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Each pain model presented below has its own complexities and nuances. Although the populations are unified because they are all associated with pain syndromes, the pathologies are very different and as such the patient populations are unique. That being the case, each model requires a tailored approach. For example, recruitment of a population of patients that have post-herpetic neuralgia requires a completely different strategy than accrual of patients into a total knee replacement study. The same argument holds true for patient retention, clinical management and data collection. Presented below is a list of specific pain models that Lotus has had hands-on experience with.
Lotus Clinical Research has extensive experience with the following pain models:
By utilizing our Acute Pain Recruited Surgical Model, Lotus decreases enrollment time and reduces overall project cost substantially. Instead of recruiting acute pain patients in the conventional way, waiting for patients who have the condition of interest to present themselves to the hospital for surgery, Lotus actively recruits patients using newspaper, radio and television advertisements. Our location within a large metropolitan hospital gives us the ability to apply this model to multiple surgical indications and enroll an average of 8-10 patients per week. Project costs can be reduced by 30+% over a larger multicenter trial as a result of; less time for investigator recruitment and training, CRA travel, project management, etc.
Lotus specializes in early phase proof of concept chronic pain studies. Many sponsors do not realize how much information can be garnered from early phase studies. A properly designed patient based early phase chronic pain study should not only provide a read on safety, but can also reveal pharmacokinetic profiles, efficacy information and dose response trends. We can recruit and house chronic pain populations so that PK can be collected and efficacy measurements can be made while the patient remains housed/domiciled in the Lotus facility. In addition, Lotus has specialized capabilities like CSF sampling and PET scanning and fMRI.
Lotus is the nation's top enrolling site into opioid induced constipation studies. We have a mature database of over 12,000 chronic pain volunteers and have successfully completed numerous OIC investigations (both early and late phase). We can provide advice regarding expected run-in failure rates based on study specific I/E criteria, subject diary reconciliation and gastrointestinal adverse event adjudication. Another form of opioid related distress is postoperative nausea and vomiting. Lotus has published extensively in this area and has unique insights on how to enroll and standardized PONV protocols. Specifically, the use of 5HT antagonists has become commonplace in US hospitals and therefore PONV protocols that incorporate the use of rescue as a primary endpoint must enforce an algorithmic site rescue strategy. Lotus has designed and successfully implemented this type of strategy for previous Pharma clients.