Contracting delays remain a challenge to the successful initiation of multisite clinical research in the US. The Clinical and Translational Science Awards (CTSA) Contracts Processing Study showed average contract negotiation duration of > 100 days for industry-sponsored or investigator-initiated contracts. Such delays create enormous costs to sponsors and to patients waiting to use new evidence-based treatments. With support from the National Institutes of Health’s National Center for Advancing Translational Sciences, the Accelerated Clinical Trial Agreement (ACTA) was developed by 25 major academic institutions and medical centers engaged in clinical research in collaboration with the University-Industry Demonstration Partnership and with input from pharmaceutical companies. The ACTA also informed the development of subsequent agreements, including the Federal Demonstration Partnership Clinical Trial Subaward Agreement (FDP-CTSA); both ACTA and the FDP-CTSA are largely non-negotiable agreements that represent pre-negotiated compromises in contract terms agreed upon by industry and/or medical center stakeholders. When the involved parties agree to use the CTSA-developed and supported standard agreement templates as a starting point for negotiations, there can be significant time savings for trials. Use of the ACTA resulted in an average savings of 48 days and use of the FDP-CTSA saved an average of 57 days of negotiation duration.

This article analyses the roles of the European Parliament and the US Congress in addressing regulatory interdependencies arising in the EU–US strategic partnership. It examines their international actorness as a potential remedy for the problems of democratic participation, executive dominance, and opaqueness in the shaping of transatlantic relations. It shows that legislatures significantly contribute to regulatory discrepancies and trade disputes and that the adverse consequences thereof justify more intensive ex ante cooperation between them. The analysis conducts two groups of case studies to demonstrate how the EP and Congress influence law and policy in areas of transatlantic regulatory and foreign policy divergence. The first group of case studies analyses parliamentary involvement in the making of international agreements (TTIP and ACTA). The second group of case studies inspects legislative action with extraterritorial effects (US Helms–Burton and Sarbanes–Oxley Acts). The article argues that the EP and Congress have so far frequently acted against the spirit of the strategic partnership in ways that are injurious to the interests of the other side, and discusses whether an interparliamentary early warning mechanism could reduce legislative and political frictions and increase the coherence of transatlantic lawmaking.