Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

How to Select Drugs to Switch from Rx to OTC

Before the 2012 Food and Drug Administration (FDA) Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, sponsors were transitioning prescription drugs (Rx) to over-the-counter (OTC). Streamlined access to effective treatments clearly benefits patients and payers. At the same time, easier access for consumers typically results in increased sales and profitability for pharma and biotech companies. As...

Clinical Research: Phase 1 - Phase 4

Making the Switch from Rx to OTC

Introduction With the support of patients, regulators, and payers, pharma and biotech companies’ interest in converting prescription drugs (Rx) to over-the-counter (OTC) is growing. In 2021, the sales value of Rx-to-OTC switches was around $35 billion USD. According to Future Market Insights, it is expected to rise at 5.3 percent compound annual growth rate (CAGR),...

Clinical Research: Phase 1 - Phase 4

Patient Enrollment and Retention: Overcoming Challenges in Observational Research

The challenge of enrollment for observational research Patient enrollment and retention for investigational trials are notoriously difficult. How is enrollment affected when there is no direct benefit to the patient: no breakthrough study drug with the potential to cure, no added caregiver time, no meaningful compensation for participating? Observational studies, by design, demand a continuation...

Clinical Research: Phase 1 - Phase 4

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...

Clinical Research: Phase 1 - Phase 4

Conducting Successful Oncology Trials in the Asia-Pacific Region

The Asia-Pacific (APAC) region now ranks first in the world for total number of active oncology clinical trials, with China alone accounting for more than half of those studies.1 To take advantage of the potential benefits of conducting clinical research in APAC countries, sponsors need to understand the nuances of designing and operationalizing studies in...

Clinical Research: Phase 1 - Phase 4

Designing and Conducting Decentralized Dermatology Trials

August 25th, 20222:00 p.m. AET / 1:00 p.m. KST / 12:00 p.m. SGT Conducting rigorous assessments and obtaining the highest-quality data are essential to dermatology clinical research. Traditional clinical trial designs can pose obstacles for patients with busy work and personal lives, especially if they live far from a study site. Decentralized trials open opportunities...

Clinical Research: Phase 1 - Phase 4

Making the Asia-Pacific Region a Destination of Choice for Oncology Clinical Trials

Introduction Over the past decade, the Asia-Pacific (APAC) region has seen the most robust growth in oncology clinical trial activity, with a 138 percent increase over the period from 2010 to 2020. In fact, APAC now ranks first in the world for total number of ongoing oncology clinical trials, with China accounting for more than...

Clinical Research: Phase 1 - Phase 4

Expert Guide to Decentralized Dermatology Trials: Five Strategies for Study Success

To optimize the likelihood of success, dermatology clinical trials should be designed with the patient in mind, minimizing the burden of participation and maximizing accessibility for a diverse population of qualified patients. In a development space as active as dermatology, where competition for eligible participants is intense, adopting a patient-focused approach is essential for meeting...

Clinical Research: Phase 1 - Phase 4

Addressing the Top 7 Challenges in Decentralized Dermatology Trials

Each year, nearly 85 million Americans see a physician for at least one skin disease, with $75 billion in direct costs to the U.S. healthcare system.[i] While the FDA has approved more than 110 dermatology drugs, these treatments address only about 30 indications, leaving the vast majority of known skin conditions unaddressed. In recent years,...

Clinical Research: Phase 1 - Phase 4

Addressing Challenges in Bringing Male Contraceptives to Market

There are currently more than a dozen categories of female birth control with proven efficacy on the market. Conversely, the only options available for men today are condoms and vasectomy, despite decades of research. No new male contraceptive products have entered the market since the condom was created in the 1800s. This is in part...