Pain studies can be complex; our experts have experience in a variety of pain and central nervous system (CNS) trials, so we can help you overcome the challenges.
Pain is the leading cause of disability worldwide, and the most common reason for people to seek care, according to research. Pain is also a huge growth area for clinical trials, including trials of alternatives to opioids, such as cannabinoids.
Studies that aim to help people living with pain can be complex, particularly due to the additional burden a clinical trial can put on patients. If the drug on trial is a restricted medicine or comes with a risk of addiction, there may be challenges around compliance with special regulations and site requirements.
What’s more, since there are often no relevant biomarkers, it can be difficult to select an objective endpoint for the study, and monitoring can involve Electronic Patient Reported Outcome (ePRO) and large volumes of questionnaires.
Having the right third-party vendors is key. At Excelya, we have extensive experience across a vast number of pain-related studies with different endpoints. Our experts know how to ensure your pain study runs smoothly for the best outcome for everyone involved.
Patients living with pain conditions may need special consideration throughout the clinical trial process. Given the physical and psychological impacts pain can have, patients may already be in a vulnerable state. They may face mobility and mental obstacles in adhering to the study’s requirements, increasing the risk of drop-outs, especially in placebo-controlled trials.
There are several types of pain, with various causes, including:
• Acute pain – short in duration, can be due to injury
• Chronic pain – can be part of a chronic condition, e.g. arthritis, fibromyalgia
• Neuropathic pain – due to damage to the nervous system
• Nociceptive pain – acute or chronic, caused by damage to body tissue
• Radicular pain – compression or inflammation of the spinal nerve, e.g. sciatica
At Excelya, we put people first. We have worked across acute and chronic pain trials, and we understand the importance of engaging patients and minimizing any additional burden on all those involved.
We work with you to take particular care during recruitment and enrolment, ensuring your trial adheres to the protocol and remains compliant. We also approach the study from the patient’s perspective, helping you meet your recruitment and retention goals.
Pain is often a symptom of neurological diseases, which are growing rapidly in prevalence, particularly among aging populations. In 2019, a reported 10 million people died and 349 million disability-adjusted life years (DALYs) were lost globally as a result of neurological diseases.
We have extensive experience with trials for various chronic conditions that include the use of pain measurements and scales. When we work on central nervous system (CNS) research, we only recruit experienced and dedicated people who understand the challenges you may face during the study. Whatever phase your clinical research is in, we can identify any issues and help you optimize your study.
We can also help get your trial back on track: we have experience rescuing failing studies, including adjusting recruitment strategies, changing processes to ensure protocol compliance, and taking on-site management.
Complex clinical trials require effective teams that work seamlessly. When you work with Excelya, our experts support your pain or CNS trial as an extension of your team, keeping the lines of communication short and processes efficient.
Your goals take the lead: we begin by talking about your expectations in terms of time and budget and discuss how we can best support your needs.
We work together closely and manage the project in a way that adapts to any changing circumstances while meeting your goals.
We focus on quality throughout our collaboration to ensure your study remains compliant and results in the best possible outcomes.
Our people-centered approach extends beyond the immediate project teams and participants to our broader Key Opinion Leader (KOL) networks. When you work with Excelya, you build strong connections that support your trial from start to finish.
