As part of the investigator team, long before you even start thinking about your looming recruitment window, you have various regulatory processes to complete with the trial sponsor.
The study set-up phase can be a long process. You will almost constantly be in a 3-way conversation with the study sponsor and the local R&D department. One of the first meetings you will have with the trial sponsor is a feasibility assessment meeting. The purpose of this meeting is to ensure that any potential barriers to the study being successful are discussed. This can include, for example, whether or not the inclusion/exclusion criteria is to too restrictive, if the recruitment target realistic, etc. Furthermore, the feasibility meeting is the time when you will discuss the ability of the unit to run the trial effectively. Typical points of discussion are: staff experience of the disease area, available patient population, conflicting studies within the unit, facilities, and budget negotiations.
Once these issues have been hashed out, the next task is to apply for ethics approval and clinical trial authorisation. You will need all the trial documents available to you from the trial manager so that they can be sent away for ethical approval. Every document that is to be used for the trial (i.e. consent forms and participant information sheets) must have ethical approval from the hospitals R&D department before it is used as part of the trial.
Typically, the next time I will meet the sponsor/trial manager will be the SIV (site initiation visit). The purpose of this meeting is to discuss the protocol. Do I envisage any problems? Is there any specialist equipment that I need to be trained on? Who needs to be on the delegation log? Currently, I am working on some studies researching respiratory diseases, and although you learn the protocol and the inclusion/exclusion criteria, sometimes minor issues can arise, so it’s a great help to have a trial manager who is approachable and efficient. The trial manager is the go-to person if any issues present themselves, so a good working relationship is vital.
There are also challenges to overcome with your trial manager, specifically around implementing amendments. Amendments can be slow to put into practice, which can be frustrating for sponsors. Any amendment that the sponsor makes must not only be approved by the competent authority, but also by the hospital ethics department. Just because the competent authority deems it an acceptable amendment, doesn’t mean the ethics department agrees. So as a trial manager you may receive emails from the sponsor authorising you to use the new amendment but it is not possible to do so until it is locally approved.
Despite the frequent monitoring visits, phone calls and emails from the sponsor, let’s not forget we are all working towards the same goal. That’s to run an ethically sound clinical trial.
