Clinical trial startup delays driven by protracted legal negotiations remain a major bottleneck in oncology research. In response, CEORT, in partnership with the National Cancer Institute (NCI), launched the START Clauses initiative to streamline contracting through a standardized set of legal provisions. Building on the original framework’s success, START Clauses 2.0 introduces a modular, next-generation framework addressing the growing complexity of modern oncology trials.
The Original START Clauses (2005–2011)
The START initiative was built on a systematic and evidence-based foundation. CEORT mobilized its Life Sciences Consortium—comprising senior executives from 11 global pharmaceutical companies—and engaged legal experts, NCI officials, and academic research leaders in a unified effort to standardize clinical contracting practices. Drawing on actual redacted final contracts in use by both industry and 14 NCI-designated Cancer Centers, CEORT commissioned a detailed legal analysis of nearly 80 clinical trial agreements. The review revealed substantial convergence—exceeding 67%—across key legal categories, demonstrating that standardization was both feasible and capable of improving consistency without compromising institutional autonomy.
Six Core Agreement Areas
1
Intellectual Property
Standardized language for ownership and licensing of inventions arising from clinical trials, with special considerations for investigator-initiated studies
2
Study Data
Clear terms for data collection, sharing, and analysis responsibilities between sponsors and investigators
3
Indemnification
Balanced approach to risk allocation between research institutions and pharmaceutical sponsors
4
Subject Injury
Guidelines for managing and compensating trial-related injuries to ensure participant protection
5
Confidentiality
Standardized provisions for protecting proprietary information while enabling necessary information exchange
6
Publication Rights
Framework balancing academic freedom to publish with sponsor’s need to protect proprietary information
Participating Organizations
CEORT Life Sciences Consortium
- AstraZeneca
- Eli Lilly
- GSK
- J&J
- Novartis
- OSI Pharmaceuticals
- Pfizer
- Quintiles
- Sanofi-Aventis
- Schering-Plough (2009, Merck)
- Wyeth (2009, Pfizer)
NCI-designated Cancer Centers
- City of Hope
- Dana-Farber/Harvard
- Fox Chase
- Johns Hopkins
- Mayo Clinic
- MD Anderson
- Moffitt
- Roswell Park
- UNC Lineberger
- University of Arizona
- University of California, San Francisco
- University of Chicago
- University of Colorado
- University of Pittsburgh
Timeline
2005–2006
Program Conception
- CEORT identifies protracted CTA negotiations as systemic barrier
- CEORT Life Sciences Consortium and NCI begin discussions
- Scope defined to create harmonized, universally available contracting language
2007–2008
Legal Analysis & Formal Clause Development
- CEORT mobilizes 11 pharmaceutical companies and 14 NCI-designated Cancer Centers
- Redacted clinical trial agreements (~80 CTAs) collected for legal analysis
- Third-party legal experts identify convergence across six key domains
2008
Framework Finalization
- Initial START Clauses completed
- Broad internal reviews by legal and operational teams
- Clauses validated as voluntary, non-binding starting point for negotiations
2009
Public Introduction
- NCI formally publishes and introduces the START Clauses
- Positioned as national toolkit to streamline clinical trial contracting
- Emphasis on compatibility with company-sponsored and investigator-initiated trials
2010
Implementation
- NCI Cancer Centers and LSC member companies begin using START Clauses
- Shared learnings circulated among institutions and sponsors
- CEORT promotes awareness through presentations and peer collaboration
2011
Impact Evaluation
- NCI and CEORT conduct formal evaluation
- Results: 67% convergence in negotiated clauses, reduced timelines, strong acceptance as middle-ground framework
- Findings presented at ASCO and published in Journal of Clinical Oncology
Impact Assessment
Key findings from 2011 evaluation:
Comprehensive Methodology
Analysis examined 78 CTAs from 11 pharmaceutical companies and 14 NCI-designated Cancer Centers, focusing on 6 key clause areas that traditionally caused negotiation delays
High Convergence Rate
Analysis identified 45 clause concepts with high convergence rates—exceeding 67% similarity—validating the premise that standardization can optimize and even eliminate duplicated effort in contractual negotiations
Decreased Negotiation Time
Stakeholders reported that CTA negotiation duration had decreased since the 2008 release of the START Clauses, with model language accepted as a practical compromise
By offering pre-negotiated, vetted language for common legal terms, the START Clauses enabled faster alignment among stakeholders and contributed to more predictable trial startup timelines.
START Clauses 2.0: A Modular Toolkit for Modern Oncology
Building on the original framework’s success, CEORT is launching START Clauses 2.0—a modular, next-generation framework addressing the growing complexity of modern oncology trials. New modules cover key friction points such as CRO management, biospecimen governance, platform trial structures, digital health integration, AI-driven endpoints, and global data privacy compliance.
New Modules
Why it matters: Biospecimens are central to precision oncology and long-term translational research, therefore, managing consent, storage, and future use introduces significant contractual complexity.
What it covers: Standardized contractual clauses applicable for biobanking, genomic data use, specimen tracking, and reconsent procedures.
Why it matters: Contract Research Organizations (CROs) play an integral role in clinical trial execution, yet their involvement often complicates liability and oversight structures.
What it covers: Templates for three-way agreements between sponsors, institutions, and CROs—including responsibilities, indemnification, and data handling.
Why it matters: Adaptive clinical trials with multiple study arms and sponsors raise challenges around shared infrastructure, amendment management, and IP ownership.
What it covers: Governance language for platform protocols, joint sponsor agreements, amendment workflows, and shared data/IP usage.
Why it matters: Remote monitoring, wearable devices, and eConsent platforms are increasingly integral to trial design, yet existing contracts rarely account for them.
What it covers: Legal clauses relevant to device performance standards, patient-generated data, cloud-based workflows, and digital privacy compliance.
Why it matters: AI-driven endpoints, diagnostics, and decision tools are introducing unprecedented complexity in terms of validation, explainability, and ownership.
What it covers: Clauses for algorithm validation, retraining protocols, regulatory disclosure, and IP rights over AI-generated insights.
Why it matters: Trials that incorporate RWD or real-world evidence (RWE) face uncertainty around ownership, reuse, and integration across sources.
What it covers: Standardized legal terms applicable for linking external datasets, managing reuse rights, and defining permissible analytics.
Why it matters: With adoption of more decentralized trials and inclusion of global patient populations, navigating data localization laws and privacy compliance is increasingly difficult.
What it covers: Data handling terms aligned with HIPAA, GDPR, and other relevant laws, including transfer protocols, encryption standards, and re-identification safeguards.
Why it matters: Cross-border clinical trials often face conflicting legal norms on indemnity, insurance, IP, and data protection, often stalling contract finalization.
What it covers: Contractual language aligned with major international regulatory frameworks (e.g., GDPR, ICH, EMA) to support multinational trial deployment.
Implementation Plan
Phase 1 (Year 1)
Coalition building and legal analysis
Phase 2 (Year 2)
Framework finalization and public introduction
Phase 3 (Years 3–5)
Monitoring and formal assessment
The Imperative for START 2.0
Context from 2025 J.P. Morgan Healthcare Conference:
“Our system is fragmented. Sponsors must negotiate every single trial and every single cost with every single site.”
Ashley Magargee CEO, Genentech
“Accelerating every stage—from enrollment and review to approvals and access—is essential for efficiency,” emphasizing that modern systems must be “innovative, scalable, and operationally sound.”
Bob Bradway Chairman & CEO, Amgen; CEORT Director Emeritus
“Clinical trials may have strong business cases, but success depends on the infrastructure to deliver.”
Karen Knudsen CEO, Parker Institute for Cancer Immunotherapy
Get Involved
We invite your organization to actively contribute to the design and implementation of START Clauses 2.0. Participating organizations will help shape clause content, participate in working groups, pilot modules in live settings, and guide the evolution of a shared legal resource that reduces inefficiency and improves consistency across clinical trial operations.
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