GUEST COLUMNISTS

• 4 Best Practices That Kept A Biotech’s Clinical Trial Moving In The COVID-19 Era

  The timely enrollment and progression of clinical trials is critical for a pre-commercial biotech company, as delays can keep treatments from getting to patients and cost an organization significant money and reputation. When you throw in a worldwide pandemic, it’s a whole new ball game.

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

  You have a human condition to improve and a protocol to follow. All smooth sailing from here, right? Indeed, even the most well-planned clinical trial is dead in the water if the needed patients are not accessible or willing to participate.

• How Can We Begin To Solve Unconscious Systemic Bias In Clinical Trials?

  Halting disparities in clinical trials during the time of COVID-19 will take eradicating unconscious bias, building trust in diverse communities, dispelling long-held myths, constructing relationships, and educating patients, family members, and physicians.

• 5 Bad Habits The Clinical Trial Community Needs To Break ASAP

  The issue of clinical trial costs, both in terms of money and time, is big, complicated, and not at all new. In this article, I will not attempt to address or solve all of the problems that contribute to these high costs, but I will highlight some continuing root causes that I believe persist needlessly.

• 3 Essential Considerations For Running Global Clinical Trials

  In recent years, global clinical trials have become standard, and for a good reason. Expanding clinical trials across the world gives the investigational drug better opportunity to demonstrate its true impact. In this article, Dr. Roger Tell looks at three key considerations when designing a global clinical trial: selecting the most appropriate trial sites with a representative patient population, choosing to work with the right partners, and ensuring you are up to speed with local regulatory and clinical requirements.

• Unpacking FDA’s New Guidance On Collecting Patient Experience Data

  The FDA recently released one of what is to be four new guidances providing a general overview of patient-focused drug development. This article summarizes each component of "Guidance 1: Collecting Comprehensive and Representative Input" and details how the guidance may impact sponsors of clinical trials.

• Transformative Reflections On The Life Science World, Post-COVID-19

  The post-pandemic response has led to drastic public health changes and new ways of creating diagnostics and treatments. COVID-19 was a turning point. The pandemic exposed weaknesses in internal processes, reliance upon traditional methodologies, and leadership gaps. It demonstrated a valuable capacity to leverage innovative technologies for prioritizing patient safety, to rapidly implement creative ways of enabling healthcare providers to continue providing care, and a new framework for solving complex medical challenges.

• Searching For Clinical Trials: How Can We Improve The Patient Experience?

  While adherence to ClinicalTrials.gov guidance is not optimal, the bigger issue is the widespread absence of patient focus in most brief titles and brief summaries.

CLINICAL TRIAL WHITE PAPERS

• Clinical Trials & Travel Tribulations: Improving Access And Outcomes For Patients And Caregivers, Sites And Sponsors

  In this paper, we dive into the logistical and financial challenges which increasingly impact all clinical trial stakeholders - from patients and sites, to sponsors and contract research organizations (CROs). Yet with proper planning and the right partners on board, travel arrangements and reimbursement programs can make the trial and patient experience more comfortable and successful for everyone.

• 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.

• Three Considerations For Successful Global Sample Processing With A Central Laboratory

  Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywide challenge, particularly within the context of global trials. This paper reviews three of the keys to success for global sample processing.

• 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.

• ICH GCP E6 (R2): A Primer For Small Biotech And Specialty Pharma Companies

  With recent updates to the ICH Good Clinical Practice guidelines biotech and specialty pharma innovators face even greater sponsor responsibilities, the most significant of which may be design and development of Clinical Quality Management Systems to achieve compliance with the revised guidelines. In this white paper, we will explore the revised guideline and discuss its impact on small biotech and specialty pharma sponsors, with a focus on risk-based approaches to quality management.

• Innovative Strategies To Maintain Product Integrity In Biologic & Biosimilar Clinical Studies

  Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies which will almost certainly require cold chain handling.