Hospital single contract: real benefit to the French clinical research?
A hospital single contract between the promoter and public hospitals was set up by the Ministry of Health. What will be the impact for the CRA, SSC and investigators?
1. Hospital single contract, what is it?
It refers only to industrial clinical trials (drug, medical device and diagnostic) conducted in public health facilities. This contract combines the industrial promoter, the health institution, and the investigator for one location of research. It necessarily includes, on a single contract, fees of the investigator, of those dedicated to research staff and hospital additional costs.
First, it is established between the hospital of the coordinating investigator (« coordinating institution ») and the promoter; then it is duplicated identically for all health institutions involved in the research (« associated facilities »).
2. Hospital single contract, what interest?
This contract has several advantages:
- The deadline is 45 days for negotiations with the coordinating institution, then 15 days with the associated centers. Before, the deadline could be up to 4 months for contract signing with the coordinating institution. So, the period is considerably reduced.
- A single contract between the promoter, the health institution, and the investigator. Before, there could be contracts for cardiologists, radiologists, biologists, associations. Negotiations were carried out with every actor … In short; it reduces the number of contracts to be negotiated by the center.
- The same contract and the same additional costs grid will be used for all participating public hospitals. Before, we had to renegotiate certain points of the contract with the other hospitals. Now we save time on this stage (it will take 15 days to sign).
- Conventions and grids are available on the Health Ministry website. Depending on the duration of the study and its complexity, there are types of packages offered. All that needs to be done is adapting the grids to study. Before, negotiations were more complex because there was no base reference. Today we have a basis of calculation, everything is easier 😉
- The agreements will be signed before obtaining regulatory approvals. Before, some hospitals refused to sign as long as we did not have the permissions. Of course before starting the setting visits, permissions are necessary.
- Promoter submission to the Medical Association National Council is no longer required before signing the agreement. However, doctors must always notify the signature of this agreement to the Medical Association Departmental Council (DCMA). Before, all contracts including contracts with hospitals involving investigators were to be submitted to NCMA (tacit authorization within 2 months). Now this makes us a regulatory submission in less.
- Hospitals that use only the single contract will receive public funds to be used for innovation. These funds will supply clinical research in the services (hopefully!). This will motivate hospitals to use this contract.
With this new mechanism, patients can benefit more quickly from innovative treatments and French physicians can begin inclusions within a fewer time. Our investigators will no longer be left behind other countries.
3. Our skepticism about the single contract
Associations created by investigators allows in some establishments clinical research and training dedicated team development. Will Clinical research technician Jobs created by these associations be in danger?
Finally, the investigators lose their direct fees since these are repaid to hospitals. What is the impact on their motivation? The law provides an optional « financial incentive » in the single contract. This incentive can be repaid for each inclusion or on the objectives achievement. It aims to be repaid to the medical center of the investigator. Would that be the case?
The hospital single contract is a good way to shorten the pre-contracts signature period. Fewer interlocutors and fewer round-trip for negotiations will facilitate CRAs work. It will increase the France competitiveness and will revive the French clinical research, provided that all the funds are transferred to the investigator’s service to maintain or create jobs of Study Coordinator within the hospital (These are essential to the conduct of clinical trials).
And you, what do you think of the single contract? Give us your opinion.
Do you have any question?
See you soon,
Sophie Hammer
I am Pharmaspecific Clinical Research Associate and Project Manager for 2 years.
Sources :
The statement on the official website of the Health Ministry.
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