Important change on the EU clinical trial market is expected by 31 January 2022 - updated EU Clinical Trial Regulations will come into effect. According to the European Commission, the EU portal and the EU database fulfilled the conditions of full functionality, and the systems meet the required functional specifications to build up the unique Clinical Trials Information System (CTIS).
Negotiating Clinical Trial Agreements is not an easy task, especially when dealing with huge multi-center and multi-country study. A lot of key players are involved into the process: negotiators, Sponsor or CRO’s clinical and start-up teams, contract managers, legal advisors etc. It is essential to build up a clear and well-working communication paths between all stakeholders. Sounds self-evident, however the practice demonstrates that quite often the communication falters at some time point that leads to errors, misunderstandings, and delays in contract finalisation.
Clinical trial sites invest significant time and efforts to get prepared for the start of a clinical trial. Sites need to work on site-specific informed consent, collaborate with their Ethics Committees and/or Review Boards, perform submissions, review a lot of study documentation (protocol, investigator brochures, manuals etc.), attend trial-specific trainings and meetings, negotiate clinical trial agreements and budgets, and perform numerous of other actions before the trial actually starts.
How often do you face the situation when after clinical trial kick-off meeting you discover that section on the clinical trial agreement and site budget negotiation is just a couple of lines in the study project start-up plan, or is even missing? We bet it happens quite often. Then, when the absence of a fully executed CTA becomes a bottleneck for site activation, the project team starts to jump on the site contracts team´s head requiring to get the fully executed CTA right here and right now, that makes the working environment stressful for all: Sponsor, CRO, Site, and surely for the negotiators - all become literally anxious, and all the negotiation process becomes a ‘good’ sample of the anarchy.
2020-2021 have challenged the World with COVID-19 pandemic. This literally concerned everyone and made a huge impact on every sphere of people’s life. Clinical trials are not an exception. The global healthcare system focused on the fight against the coronavirus that required many hospitals switch to COVID-only regime resulting in slow-down of the start-up of clinical trials or even their cancellation.
Initiating a clinical trial Sponsors are focused on quick and smooth start-up, fast patient recruitment and successful trial conduct and completion. For this purpose, the Sponsors are trying to select the sites that are providing best-in-class healthcare services in the given region for the given nosology and have a big number of potential trial patients.
International clinical trials require international teams, and contract negotiation is not an exception. We rely a lot on the local negotiators’ expertise, since they are the ones who negotiate with the sites directly, aware of the current local practice, customs and legal requirements. Managing a team of local professionals can be quite a challenge since there are many actual and potential burdens that can jeopardize efficient team’s work. Here we will discuss some of these burdens and how to efficiently mitigate them.
Pay-when-paid model of clinical trial site payments is widely used in cases when conduct of a clinical trial is outsourced, fully or partially, to a CRO or specific service provider managing site payments in particular. Pay-when-paid model is the reality that often doesn’t depend on whether a clinical trial agreement (CTA) contains the corresponding wording or not, since according to the Good Clinical Practice, the Sponsor has the ultimate responsibility for financial aspects of the clinical trial and it is quite clear that the CRO can perform site payments after the corresponding funds are received from the Sponsor. So, is it really that important to keep pay-when-paid wording in the CTA?
Silence gives consent – wouldn’t that be perfect if this old saying were applicable to contract negotiation operations? How easy would that be just to send the clinical trial agreement to the site, wait for a couple of days or weeks, and start signature process. A fat chance! Silence in negotiations means a lot, but never something positive. Let’s see why the sites become silent and how to manage this silence.
It may sound posh, but a Clinical Trial Agreement’s (CTA) life looks pretty much as a human’s. CTA is born from the template, then its childhood period is filled with the site-specific adaptations ending up in a turbulent adolescence period of negotiation and execution. A grownup CTA becomes quite mature and self-sufficient, and often becoming cluttered with Amendments at some timepoints of its life. Here is where the allegory ends.