White Papers

1. Increasing Patient Participation In Clinical Trials: Six Areas Of Focus From Patients And Advocates 2/14/2020

   Meaningful collaboration between patients, sites, and sponsors can yield improved clinical trial outcomes. As part of that important collaboration, we see that effective patient input has the potential to increase patient participation rates in clinical trials. Incorporating patient insights into clinical trial design and execution is the first step.

2. The Most Important Voice Is Missing: The Case For Including Patient Insights In Protocol Design 2/14/2020

   Patient voice isn’t an accessory; it’s foundational. Patients are key to clinical trials, and relegating them to mere “subjects” diminishes their value. Including the patient voice in study design and development can make an enormous difference in recruitment, enrollment, and retention. Doing so also pleases regulators, who are increasingly putting a premium on patient-focused drug development. It doesn’t have to be difficult, but getting it wrong--or not doing it at all--can undermine a trial.

3. A Vast Unmet Need: Challenges In Alzheimer’s Disease Clinical Trials 2/12/2020

   Despite intensive research, nearly 15 years have passed since the last new Alzheimer’s disease medication was approved. Understanding the obstacles inherent in Alzheimer’s clinical trials, from high screen failure rates to lengthy trial durations that are demanding for both patients and caregivers, can help sponsors plan for – and overcome – these challenges. This paper reviews the current global pipeline of Alzheimer’s trials and their geographic locations, describes innovations in trial design, and discusses considerations of optimal clinical trial processes, including preclinical patient populations, clinical assessments sensitive to the earliest disease-related changes, and biomarkers as outcomes of clinical trials.

4. Challenges In Medication Development For Addictions 2/12/2020

   There is a significant unmet need for medications for addictions, chronic, relapsing disorders that lead to biological and behavioral changes that can have harmful medical and psychological consequences. This paper presents an overview of the medications that have been developed for addictive disorders, the study endpoints that have been used for market approval, and the challenges companies may face when developing medications for addictive disorders.

5. CNS Trials: Challenges and Opportunities for Neuropsychological Testing 2/10/2020

   Central nervous system (CNS) disorders represent a major medical challenge and a significant opportunity for therapeutic innovation. Sponsors who have a clear understanding of the regulatory landscape and neuropsychological testing modalities available are poised to address critical unmet needs for the millions of people living with CNS conditions.

6. From Psoriasis To Behçet’s: The Evolution Of Biologics In Dermatology 2/10/2020

   There is a clear shift in dermatology drug development towards biologics, targeted treatments, and rare skin diseases and away from topicals and symptomatic treatments. Learn more about the number of indications that are in development.

7. Mapping The New Landscape Of Orphan Drug Development 2/4/2020

   The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

8. Braving The Complexities Of Immuno-Oncology Trials 2/3/2020

   Immuno-oncology trials are increasing in prevalence and, for many reasons, are much more complex than standard clinical trials. Learn how partnering with an experienced central lab can alleviate these challenges, create efficiencies and save researchers time and expense.

9. Three Considerations For Successful Global Sample Processing With A Central Laboratory 2/3/2020

   Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywide challenge, particularly within the context of global trials. This paper reviews three of the keys to success for global sample processing.

10. Fusing Specifications And Design For Data Collection Casebooks With Veeva Vault EDC 1/31/2020

    Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.