Patient and Stakeholder Engagement

Clinical Research: Phase 1 - Phase 4

Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research

Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of...

Global Compliance

Data Protection Part 3: Key Considerations for Clinical Trial Recruitment

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...

Clinical Research: Phase 1 - Phase 4

The Role of Long-Acting Injectable Antipsychotics in Schizophrenia

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...

Patient and Stakeholder Engagement

Premier Voices #8: Engaging Patients in Clinical Trials w/ Alan Thomas

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...

Medical and Regulatory Affairs

5 Reasons to Consider APAC for Clinical Trials

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...

Clinical Research: Phase 1 - Phase 4

Premier Insight 267: From KOLs to Patient Advocates, Using Every Tool to Fight a Rare Disease

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...

Patient and Stakeholder Engagement

Premier Voices #7: Rare Disease Advocacy & International Ataxia Day w/ Alan Thomas (Ataxia & Me)

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...

Clinical Research: Phase 1 - Phase 4

Operational Challenges of Neuroscience Clinical Trials, Part 3: Patient Recruitment

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...

Patient and Stakeholder Engagement

The Art and Science of Selecting Patients for Phase 1 Oncology Studies

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...

Clinical Research: Phase 1 - Phase 4

Premier Voices #2: Registry Studies & Natural Histories in Rare Disease Trials w/ Angi Robinson & Juliet Moritz

 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...