GUEST COLUMNISTS

CLINICAL TRIAL WHITE PAPERS

  • Virtual Approaches In Oncology Clinical Trials During COVID-19 And Onward

    Patients living with cancer are among the most vulnerable during the pandemic, but sponsors and researchers understand oncology drug development must continue. This paper will discuss how COVID-19 is driving change in the oncology trial landscape and how these insights may shape the future of post-pandemic clinical development. Given the unique concerns of cancer patients, the scope of the discussion will focus on outlining innovative and flexible tech-enabled approaches and operational adjustments that can improve the patient experience.

  • Commercialization Accelerator For Emerging Companies

    For any life sciences company bringing its first product to market, the “commercialization to-do list” is long and punctuated by one critical strategic decision after another. This guide explores lessons learned from industry leaders facing the challenges of building commercial operations capabilities and how they avoid pitfalls.

  • 10 Tips For Writing Compliant Clinical Trial Participant Materials

    Recruitment materials are a potential participant’s first introduction to the study, and post-consent materials can influence an individual’s decision about continued participation. It is important to adhere to the principles of participant protection, allowing participants to make informed decisions about what is in their own best interest, with the materials that appear at the earliest stages of recruitment as well as through the life of the study. Well-informed prospective and current participants lead to improved recruitment and retention rates.

  • Vital Tools For Centralized Statistical Monitoring Of eCOA/ePRO Data

    As the industry moves to adopt patient-centric approaches to clinical trials, there is an opportunity to adopt the best practices of QbD and risk-based methodologies to ensure that patient reported data are effectively being monitored. In this paper, we discuss the value of using advanced technology — specifically Centralized Statistical Monitoring technology - to oversee subject safety and data quality/integrity in a risk-based manner.

  • Removing Barriers: Reimbursement And Compensation For Participation In Oncology Clinical Trials

    Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Insmed’s Fast And Successful EDC Study Builds With Veeva Vault CDMS

    Insmed describes the critical success factors enabling them to incorporate significant protocol changes and still hit their FPI deadline with Vault EDC.

  • Comparative Analysis For Non-IND Sites

    A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
    coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward.

     

  • Warming Up To Hybrid Trials

    In a November 2020 survey, Industry Standard Research (ISR) asked 121 clinical trials outsourcers at sponsor companies a series of questions about their company’s use of hybrid trials. This article offers insight on prevalence of use, respondents’ overall impressions, and the concerns and downsides of hybrid trials.

  • How To Cut The Negative Impact Of Protocol Amendments

    When planning a clinical trial it’s common for sponsors to overlook or underestimate the possibility of protocol amendments. The COVID-19 outbreak has shown the inflexibilities of much of the clinical trials industry. Read how having a CRO that can remain focused on being agile and flexible can minimize the impact of protocol amendments on your trial.

  • Key To A Faster, More Flexible Clinical Trial Process

    How a single, integrated data analytics and visualization platform, supported by an experienced partner, can help you move your investigational product to market more quickly.

  • Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial

    A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.

CLINICAL LEADER CONTENT COLLECTIONS

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The effort to protect trial participants during a global pandemic led many companies to adopt technologies they had not used in the past. One of those is virtual or decentralized trials. In this collection of articles from Clinical Leader, learn how sponsor companies are adapting to the new normal in clinical trials and reducing risk while creating tomorrow’s new study paradigms.

More Content Collections

FOCUS ON PATIENTS

  • Best Practices For Implementing Decentralized Clinical Trials

    While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.

  • Lessons For Leaders: The Loud And Lasting Impact Of COVID-19 On The Future Of Clinical Research

    Last year, shortly before the pandemic, we predicted that clinical trials of the future would be more open, more human-centered, and more integrated in the healthcare ecosystem, providing guideposts for how industry will adapt along these three themes. COVID-19 has both accelerated these trends and highlighted new challenges for R&D leaders to address.

  • 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.

EMBRACING DIVERSITY & INCLUSION