The necessity of appropriately training raters for reducing variability in measurements, rater interpretation, and bias and scale administration errors in COA implementation are outlined in this whitepaper.

In this whitepaper we introduce the basic principles of sound longitudinal qualitative research and offer advice for sponsors considering such an approach as a way of insuring that their development efforts are patient centric.

Currently, 6,000 to 8,000 rare diseases have been identified worldwide, and an estimated 250 to 280 new ones are discovered annually. ICON analysed data on the use of patient-reported outcomes measures (PROMs) in orphan drug labeling claims and performed an extensive literature review on the use of PROMs in all phases of clinical research.

In the US, payers have historically focused on efficacy and safety endpoints as well as cost, with very little attention given to patient reported outcomes (PROs). With the increase in patient centricity, we surveyed US payers to learn if they were changing their approach.

The FDA encouraged sponsors to explore alternative methods for patient safety assessments, in the recent guidance on clinical trials during COVID-19.  Decentralised and hybrid trials have been prevalent for years, but sponsors have struggled to execute effectively.  Explore the perceived barriers and how you can make these models a feasible option for the future.  

In our latest whitepaper, we follow a theoretical patient through the entire clinical trial journey – from initial contact for an early study through transition to treatment with an approved product. At each stage, we explore how IoMT can increase clinical development programme efficiency by reducing the burden on patients, caregivers, pharma companies and medical device and diagnostic manufacturers.

While pharma has historically focused their medical communications strategies and scientific data dissemination plans to physicians and payers, they have done little to explore the needs of nurses, who also play a central role in patient care. We surveyed 100+ oncology nurses to understand their medical communication needs and preferences and to identify any gaps.

Read our whitepaper for insights on how to design and execute a medical communications program that speaks directly to nurses for greater patient access and engagement across therapeutic areas.

ICON is working with the International Consortium for Health Outcomes Measurement (ICHOM) to develop The Global Outcomes Benchmarking (GLOBE) program. Rather than focusing on clinical indicators, ICHOM shifts the focus to outcomes that patients care about, including functional improvements and the capacity to live productive lives.

ICON Insights: mHealth devices allow for better treatments and clinical outcomes - Continuous monitoring of patients enables continuous treatment adjustments and alerts clinicians when emergencies arise - resulting in better, more personalised treatment and improved clinical outcomes, with fewer clinic visits and greater independence for patients.

The long journey towards patient centricity - A look at the regulatory efforts implemented in the last 30 years to include the patients’ perspective into drug development.

Today, fewer and fewer patients passively accept physicians’ advice. Patients are increasingly active, informed consumers entering clinics armed with research and opinions about their healthcare options. They desire data on similar patients while calculating the benefits and risks of their choices. To the patient–consumer, "precision medicine" represents the ideal standard of care: the individualised, evidence-based treatment that provides the best opportunity for a positive outcome. Read our three-part series exploring the patient-consumer:

Part One: From biomarkers to biosensors

Part Two: Beyond biomarker-based patient stratification

Part Three: Applications for wearables and apps in precision medicine