GUEST COLUMNISTS

• The Evolution Of Biomarker-driven Approaches To Clinical Trials

  Greater understanding of the specific and varying genetic bases for cancers has provided greater opportunities for clinical trials to take advantage of patient genetic variability for recruitment and segmentation purposes. In this article, historic data provide insights into the evolution and future of biomarker use in precision medicine.

• Starting A Career In Clinical Research: 7 Things We Wish We Knew

  The clinical research industry is facing a talent shortage that could become acute in the next decade. A main contributor to this shortage is a lack of focused intervention at every level to identify the skills, behaviors, and knowledge that will enable motivated candidates to begin and mature their careers in the industry. 

• New Approaches In Patient Tracking For The Rare Disease Sector

  While we have seen exponential growth in the effort to develop drugs to treat rare diseases in the 30 years since the Orphan Drug Act was introduced, unique challenges remain. Awareness of rare diseases is often low among stakeholders including physicians, healthcare providers, payers, and even patients themselves; trial protocols and regulatory pathways may be unclear, especially for investigational rare disease drugs that are first-in-class; and data on disease incidence, onset, progression, and burden are often limited.

• Janssen’s Patient-centric Approach To Psychiatric Disease Management

  Diseases as complex as those of the brain require an equally complex approach, centered on the unique needs, goals, and circumstances of the individual patients, as well as the loved ones who support them. Listening, empathizing, understanding — these basic human interactions will have a critical role in our ability to reach our goal and deliver transformational medical innovations.

• Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions

  By forcing the FDA to become comfortable with the use of real-world data in order to authorize COVID-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of real-world evidence (RWE) it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE.

• How EMD Serono Is Bringing Diverse Patient Voices Together

  The pandemic has created an opportunity to address some of the causes underlying clinical care inequities. And while combatting these issues will take time, much can be done by first addressing the gap for minorities in clinical trials. This is a topic I am passionate about both personally and professionally as a female Hispanic chief medical officer.

• Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?

  The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.

• Ensuring Patient-Friendly Clinical Trials For Complex Disorders — A Small Biopharma’s Playbook

  Rezolute, a small company working in the rare pediatric disease space, is developing a new therapeutic option specifically for patients with congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. Connecting and partnering with advocacy groups and physicians is paramount in the company's clinical trial execution. 

CLINICAL TRIAL WHITE PAPERS

• Braving The Complexities Of Immuno-Oncology Trials

  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.

• Lessons Learned When Implementing A Risk Management Program

  The design and implementation of risk management programs can be challenging. This white paper uncovers key lessons learned from our experience with over 120 RiskMAPs and REMS programs - which spans various therapeutic areas and targeted risks.

• Pharmacy Services In A Phase I Clinical Research Unit

  This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.

• Compensating Participants In Clinical Research: Current Thinking

  New research on how people make decisions about research participation, and new approaches to the question of payments and compensation to participants, bring a new perspective; are payments to participants actually too low? This paper explores this question, and whether we should, in fact, worry much less about restricting compensation for research participants.

• Bringing Real World Evidence Into Clinical Research

  Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

• Mitigating Inherent Risks In Global Sample Processing

  The global demand for specialized sample processing has grown dramatically however despite the rising need, research teams continue to struggle to obtain high-quality laboratory support services to perform sample processing. Learn how innovative flow cytometry fast turnaround and monitored, specialized processing can help safeguard samples.