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

• Strategic Considerations For Regulatory, Operational, And Commercial Success In Dementia Research

  Given the burden that caring for individuals with dementia places on both the health care system and caregivers, research and development efforts now extend beyond Alzheimer’s disease to explore a mosaic of syndromes, each of which presents unique and significant challenges, in part because so much remains unknown about the pathophysiology, clinical presentation, and course of these conditions.

• Increasing Patient Participation In Clinical Trials: Six Areas Of Focus From Patients And Advocates

  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.

• Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation

  Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

• When Clinical Trials Meet The Real World: Bridging The Experimental And Post-launch Divide With Data Integration

  Real world evidence and pooled clinical trial data are becoming increasingly available, linkable and minable to find valuable insights quickly. As we evolve into a new era of data integration, biopharma companies stand to benefit enormously from bridging the experimental and post launch worlds of clinical data to support the entire product lifecycle. 

• A Guide To Evaluating eRegulatory Software For Clinical Research Sites

  Researching eRegulatory management software for your investigative site? Start with this easy-to-follow buyer's handbook on the most important features to consider.

• Informed Consent: 6 Approaches To Increase Clinical Trials Participant Comprehension

  Ensuring participants have appropriate knowledge of a study is a crucial goal of the informed consent process. This paper describes six research-based approaches for improving informed consent and supporting participants’ understanding of the studies they are asked to join.