GUEST COLUMNISTS

CLINICAL TRIAL WHITE PAPERS

  • Comparator Local Sourcing For Clinical Trials

    This growing demand for comparators is causing many supply chain managers to explore available sourcing options. This paper examines the fundamentals of local sourcing, including the benefits and challenges of sourcing locally, and the circumstances under which local sourcing can be a sound decision. Recommendations are provided for avoiding common pitfalls in implementing a local sourcing strategy.

  • Tips For Submitting Expedited Review Studies

    Becoming familiar with the expedited requirements is a good way to ensure you can navigate the review process effectively. Set yourself up for success by reading 6 tips for submitting research studies for expedited review.

  • EU GDP Guidelines: Implications For Shipping Clinical Materials Into The European Market

    It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.

  • Addressing Cultural Fit With Outsourced Resources: How Can You Find The Right Match?

    In order to make any outsourcing model work effectively, it is essential to evaluate and match both the skill set and the cultural fit of the candidate and sponsor. This article will discuss strategies for finding the best cultural match and the impact it can have on implementing a successful FSP model.

  • How Sponsors Can Ovecome The Growing Challenges In Clinical Trial Budgeting And Negotiation

    This paper seeks to explore the most crucial obstacles to successful budget design and negotiation in light of the current complexity experienced across the clinical trial universe. It highlights how technology can streamline these traditionally manual, time-consuming workflows, increase transparency and predictability, and deliver more current, and accurate data for an optimized study start-up.

  • The Tale of Two Trials

    The debate surrounding best practices for patient management and data collection during clinical trials is ongoing. In this paper we take an in-depth look at the benefits and drawbacks of the traditional, paper-based outcomes assessment method, as well as the advantages of the emerging electronic clinical outcomes assessment (eCOA) solutions.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Actigraphy For Fibromyalgia

    Fibromyalgia (FM) is a neuropathic pain that affects millions of people in the United States. It, like most pain conditions, affects daily activity and sleep. The pain sensations are best measured by recording the patient’s own perceptions (patient-reported outcome) but the related effects of pain on activity and sleep can be measured objectively with actigraphy. Read how actigraphy provides useful insights into the activity patterns in patients with fibromyalgia.

  • Protected Ambient Sample Shipping

    A leading pharmaceutical research company needed help supporting a two-year clinical study of progressive multiple sclerosis. In order to accommodate multiple sampling time-points, the shipping kit needed to hold up to 17 test tubes in isolation, instead of the standard six or seven, and needed to maintain the test tubes within a very limited target temperature range despite exposure to extreme heat or cold for extended periods of time.

  • Tumor-Agnostic Treatments: A Game Changer For Rare Oncology Trials

    As our understanding of the molecular characteristics of tumors has improved, there has been a tremendous leap forward — not only in targeted therapies but also in the development of tumor-or tissue-agnostic treatments. Now, with precision or personalized medicine, treatments can be targeted to a subgroup of patients rather than relying on a one-drug-fits-all model. In this blog post, we explore the changing rare oncology landscape and novel approaches to rare cancer trials.

  • It’s About How The Social System Works, Not Just The Science

    After a failed attempt from their first CRO, this manufacturer turned to Premier Research to successfully recruit and retain 24 patients for a Phase I proof-of-concept study of inflammatory bowel disease.

  • Can CROs Rise To The Patient Access & Recruitment Challenge?

    It is not surprising that the task of CRO selection is often stress-inducing. One element we explore in depth is the influence of preferred provider agreements or the lack thereof. We ask clinical development outsourcers about the attributes they focus on under three selection environments.

  • Prioritizing Patient Safety While Pursuing High-Quality Data

    While COVID-19 has frozen much of the world, healthcare marches on. The studies that will determine the safety and efficacy of health-improving and life-saving drugs must continue. But now, attending scheduled site visits and collecting critical information from patients have become safety issues for patients and trial staff alike. Read more about how sponsor clients and the patients can mitigate risks for clinical trials amid COVID-19.

CLINICAL LEADER CONTENT COLLECTIONS

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When the pandemic hit, many hospitals, clinics, and sponsor companies were caught by surprise. The effort to protect patients and keep them away from clinics put many trials in jeopardy. Amidst the chaos, sponsors and regulators were able to scramble and keep many trials going while considering the safety and needs of participants. In this collection of articles from Clinical Leader, learn how companies not only survived, but created new policies that will be tomorrow’s best practices.

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

  • Addressing Disparities And The Democratization Of Clinical Trials

    Advancements of the protocols, tools, and technologies that were highly leveraged during the COVID-19 pandemic are the key to breaking down the barriers that perpetuate clinical trial disparities.

  • Let’s Tackle The Hidden Real-World Reasons For Poor Clinical Trial Diversity

    To achieve better outcomes and health equity for historically underserved populations, we must address the not widely acknowledged, hidden, real-world reasons for such poor diversity in clinical trials. Here, we will pull back the covers on the issues we must tackle to improve diversity in trials. 

  • 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.