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Posted On: 08/23/2024 11:56:34 AM
Post# of 148863
Cytodyn may well be engaging Syneos for the CRC study also and we just don’t know it yet. While you want a top flight CRO for both studies there is an overlay with disease state and the healthcare entities that the CRO already has a working relationship with that should be factored into the CRO contract decision. Large healthcare systems with equally large dedicated Oncology services will likely have dedicated teams to support the studies, an investigational pharmacy department hardwired to accept/store/distribute investigational drugs and an IRB in place to make the process engineered to flow smoothly, and quickly. It may DrJ has a preferred clinical site(s) where there may be a history of professional collaboration but Syneos is not already engaged with that organization even though Syneos does support oncology studies.
I would also note that the CRC study, focused on the MSS sub population for which there are a paucity of treatments, is highly likely to enroll quickly. I suspect the HIV inflammation study is also going to enroll quickly as there are know dedicated treatment centers that act likely magnets for the target population. What Cytodyn wants to avoid is a situation where the CRO has to engage in a large number of healthcare entities to get the study population enrolled. Each site needs a principal investigator assigned, staff trained on the protocol, an approved budget for the study for which the Cytodyn/CRO agree what they will be paying for (labs, drug staff compensation etc), and an IRB to approve the protocol/patient consent. Accordingly there is time friction added for each study site. Given that enrollment will likely be rapid (there are not a lot of treatments competing for either of these studies, very unlike the Cytodyn severe/critical COVID study that took forever to enroll because remdesivir et al were taking up all the oxygen in the treatment study space), the better part of wisdom is fewer study sites THAT ARE WELL RECOGNIZED for treating the population, the sooner results are in flight. If Syneos is connected to a treatment center/principal investigator Dr J has in mind, it could be Syneos, just pointing out there are legitimate reason another may be preferred.
I would also note that the CRC study, focused on the MSS sub population for which there are a paucity of treatments, is highly likely to enroll quickly. I suspect the HIV inflammation study is also going to enroll quickly as there are know dedicated treatment centers that act likely magnets for the target population. What Cytodyn wants to avoid is a situation where the CRO has to engage in a large number of healthcare entities to get the study population enrolled. Each site needs a principal investigator assigned, staff trained on the protocol, an approved budget for the study for which the Cytodyn/CRO agree what they will be paying for (labs, drug staff compensation etc), and an IRB to approve the protocol/patient consent. Accordingly there is time friction added for each study site. Given that enrollment will likely be rapid (there are not a lot of treatments competing for either of these studies, very unlike the Cytodyn severe/critical COVID study that took forever to enroll because remdesivir et al were taking up all the oxygen in the treatment study space), the better part of wisdom is fewer study sites THAT ARE WELL RECOGNIZED for treating the population, the sooner results are in flight. If Syneos is connected to a treatment center/principal investigator Dr J has in mind, it could be Syneos, just pointing out there are legitimate reason another may be preferred.
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