How It Began

Contract negotiations are a complex process and are often identified as a major barrier to efficient study initiation. Data from a 2010 CTSA sites contracts processing study ⁽¹⁾ showed that an average contract terms negotiation time of 55 days could be reduced to 22 days if a ‘master agreement’ was used. As an attempt to remedy this hurdle, the CTSA Master Contracts Working Group, made up of legal experts from ~25 CTSA institutions, collaborated with industry and the University Industry Demonstration Partnership to develop a standardized clinical trial agreement – a single agreement to be used (voluntarily) by each participating institution and sponsor, to reduce contract negotiations for industry sponsored multi-site studies. This agreement is known as the Accelerated Clinical Trial Agreement (ACTA).

Final draft language was reviewed and agreed to by industry sponsors, organizations, and academic institutions to arrive at the final agreement, followed by review by a larger workgroup with representatives from each of the > 60 CTSAs. The ACTA was then piloted with five studies from five unique sponsors across ~ 40 sites to look for serious flaws in the document. There were no substantive changes and after several months of socializing the terms through meetings with the CTSAs, the ACTA was published in October 2014.

Benefits

The ACTA was prepared with the intent to facilitate relationships with industry sponsors that are interested in expediting the contract process thus optimizing lag time for research. The underlying principles used in the construction of the ACTA are that it represents a straightforward and unambiguous position which clearly sets forth the regulatory and contractual obligations of both parties, and presents language while perhaps not ideal to either party, is acceptable to both.

Data for ACTA usage in a 24-month period (2015-2017) indicate the agreement was used ~90 times with an approximate time savings of 40 days (estimates were highly variable of 7 days to 6 months).² A follow up survey of CTSA sites for a 24-month period (2019-2021) showed that the ACTA was used 122 times across seven sites with an average time savings of ~55 days compared to no ACTA or master agreement. To date, more than 350 research sites, including academic medical centers, universities, hospitals and physician practices and industry sponsors, have agreed to the terms of the ACTA and accept the ACTA without revision.

References

(1) Kiriakis J, Gaich N, Johnston SC, Kitterman D, Rosenblum D, Salberg L, Rifkind A. Observational study of contracts processing at 29 CTSA sites. Clin Transl Sci. 2013 Aug;6(4):279-85. doi: 10.1111/cts.12073. Epub 2013 Jun 10. Erratum in: Clin Transl Sci. 2014 Aug;7(4):348. PMID: 23919362; PMCID: PMC3740442.

(2) Lawrence CE, Bruce VNM, Salberg LD, Edwards T, Morales C, Palm M, Bernard GR. Quantitative assessment of the impact of standard agreement templates on multisite clinical trial start up time. J Clin Transl Sci. 2023 Sep 6;7(1):e204. doi: 10.1017/cts.2023.622. PMID: 37830004; PMCID: PMC10565190.