With the advent of the EU’s General Data Protection Regulation, individuals now have expanded rights to information regarding the use of their personal data. These changes impact several aspects of the clinical trial recruitment process and may require sponsors and CROs to update their data collection and protection protocols and processes for informed consent. Consent...
Use of long-acting injectable antipsychotics is often reserved for patients with chronic or treatment-refractory schizophrenia or repeated non-compliance issues. However, recent studies have consistently found a role for these treatments both soon after diagnosis and in the treatment of chronic disease. A severe and often debilitating neurodevelopmental disorder, schizophrenia affects a person’s ability to think...
Clinical research certainly has evolved over the past three decades. There are more trials crossing a broader spectrum of indications, and advances in study design and execution have dramatically changed the way drugs and medical devices are evaluated and sold. But perhaps no change has been more significant than the growth in engagement on the...
Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. In fact, the number of clinical trials in...
Finding patients for trials in very rare conditions is difficult under any circumstances, and in this case the odds were really stacked high against success. The indication: a basal cell carcinoma known as Gorlin syndrome, a disease that manifests itself in large numbers of benign tumors that grow on various parts of the body. The...
This episode, we’re proud to share the first part of our conversation with Alan Thomas, patient advocate and founder of Ataxia & Me, ahead of International Ataxia Awareness Day on September 25. Alan talks about his personal journey with ataxia and how he first got started with patient awareness. Follow Alan and Ataxia & Me...
Last week, we discussed the high placebo response that plagues neuroscience clinical trials. Today we turn to another common challenge: patient recruitment. We’ll take a look at three strategies that can be used to improve trial participation: the use of several patient sources when recruiting a focus on patient-centric solutions the use of patient recruitment...
The primary purpose of early-stage clinical trials is to determine the recommended dose and toxicity profile of an investigational drug or multi-drug combination therapy. Since molecularly targeted agents (MTAs) and immunotherapies have toxicities that are distinct from cytotoxic chemotherapies, traditional dose escalation methods using toxicity-based endpoints may not be suitable for phase I studies of...
Patient registries and natural history studies are vital tools for orphan drug researchers, who often struggle with limited understanding of diseases and sparse data due to small patient numbers. In the second installment of the Premier Voices podcast with Angi Robinson, Vice President, Clinical Development Services, Rare Disease & Pediatrics, and Juliet Moritz, we...
To achieve operational excellence in gene therapy trials, sponsors must understand – and overcome – obstacles ranging from start-up regulations and site selection to patient recruitment and retention. Gene therapy holds promise for treating a wide range of diseases, from cancer and diabetes to rare genetic disorders. It has also sparked great interest because it...