GUEST COLUMNISTS

• Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19

  Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.

• Inside Novo Nordisk’s Patient Advisory Board Meetings

  Novo Nordisk's first DEEP (Disease Experience Expert People) Advisory Board meeting brought together leaders of patient organizations, patient advocates, and patients from five countries to participate in a dialogue with the company's Global Patient Relations team, project vice presidents, medical specialists, and trial managers.

• What Patients Are Telling Sites About Trial Participation During COVID-19

  LMC Manna conducted interviews with patients who are currently enrolled in a Phase 3 clinical trial at one of their sites, with questions focusing on the impact of COVID-19 during their trial participation. Here's what they had to say.

• Post-COVID-19 Clinical Trials: Finally Understanding The Meaning Of Patient-Centricity

  Despite being instrumental to our mission of making lifesaving therapies accessible to all, patient perspectives are far too often lost in the wake of “flashier” news about COVID-19 therapy approvals, supply chains, and scientific breakthroughs.

• An Update On Regulatory Guidance For U.S. Clinical Trials During COVID-19

  To preserve integrity in clinical trials and mitigate the need to place clinical trials on hold indefinitely, the FDA has issued updated guidance to support important research and exploration of new treatments. Additionally, the U.S. Department of Health and Human Services’ Office of Human Research Protection issued guidance to assist researchers in applying human subject protection regulations.

• Diverse Enrollment In Clinical Trials: What Do Successful Research Sites Have In Common?

  Diverse enrollment in clinical research studies is a complex issue that has multifaceted implications for clinical research sites. An understanding of the research site community’s perceived awareness and current ability to enroll these populations is lacking in the clinical trials landscape.

• Moving Virtual Trials From Aspiration To Reality In Today’s Environment

  With the COVID-19 pandemic upon us, we are at a place where the business case is clear, the barriers to adoption are largely removed, and sites and participants alike have begun accepting virtual trials as not just an option but a must.

• COVID-19 & Clinical Trials: Understanding The Long-Term Impact

  While most regulatory agencies have stated an intention to be flexible during these unprecedented times, it is critical that drug developers continue to monitor their risk diligently and develop contingency plans to adapt and respond to factors that affect their clinical development programs.

CLINICAL TRIAL WHITE PAPERS

• Maximizing Success In Early Stage Oncology Trials: Considerations And Strategies In The Era Of Molecularly Targeted Agents

  Making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. This white paper discusses considerations and strategies for maximizing the likelihood of success in early phase oncology trials and developing significantly improved therapeutics for patients.

• 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.

• Successful BYOD In Any Phase

  The idea of BYOD for use in clinical trials during any phase has historically been conceptualized as a futuristic alternative, rather than what it actually is — a viable option for many clinical trials. While there has typically been hesitance among sponsors and CROs to choose a BYOD model for their study, there is an increasing number of trials that have successfully deployed this model with great results. Read more about the Advantages and Misconceptions of BYOD and what you should consider if you are deciding whether BYOD is an option for your study.

• Botanical Medicines In Research

  Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.

• Unpicking The Complexity Of Importer Of Record Processes In Globalized Clinical Supply Chains

  Embracing Importer of Record best practice is key to reducing risk and promoting timely and compliant supply to patients enrolled in global clinical trials. Download Almac’s whitepaper, for information on how to embrace safe, efficient and cost-effective global supply chain operations, through the COVID-19 pandemic and beyond.

• Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct

  As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.