Neurology clinical trials are highly complex. ClinFocus’s team uses the following key considerations, along with extensive industry expertise, to successfully manage and monitor neurology trials for our clients.
1) Understanding of neurological pathologies and neurological assessments
More than just therapeutic experience, partnering with a team that has a whole picture understanding of neurological conditions, clinical assessments, IP administration and how they all relate can help add valuable insight to a study. This requires an understanding of the subject’s potential reactions to clinical assessments and their relation to adverse events.
For example:
- Does the study condition present with hypersensitivity (such as MS or Lupus)? How may this impact reactions to IP administered through injection?
- How may patients with cognitive disorders react to imaging – like being placed in an MRI?
- Does your study require blinded or unblinded raters for subjective assessments?
2) Ability to ensure the right resources & expertise to facilitate the flow of study information
Neurology studies, like many others, are often highly complex and may have vast amounts of study information and study partners involved. Is your neurology CRO able to properly facilitate this flow of information?
At ClinFocus, we target appropriate vendors and high performing sites, and we ensure an adequate amount of time is committed to set up. We use repeated testing to ensure everything works as it should. We also assign study team members who can dedicate time just to ensuring the flow of information is uninterrupted, with the ability to react to a changing environment, if needed.
3) Selecting and managing qualified, experienced vendors
The proper vetting, onboarding, and management of any additional teammates a study may need is critical. Through the use of a best-in-class model, sponsors can ensure that the right vendors – the most qualified, cost-efficient, and experienced – are selected for the job. These teammates are typically specialized experts in what they do, and help define clinical endpoints in neurological studies.
4) Considerations of a mindful collection of patient reported outcomes (PROs)
Pain, quality of life, and impact on daily activities are all patient reported outcomes that are nearly universal to neurology studies.
Neurological conditions impact how you perceive and experience sensations such as pain, sense of small, vision, etc. With such a reliance on PROs, it’s important to thoughtfully consider the best way to collect data. Consider the patient population: are electronic or paper PROs going to be the best approach for your specific study?
