Solving the opioid epidemic long-term requires bringing new, safe and better treatments to market to replace the reliance on opioids in the clinical setting. The development of a non-addictive, non-opioid treatment or an adjunct treatment that could reduce the needed opioid dosage would revolutionize how we treat pain. However, the industry is facing significant challenges in developing these therapies, including the weak ability of preclinical data to predict clinical success and insufficient financing. Both have led to high rates of program failure.
Despite the challenges, promising investigational products for pain management are entering into trials. The development partners these sponsors select will impact the quality of data and the success of the program, making it critical to work with a partner who has experience developing these products.
Worldwide Clinical Trials was founded over three decades ago to advance neuroscience compounds. While they have expanded to support many therapeutic areas, Worldwide built its name by delivering exceptional neuroscience development services in partnership with the sponsors leading the charge in changing medicine. Beyond traditional development services, Worldwide partners for program and sponsor success, offering consultative drug development services and assistance with securing the funding needed to advance pain programs.
In this Xtalks Spotlight feature, Xtalks spoke with Maria Madariaga, MD, Associate Medical Monitor, Neuroscience, Medical Affairs at Worldwide Clinical Trials. Dr. Madariaga discussed how the industry is working to overcome the challenges presented by opioids and where the industry is headed for pain management and treatment.
“It is estimated that about one-quarter of the global population lives in chronic constant debilitating pain,” said Dr. Madariaga, highlighting the seriousness of the issue.
With a career spanning two decades of clinical experience as a former pain-specialized anesthesiologist and investigator for pain clinical trials, Dr. Madariaga’s insights offer a valuable perspective on the current state and future of pain management.
Advancing Clinical Trials in Pain Management
Chronic pain management presents a substantial challenge in medical research and treatment. There is an urgent need for innovation in clinical trials for pain management. Dr. Madariaga highlighted the limitations of current placebo-controlled trials, noting the variability and inaccuracies arising from subjective pain measures.
“Placebo response is a major challenge in analgesic trials, often leading to false negative results. To solve this important hurdle, we need to understand how and why placebo response happens and employ techniques to reduce bias,” she explained.
This issue underscores the necessity for more precise and reliable data collection methods in these studies. To overcome these hurdles, a multi-faceted approach should be implemented. Understanding the placebo response and reducing biases from the study staff and patients are crucial first steps.
“We should work on finding new approaches that are different from the current analgesic drugs and devices.”
– Maria Madariaga
Additionally, exploring new analgesic compounds and targets is vital. Dr. Madariaga mentioned potential avenues like endogenous opioid receptor agonists, TRPV1 receptor agonists, dorsal root ganglia neuron targeting and cannabinoids. These innovative strategies could offer effective pain relief without the risks associated with traditional opioids.
Dr. Madariaga’s enthusiasm for these new directions was evident. “There are a lot of new strategies to achieve new objectives in pain clinical research, which these populations need,” she stated, stressing the importance of continuing clinical trials in these areas to meet the needs of the vast population suffering from chronic pain.
The Greatest Needs in Chronic Pain Management
Chronic pain conditions can be categorized into several types, each presenting unique complexities. Chronic primary pain, also known as neuroplastic pain, arises without a clear physical cause but involves changes in the nervous system. Chronic secondary pain, in contrast, is directly linked to a known physical condition.
A particularly challenging type is neuropathic pain, which develops due to lesions within the somatosensory nervous system. Pain associated with cancer and post-operative pain also fall into this category, requiring equally urgent attention. Furthermore, there is inflammatory or nociceptive mechanical degenerative pain, exemplified by conditions like osteoarthritis.
Dr. Madariaga emphasized that every chronic pain condition, without exception, is in dire need of advanced treatment methods. According to her, the need for better drugs spans the entire spectrum of pain conditions, from the initial nociception (the sensory nervous system’s response to harmful stimuli) to the altered brain function observed in chronic pain patients.
Individuals who become chronic pain patients often have a lifelong struggle, so it is crucial to develop novel, effective treatments for these conditions.
Understanding Nociplastic Pain
Nociplastic pain is a relatively new classification in chronic pain research. It represents a shift in understanding chronic pain conditions, distinguishing them from traditional categories like mechanical, nociceptive, or neuropathic pain.
The International Association for the Study of Pain (IASP) defines nociplastic pain as “pain that arises from altered nociception despite no clear evidence of actual or threatened tissue damage causing the activation of peripheral nociceptors or evidence for disease or lesion of the somatosensory system causing the pain.”
This reclassification is particularly relevant for conditions like fibromyalgia, characterized by symptoms such as fatigue, insomnia and depressed mood, which significantly impair a person’s ability to function and quality of life.
Dr. Madariaga emphasized that this new category implies many changes for patients. “It means that those who meet the classical criteria for other types of pain may find the best treatment options possible, as well as better clinical research opportunities regarding their symptoms,” she explained. This reclassification is a gateway to more tailored and effective treatments.
The new classification of nociplastic pain reflects a deeper understanding of chronic pain’s multifaceted nature. Recognizing it as a distinct category allows for more focused research and, ultimately, better patient outcomes.
Looking to the Future of Pain Management
The field of pain management has undergone significant advancements, and organizations like Worldwide Clinical Trials have been at the forefront of developing treatments, particularly in neuroscience and pain indications.
Dr. Madariaga accentuated the importance of a universal understanding of pain conditions, stating, “We must know what we are talking about well to compare different pain conditions in the best possible way. We must utilize chronic pain classification tools that allow the medical community to speak the same language.”
Therefore, education and research in pain science and pain medicine are pivotal, as they are crucial for enhancing the quality of life for patients suffering from pain.
“Effectively designing and executing clinical trials is crucial in pain studies to achieve better quality of life for our patients.”
– Maria Madariaga
In addition, clinical trials play a central role in improving pain management. There is also a need for sponsor support in advancing pain relief treatment without the risks previously associated with clinical trials in pain management.
Overall, Dr. Madariaga is optimistic about the potential of clinical trials to provide substantial scientific evidence for various novel interventions in pain management, including drugs and medical devices.
Worldwide’s Unique Approach to Clinical Trials in Pain Management
Emphasizing the importance of personalized development services, Dr. Madariaga highlighted Worldwide’s commitment to thorough preparation in every aspect of each clinical trial.
According to her, Worldwide’s distinction lies in its blend of a close client relationship, which is facilitated by its size, and its exceptional readiness for all trial aspects. This approach is vital in clinical trials for pain management, where individual patient needs and trial integrity are paramount.
The company’s name, ‘Worldwide Clinical Trials’, also reflects its diverse team, with each member bringing unique backgrounds and expertise. This diversity is instrumental in the company’s ability to handle various aspects of clinical trials effectively.
“We thoroughly prepare for every aspect of each clinical trial and maintain close contact with our sponsors. I’d say that our teamwork as a whole shines through in the clinical trial execution,” Dr. Madariaga added. Her insights shed light on how Worldwide’s approach not only aids in advancing trials in pain but also sets a new standard in the contract research organization (CRO) sector.
For more insights into advancing clinical trials for pain management, be sure to watch the Spotlight feature with Dr. Madariaga.
This article was created in collaboration with the sponsoring company and the Xtalks editorial team.