Delays caused by clinical trial agreements are, unfortunately, nothing new and have been in the spotlight for a couple of years now. In 2017, Molly Huggins JD, in her article entitled “Budget, Contract Negotiations Greatest Causes of Clinical Trial Delays, New Report Shows ” pointed out that 63% of the respondents from large sites to a collaborative survey conducted by CenterWatch-ACRP in 2016 cited contract negotiations as the top roadblock and, 54% echoed that at small sites. (Huggins, 2017) This remains to be the case as companies continue to strive to improve clinical trial agreement cycle times by leveraging processes, site relationships, technology and knowledge management, all of them being important aspects to be considered in the reduction of clinical trial agreement cycle time.
However, have you ever asked yourself if the design of your clinical trial agreement will further help you positively influence your clinical trial agreement cycle time?
I have. In fact, this is one of the first few things that caught my attention in the early days of my professional career in the clinical trial agreement business.
I have come across long, legalese written agreements, poorly structured agreements where the definitions and contents are inconsistent and, agreements that look like the clauses have been copied and pasted from several different documents. Even with my trained eyes, I have found the review of the agreements to be tedious, and it took me numerous rounds of back and forth to tease out the real meaning and effect of the agreements! Can you imagine the effect of such agreements when translated into foreign languages or when the party on the other end may not have English as their first language?
I am here to suggest that balanced clinical trial agreements, drafted using business English can further contribute to faster negotiations. Here are two main reasons for this suggestion:
- It is easier for the people working with the clinical trial agreements to understand what they are negotiating and signing up for. A fair number of clinical trial agreement specialists or managers, whether at the sponsor, Contract Research Organization or site level does not have legal background. The make-up of the profile of a clinical trial agreement manager or site contract specialist is mixed. You have staff with science and business background in the role and in some jurisdictions or organizations, the Clinical Research Associate is responsible for negotiating the clinical trial agreements. A balanced, comprehensible and accessible clinical trial agreement can smoothen and shorten the negotiations process as the parties can avoid spending a lot of time ploughing through and trying to decipher complex or convoluted terms and sentence structures. This enables them to negotiate and finalize clinical trial agreements more effectively and quickly as they understand the contents of the agreement and can focus on coming to an acceptable agreement.
- Translations become easier to handle and negotiations in local language become more manageable. Those with experience in multinational trials will know that the various legal systems will bring with them various legal terms and concepts, and this, coupled with the input of different translators worldwide may result in complex English terms being translated into something that does not bear any resemblance to their original meaning. You can avoid terms being lost in translation and, avoid ending up with terms that do not make sense in local language when you use clear, comprehensible language. This takes away unnecessary negotiations hurdles caused by translation.
If you are thinking about what you can do to design balanced, comprehensible clinical trial agreements, incorporate these 10 tips into your drafting process:
- Use clear, business like language – language that is direct, informative and readable. In other words, language that clearly states the terms of the deal.
- Be reasonable about the terms of the deal and focus on a win-win solution. Agreements for every clinical trial are different depending on, for example, the type of trial, the stage of the trial, the risk appetite of the parties involved and the location of the trial.
- Keep the provisions readable and clear by reducing the average sentence length.
- Avoid foreign terms like “bona fide” or “inter alia” or archaic language like “henceforth” or “witnesseth.”
- Avoid using the contrived conjunction “and/or”. Clarity and being direct are key. If you want the reader to understand your message, be clear. Don’t sit on the fence.
- Avoid too many double negatives. Spare the mental gymnastics for another occasion!
- Avoid awkward sentences containing numerous semicolons.
- Use headings – they are signposts for the reader.
- Use a generous type size and appropriate letter font.
- Use numbering systems and lists. Complement your agreement using user-friendly layout or design.
Be reasonable and clear. This is how you level up your clinical trial agreement negotiations.
References:
- Molly Huggins JD. (2019). Budget, Contract Negotiations Greatest Causes of Clinical Trial Delays, New Report Shows. Retrieved from https://acrpnet.org/2017/01/26/contract-negotiations-greatest-cause-clinical-trial-delays-new-report-shows/
