It comes as no surprise that putting patients first is imperative for achieving success in rare disease development programs. However, to what extent can sponsors integrate patient input into their study design while still securing the high-quality data they need? Although a bit of a balancing act, it is possible to design a study that…
Premier Research
Oncology & Hematology
The Rise of Radiotherapeutics: Brief History and Best Practices for Clinical Trials
Radiation therapy was first used to treat cancer more than a century ago, and nearly half of all cancer patients still receive it at some point during their treatment.1 Historically, most radiation therapy was given by delivering ionizing beams of radiation from outside the body, but with advances in the field of nuclear medicine, radionuclides…
Oncology & Hematology
Premier Perspective on Biomarkers in Oncology
In this era of precision medicine, biomarkers play a critical role in the rational development of novel therapies. With advances in both our understanding of cancer pathophysiology and tumor profiling technology, biomarkers can now be used to provide important insights at every stage of drug discovery and development. In this article, we explore the common…
Oncology & Hematology
Antibody-Drug Conjugates in Oncology: Key Considerations and Future Trends
Antibody-drug conjugates (ADCs) are an active area of oncology research, partly due to advances in synthetic biochemistry that may help improve the tissue specificity and cytotoxicity of these complex therapeutics. In recent years, the pace of development for this class of cancer therapeutics has been increasing, with 12 ADCs approved by the FDA since June…
Real-World & Late Phase
Leveraging Real-World Data & Real-World Evidence to Support Regulatory Decision Making
The FDA is committed to increasing sponsor opportunities to apply RWD and RWE to support regulatory decision-making.1 The goal is to use quantities of available data, streamline the drug development process, and learn how interventions perform in real-world use, outside the strictly controlled limits of a clinical trial. According to legal and scientific standards, the…
Real-World & Late Phase
A Fit-for-Purpose Path Forward: Linking RWD to Your Overall Data Strategy
Real-world data (RWD) and real-world evidence (RWE) have become an increasingly important part of the medical product development landscape. These tools can enable sponsors to optimize clinical trial designs and demonstrate the real-world effectiveness of new medical products. Part 2 of this three-part blog series outlines a fit-for-purpose approach to RWE. (See Part 1: What is…
Women's Health
Teaming Up with Sites During Trial Design
According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and potentially avoidable—protocol amendments that lengthen timelines and increase costs. Tufts CSDD also notes that more than half of the substantial amendments are implemented during the study enrollment period, mainly due to difficulties in recruiting…
Real-World & Late Phase
What is Real-World Data and Evidence and How It Can Facilitate Clinical Development
The 21st Century Cures Act (Cures Act)1 signed into United States law in 2016 aims to accelerate medical product development and bring innovations to patients faster through real-world evidence (RWE) to support regulatory decision making. Incorporating real-world data (RWD) and real-world evidence (RWE) can help pharma and biotech companies optimize clinical trial designs and demonstrate…
Managing clinical trials requires extensive planning of patient enrollment. Clinical trials may be more cost-effective with better forecasts of recruitment. A variety of circumstances influence the enrollment of subjects. Several factors to consider, including the rarity of the condition being examined, the capacity of the trial sites to recruit participants, and the degree of study…
Oncology & Hematology
7 Factors Fueling the Growth of Oncology Trials in Asia-Pacific
Oncology clinical trial activity in the Asia-Pacific (APAC) region has been robust over the past decade, increasing 138 percent from 2010 to 2020.1 In the past, most studies conducted in APAC countries were later studies, but there has recently been an uptick in the number of phase 1 trials. This bustling activity, in combination with…