For hundreds of years, the medical community has known that the mere act of receiving treatment, even if it’s just a sugar pill, can improve a patient’s symptoms. Therefore, in order to ensure that the effects of an experimental treatment are real, most randomized controlled trials (RCTs) include a placebo arm. Placebos are most often...
Fibromyalgia is a chronic, complex pain condition characterized by widespread pain and a diverse range of symptomatic manifestations, including fatigue, sleep disturbance, dyscognition, diminished physical functioning, and mood disturbances. To date, patient-reported outcomes remain the best method for characterizing the many facets of fibromyalgia. Patient-reported outcomes are gaining traction as a highly effective option for...
Treating the chronic pain experienced by patients with osteoarthritis is among the most enduring challenges in analgesic drug development. Operationalizing trials for osteoarthritis of the knee requires careful consideration of study design, strategies for mitigating placebo response, and site selection. Osteoarthritis, sometimes called degenerative joint disease or degenerative arthritis, occurs when the protective cartilage on...
Recent updates to the ICH Good Clinical Practice guidelines call for implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting that are intended to increase clinical trial quality and efficiency while continuing to ensure human subject protection and data integrity. Now, biotech and specialty pharma innovators face even...
Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges in conducting early-phase, dose-finding studies. Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies include: Using dose-finding trial designs...
Quality Agreements are an effective bridge to a successful future for companies in the drug development sector – putting one in place at the start of the business relationship can prevent problems later. Quality Agreements mitigate risk and increase collaboration between partners. These agreements define timelines and establish responsibility and accountability. They supplement contractual commitments....
There is a significant unmet need for medications for addictions, chronic, relapsing disorders that lead to biological and behavioral changes that can have harmful medical and psychological consequences. Addictions are common, debilitating and costly disorders resulting in more than $740 billion a year in increased healthcare costs, crime, and lost productivity. Multiple medications have been...
The use of Clinical Endpoint Committees for centralized adjudication of efficacy and/or safety endpoints can help to standardize outcomes and optimize the quality of clinical trial data, driving study success. Some compounds and many devices face the challenge of defining efficacy or safety endpoints so that they are scientifically measurable, objective, and valid. Often, clinical...
A trial’s success depends largely on the ability to recruit and retain an adequate number of participants. Recruitment can be especially difficult in opioid clinical trials, due to a variety of factors. Here are seven things you should know about the challenges associated with recruiting patients for opioid trials: 1. Certain necessary aspects of trial...
Opioid analgesics are essential to the management of pain in many patients, but they are also associated with potential risks for abuse, overdose, and diversion, concerns which must be considered in the planning and execution of clinical trials studying these controlled substances. In this paper, we discuss the challenges of conducting clinical trials of controlled...