102	41%	26%	12%
2010-2014	20	50%	45%	30%	185	22%	10%	4%	185	45%	25%	10%
2015-2019	2	0%	0%	NA	33	9%	0%	NA	33	36%	21%	9%
2020-2021	0	NA	NA	NA	13	NA	NA	NA	13	23%	15%	8%
Total	67	60%	46%	27%	1,252	63%	52%	41%	1,159	76%	65%	53%

Source: Authors’ calculations of Drugs@FDA and ClinicalTrials.gov data.

Notes. Post-approval trials have start dates after US drug approval date; Post-approval indications have approval dates after US drug approval date; Cohort is defined by US drug approval year; Clinical trial ends are measured by primary completion date.

Figure 4. Cumulative Average Industry-Funded Post-Approval Trial Starts by Drug Approval Cohort. Source: Authors’ calculations of ClinicalTrials.gov data. Notes. Post-approval trials have start dates after US drug approval date. Cohort is defined by US drug approval year.