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


Figure 4
Of course the processes and tools will only work if the parties involved are properly trained. The training should also include good communication guidelines and skills; the lack of proper communication is considered as a bottleneck in the contract management process by the respondents of the survey (33%) (Figure 4).

In order to evaluate the processes and identify bottlenecks and stagnations in the process it is important to track the progress of the negotiation. There are many reasons why delays occur, and many of them can be avoided if the cause of the delay is known. Lack of clarity on who is responsible to move things forward at a certain stage, too high a workload of the parties responsible for the negotiation process, or a contract slipping through the net can all create delays, but if identified in time while tracking the progress and followed-up by the correct action, it will be possible to minimize the consequential delays. Keeping metrics of the turn-around times can also assist with setting the right expectations with the different parties involved, and help with realistic planning.


Figure 5
Apparently, however, many companies do not have an official, solidly working tracking system or follow-up processes in place. The survey shows that most of the respondents are not using an official tracking system but are using simple methodology such as an Excel sheet. Not quite half of the respondents indicated that they keep metrics on turn-around times. There is obviously still room for improvement in this area (Figure 5).

Country and site selection. A large treatment-naïve patient population, a well-organized health system, low costs, the availability of certain key opinion leaders, and other factors influence the decision to select a country to participate in a clinical trial. From the survey it appears that troublesome contract negotiations can also be made part of that list: 30% of the respondents indicate it can influence their decision not to select a country.

It is important for the decision maker to know the actual reason for difficult negotiations in that country. It could be the case that the staff dealing with these agreements are simply not familiar enough with the local laws, regulations, and practices. Countries that are perceived as most "difficult" by the respondents of the survey are the United States, France, Spain, Italy, Russia, and Poland. The European countries listed are typically countries where one could save valuable time were familiar with the local requirements. In such cases, it is worthwhile to ensure proper training of contract management staff, so that the decision to select a country can be based on other factors that are more difficult to influence.

Demanding country-specific procedures, laws, and regulations, or bureaucracy at the sites are harder to avoid. In such cases, it might be interesting for local organizations that promote clinical research in their country to use their influence in order to help adjust local laws and regulations, to stimulate more efficient local procedures, and to facilitate education and support of the relevant site staff and/or investigators.


Figure 6
When selecting sites, a vast majority of the respondents (80%) state that previous bad experience with the contract negotiations at the site influences their decision to work with that site in the future. There can be reasons to select a site despite a poor reputation with respect to contract negotiation timelines, for instance the availability of a key opinion leader, but the results of the survey imply that timelines are eventually a major decisive factor (Figure 6).


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