By Caroline Thangavelu
Have you ever come across clinical trial agreements that look like walls of text? You struggle through clauses written with multiple negatives within a paragraph or language containing archaisms and technical legal terms that no businessperson will understand. Did you feel “invited” to read on? Did you jump on the agreement and review it right away?
Chances are, most of us will feel like we are entering into a counterintuitive world when faced with such agreements. It does not help that our attention span has gotten shorter over the years.1 Contract simplification can bridge the distance between a clinical trial agreement and the reader or reviewer.
What Is Contract Simplification?
Contract simplification means different things to different parties.
For some, it means an agreement that a high schooler could readily understand without context or explanation.2 For others, contract simplification goes beyond the text of the agreement. For example, the International Association for Contract & Commercial Management (IACCM) analyzes agreement templates by considering the language, design, content, and how far the agreement fosters a positive relationship and sense of colloboration.3
This article considers contract simplification holistically.
A contract is simple when it uses modern, everyday business English free of unnecessary technical and legal jargon. Its content is balanced and relevant. There is a clear structure with organized paragraphs. To aid its readability, the contract drafter uses visual aids such as tables and flowcharts.
You may reduce the size of your clinical trial agreement, but a short agreement is not the goal here. Clarity and accessibility are.
Three Reasons To Explore Clinical Trial Agreement Simplification
Industry players are consistently looking for solutions to speed up clinical trial agreement finalization. Typical solutions include setting up master clinical trial agreements, streamlining communication processes, and using preferred clinical trial sites.
Contract simplification is another territory for innovative players to explore.
Here are three reasons you should simplify your clinical trial agreement to improve your clinical trial agreement performance.
1. Enhance Communication
Simplification takes away some challenges that come with the lack of standard interpretive frames in communication.
The global nature of clinical trial projects means that organizations work with contract reviewers coming from different language and cultural backgrounds. It is also commonplace for organizations within the industry to have contracting staff with or without legal experience working on the clinical trial agreements. Contract reviewers may also vary in terms of work experience with clinical trial agreements.
Given these dynamics, simplifying your clinical trial agreement will help contract reviewers, regardless of their background and profile, to negotiate with ease. A simple and clear clinical trial agreement aids understanding of the deal. Contract reviewers will get to the substance with less delay and confusion. Potential misunderstandings are limited.
On the other side, a wordy, long-winded agreement with traditional contract language breeds ambiguity. It makes clinical trial agreement review and negotiations unnecessarily long and complicated. This unfavorable outcome is especially relevant in an environment where there are subtleties and differences in language, communication, and profile of the negotiators. In seeking understanding, negotiations go back and forth, resulting in undesired protracted timelines.
This challenge is often further exacerbated when organizations need to translate the clinical trial agreements into local languages. A complexly worded and poorly structured document makes translation cumbersome and increases the costs manifold. And, we have yet to unearth the outcome that a poorly translated agreement brings with it!
2. Aid Negotiations
A balanced, clear, readable, and structured first draft makes clinical trial agreement negotiation accessible and builds trust.
Your clinical trial agreement triggers an immediate emotional response when your counterparty reads or reviews it. You set the tone for negotiations through the first draft you send to the clinical sites.
A dense, illegible agreement leaning heavily toward your interests encourages the counterparty to delay or procrastinate the review process. You stimulate over-scrutinization when the reviewer must second-guess the contents of the clinical trial agreement. The clinical trial agreement will also likely end up in the next level of the review chain. Review and negotiation time is prolonged.
Contrarily, we maximize the benefit of a win-win negotiation when a clinical trial agreement is clear, structured, and seeks to promote the common interests of the parties.
Review of clinical trial agreements goes more quickly when the reviewers understand the contents, with confidence. Reviewers also give better input and comments that will improve the substance of the deal. A more satisfying long-term relationship follows.
3. Create A Foundation For Contract Automation
Contract automation can reduce time spent on clinical trial agreement drafting.
To automate contracts, clarity, relevance, consistency, and structure across your contract template are essential.
Contract simplification can help you set this foundation for your clinical trial agreement automation project.
An unambiguous and organized clinical trial agreement template gives you quick access to better and reliable data for the coding of the repeated elements of your clinical trial agreement. A vague model agreement filled with disorganized clauses requires workarounds during contract automation. Grouping key variable items such as the operational, financial, and legal terms together makes management of the contract automation process more practicable and organized.
Besides, a clear template helps the party automating the clinical trial agreement to come up with the right guide or questionnaire for the end users to walk through the template creation process.
It is also more straightforward to set up a contract library clause when the contract terms used are consistent and do not resemble a byproduct of a copy and paste exercise.
What Can You Do Next?
Section 5.9 of the International Council for Harmonization (ICH) efficacy guideline on good clinical practices (GCP) E6(R2) 4 requires documentation of the financial aspects of the clinical trial in an agreement. But beyond that, your clinical trial agreement is a structured communication. It sets out the actionable items and reconciles the parties’ expectations in conducting the clinical trial.
Design your clinical trial agreement to speak about what matters most to you — your clinical research — and in a tone of voice that inspires collaboration. Your clinical trial agreement is more than another document you need to put in place before your clinical trial can start. It is more than a legal document. It represents you and what you stand for.
- Jensen, T. V. (2019, April 15). Abundance of Information Narrows Our Collective Attention Span. Technical University of Denmark. Retrieved from https://www.dtu.dk/english/news/2019/04/abundance-of-information-narrows-our-collective-attention-span?id=246bbed3-8683-4012-a294-20db7f0015f4
- Burton, S. (2018, Jan-Feb). The Case for Plain-Language Contracts. Harvard Business Review. Retrieved from https://hbr.org/2018/01/the-case-for-plain-language-contracts
- IACCM. Contract Design and Simplification. Retrieved from: https://www.iaccm.com/services/contract-design-and-simplification/
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2016, November 9). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6 (R2). Retrieved from: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
About The Author:
Caroline Thangavelu is a freelance clinical trial contract consultant based in Amsterdam, the Netherlands. She helps small and midsize companies to streamline their clinical contract operations and develop their contract specialists. Her more than one decade of experience in consulting and providing strategic direction to clinical trial contracts spans over 50 countries worldwide. You can reach Caroline at firstname.lastname@example.org or connect with her on LinkedIn.