Clinical Trial Agreement Negotiations

There are opportunities to make the negotiation process more efficient and reduce timelines
Jun 01, 2012
By Applied Clinical Trials Editors
Volume 21, Issue 6

Communication with the sites. The results of the survey show that the general perception in the industry is that hospitals or investigators participating in a clinical trial often cause delays in the contract negotiation process due to rigid hospital lawyers and a lack of a sense of urgency at the site. The industry perceives turn-around times to be unnecessarily long.

Bureaucracy and lack of understanding are difficult to avoid; however, there are still ways to influence the progress of the negotiations. Setting deadlines with the sites seems self-evident, but is often not done. Another way to speed up the process is to provide a solid explanation and background information on difficult topics to clinical sites. If necessary, instead of a member of the clinical team trying to negotiate with the site on the basis of comments of the lawyer or contract manager, the latter could get in touch with the site directly to solve any outstanding items.

Training, education, and creating awareness both at the site and with the contract managers could in the long term contribute to a solution for this delaying factor.

If at the beginning of a negotiation the topics that are usually difficult to negotiate are known, it provides the opportunity to anticipate and pre-empt such problems. Suggesting clear and fair language and providing additional explanation on difficult or sensitive topics can make a difference. According to the outcome of the survey, the most difficult topics to negotiate in site agreements are terms relating to budget and payment, intellectual property and inventions, indemnification and liability, publication, insurance, and applicable law and jurisdiction.

Not only can the sites find clauses on these topics difficult to deal with, also contract managers without a thorough legal background or sufficient experience find these topics challenging to negotiate. Training on these specific topics would help staff draft clear and more acceptable clauses, understand them, and explain the language and its rationale to the site.

Templates. The template, as a starting point of the negotiations, can have a tremendous influence on the speed and success of the negotiation process. A complicated and unclear template makes hospitals and investigators suspicious of what they are asked to sign and will create a reluctance to review the agreement and to agree on the terms. A well-structured, straight-forward template on the other hand, will inspire confidence and trust with the hospitals and investigators. This obviously will help speed up the process of getting the contracts agreed and signed.

For a sponsor of a clinical trial it might also be interesting to know whether it will be more (time and cost) efficient to use its own standard templates or the templates of the CRO that it has contracted to perform the trial and that is actually responsible for the negotiations of the agreements. A sponsor may benefit from using its own templates if it has conducted previous studies with the involved sites on the basis of the same template and, moreover, coming from the "sponsor," the templates may be more easily acceptable, due to increased authoritative value. In addition, for a large organization it is helpful to achieve some consistency in the documents that are signed with other parties, for better oversight and control. On the other hand, it could also be efficient to let the CRO use the template that it is familiar with, so that it will be easier and consequentially faster for it to negotiate the terms. Either way, there are disadvantages and benefits; eventually, the quality and suitability of the template may have a greater impact on acceptability than the party providing it.

Another option that is often suggested to save negotiation time is the standardization of the clinical trial agreement template. Respondents of the survey also indicated this as an important solution for cumbersome contract negotiations. In some countries, like the United Kingdom, the involved interest groups successfully introduced a standardized template for clinical trial agreements. The reason why it seems to work in the United Kingdom is that:

  • The template is created jointly by the representatives of the parties involved in clinical research, which creates a solid basis for acceptance of the terms
  • The template is of high quality
  • Room is left for flexibility

If approached in the same way as in the United Kingdom, a standardized country-specific template can facilitate negotiations. However, a worldwide or continent-wide standard template will be difficult to achieve, since there will be too many local differences to overcome.

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