The TRIbune
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The TRIbune Newsletter

The TRIbune is TRI’s newsletter. It is designed to enhance pharmaceutical, biotechnology, clinical research, and communication professionals’ industry knowledge. It is written by TRI’s subject matter experts to provide new perspectives, insights, and tips on the latest challenges, opportunities, and news in the industry. The TRIbune covers a wide-spectrum of topics including: regulatory updates, innovations, therapeutic areas, healthcare advancements, and new technologies. Stay up to date on current challenges and solutions within industry that affect you.


2020


TRI Participates in Rapid Response to SARS-CoV-2 Infection (COVID-19)

May 2020

The first quarter of 2020 saw the harsh reality of a global health emergency set in, as the novel coronavirus spread across the world, the respiratory illness now known as COVID-19. As the regional disease became a global pandemic, TRI has supported the search for effective treatments and vaccines, and successfully met the challenges in supporting our study sponsors.


Inclusion of Immunosuppressed Patients in Oncology Clinical Research:
Promises and Challenges of Immune-Based Therapeutic Strategies

May 2020

Each cancer patient is unique, and significant safety concerns have precluded clinical testing of many cancer treatments in patients with other preexisting conditions. Patients with underlying immunological complications, such as those with autoimmune diseases or those who received a solid organ transplant (SOT), constitute one such group that has been historically excluded from cancer clinical research.


The Importance of Categorizing and Analyzing Screen Failures when Recruiting Clinical Trial Participants

May 2020

The ability to recruit eligible participants is one of multiple components that contribute to the success of a clinical trial, impacting study timeline, resources, and cost, as well as the participant/patient experience. Screen failures are potential study participants who do not fit the parameters or eligibility criteria set by the protocol. The study design should include a mechanism for compiling the screening data from participating sites, categorizing failure reasons based on the eligibility criteria, and analyzing the reasons recruitment may not be on target.


Sustainable Event Planning

May 2020

As the state of our environment becomes an increasingly prevalent issue facing society, a sustainable approach to event management emerges as a priority for businesses. According to the United Nations World Commission on Environment and Development, “sustainable development is development that meets the needs of the present, without compromising the ability of future generations to meet their own needs.” TRI implements this concept into our everyday operations and especially into our process conducting events such as medical meetings, symposiums, and large conferences.


 2019


Using Stochastic Analytics in Subject Recruitment in Clinical Trials

November 2019

One of the biggest challenges in planning and conducting clinical trials is the modeling and predicting of subject accrual. About 20% of all trials are terminated or closed due to inability to recruit subjects. Additionally, about 80% of completed trials fail to meet recruitment goals. Predicting subject accrual for clinical trials has long been a topic of significant interest. It affects resource allocation and budgeting not only during the planning of a clinical trial, but also during the operation of an ongoing trial.


Harmonization and Contradictions Among Human Clinical Research Guidelines Regarding Consent of Participants

November 2019

The understanding of what “informed consent” for clinical trials means to all parties involved has been under increased scrutiny. There are several internationally agreed upon documents that provide guidance; however, many disparities in the understanding and interpretation of concepts within these documents remain.


Has the Revised Common Rule Improved the Readability of Consent Forms?

November 2019

Adequately informing scientific research participants about the nature of a clinical trial is an important part of ensuring their protection. However, researchers have recently criticized the poor readability of consent forms, stating that they can be overly long and confusing. In the United States, one of the regulations governing informed consent is the Common Rule, Title 45 CFR part 46. The Revised Common Rule, which went into full effect on January 21, 2019, includes updates specifically designed to improve the readability of research consent forms, but it also contains several revisions that may decrease readability. How has the Revised Common Rule impacted readability overall?


EHRs and EDCs — Future Integration Benefits and Challenges

April 2019

The use of Electronic Health Records (EHRs) has transformed documentation and delivery of healthcare in the United States (U.S.). An essential contribution to the increasingly digital healthcare infrastructure since their emergence, EHRs have become unanimously integrated into clinical practice, mostly to capture crucial billing data and optimize clinical care. From 2008 to 2016 adoption of EHRs by office-based physicians more than doubled from 42 to 87 percent.


Vulnerable Populations in Oncology Research:Challenges and Opportunities for Participation of Persons with HIV/AIDS in Cancer Therapy Clinical Trials

April 2019

Although progress has been made in the global fight against HIV/AIDS, the epidemic continues in the United States (U.S.) and international community. Nearly 37 million people worldwide are living with HIV, and 9.4 million of those infected are not aware of their HIV status. Globally, AIDS-related deaths dropped by 45 percent since their peak in 2004. Yet the rate of HIV transmission remains unacceptably high, with 1.8 million new infections occurring worldwide in 2017 alone equating to about 5,000 new infections per day.


 2018


How to Market Medical Devices in the U.S.

February 2018

Which regulatory pathway is the best fit for a specific medical device platform? How to get regulatory clearance for a device? Is clinical data needed to support applications? All medical device innovation companies, particularly newer start-ups, are plagued by these questions once they have a promising technology that could benefit the human population. With each new scientific advancement, there is a requirement for higher understanding of the regulatory implications before a medical product can be developed and marketed in the United States.


Special Populations Underrepresented in Oncology Research: Challenges and Solutions to Engage the Hispanic Population

February 2018

There are 55 million Hispanic persons living in the United States, making them the largest minority group in the country. Hispanics currently make up 17% of the US population, representing a 43% increase over the past ten years. This percentage is expected to grow to an estimated 30% of the population by 2050. Despite the evidence that the Hispanic population is increasing at a formidable rate, they not only face disadvantages in health care access but are significantly underrepresented as participants in biomedical research.


TRI Gives Back to the Community by Supporting over 50 Charities

February 2018

For more than 27 years TRI has been donating and supporting a growing list of charities each year through the Anthony Lee Memorial Fund created in honor of TRI’s founder. The company is now contributing to over 50 different charities annually. TRI donates to international and national charities with a focus on supporting organizations that have a direct impact on our community.


 2017


ICH E6 Amendment Emphasizes Risk Based Approaches in Clinical Trials

July 2017

In November 2016, ICH E6 was amended to reflect current industry needs and practices. The risk management processes included in the recent addendum focus on oversight activities and quality management of the clinical trial. There is no “out of the box” solution to implementing a risk based monitoring program and quality management system. In developing these programs, the sponsor should include applicable stakeholders, take into consideration associated risks for each phase of a clinical trial, and coordinate the responsibilities of managing identified risks.


Understanding the Final Revisions to the Common Rule and the Implications for Informed Consent

July 2017

Originally promulgated in 1991, the Federal Policy for the Protection of Human Subjects (the Common Rule) codified the ethical framework for the conduct of research involving human participants that is conducted or supported by the federal government. Throughout the years technology and clinical research landscapes have modernized, making it essential for the Common Rule to reflect these advances. In the TRIbune Winter 2017 edition, we discussed proposed updates to the Common Rule as outlined in the Notice of Proposed Rulemaking (NPRM)”.


Selecting Study-Appropriate Clinical Sites in 3 Steps

July 2017

In the industry we often hear staggering statistics about the number of trials that are delayed or fail to meet their goals. For example, you may have heard 45% of clinical trials are completed late, 70% of trials experience study start-up delays, and approximately 80% of trials fail to meet their initial target enrollment on time. Part of a major risk mitigation strategy to avoid some of these challenges is selecting clinical sites that fit the unique needs of the study – because when it comes to clinical research one size does not fit all.


What is New in the Chemical Safety Law?

January 2017

Many of us working in the clinical trial and global public health arenas are familiar with the stringent United States (U.S.) and international drug safety laws and regulations ensure patient safety. But we might not often think about chemicals people are exposed to everyday that are not covered under those laws and regulations because they are not drugs, cosmetics, or food. In the past, these industrial chemicals, found in everything from fragrances to tires, have been regulated much less rigorously.


Going Global? Points to Consider When Planning International Trials

January 2017

Trials conducted in non-U.S. countries, sometimes known in the Contract Research Organization (CRO) industry as Rest-of-World (ROW), must take into consideration several factors that may pose greater challenges than for trials limited to the U.S. This article offers practical advice based on TRI’s experience with global trials for managing country assessment and site selection, regulatory matters, safety reporting, clinical supplies, laboratory management, and most importantly, communication.


Proposed Updates to the Common Rule: Addressing a Changing Research Landscape and Its Effect on the Process of Informed Consent

January 2017

The “Common Rule,” also known as the Federal Policy for the Protection of Human Subjects is the basic policy that governs all federally-supported research conducted today. Twenty-five years have passed since the Common Rule was codified, and since that time, much has changed, particularly when it comes to technological advancements that make areas like research genomics, bio-imaging, and informatics possible.


Saving Time in Clinical Operations through Data Visualization

January 2017

Data visualization tools are used in a number of professional fields such as network engineering and finance to easily view how some data points relate to others. Did you know that these tools can also be used in clinical research? Data visualization tools can enable researchers to identify trends and observe interaction between specific factors within data sets. Data visualization tools provide insight that typical data management software cannot offer.


 2016


Precision Medicine:
An Overview of Healthcare’s New Wave and Future Hope

September 2016

Development of precision medicine has increasingly become a focal point across a range of specific disease areas with the goal of improving patient outcomes. Traditional “one size fits all” approach, generally comprising most of today’s treatment and prevention regimens, in reality achieves only a “one size fits most” status and can leave considerable gaps that many individuals fall through.


An Auditor’s View of Compliance Challenges in Resource-Limited Clinical Trial Sites

September 2016

More and more clinical trials are being conducted in resource-limited regions of the world for many reasons, including a higher concentration of willing and eligible participants; existence of rare and aggressive diseases in certain regions of the world; and socio-economics needs of certain regions to treat, cure and eradicate these diseases, etc. As a result, pharmaceutical companies often collaborate with U.S. government agencies, global health organizations, private charities, contract research organizations (CROs) as well as local and regional governments to launch and execute clinical trials to prove safety and efficacy of their products in these regions and markets.


Can You Hear Me Now? Why In-Person Interactions Continue to be a Cornerstone of Outreach Programs in Clinical Research

September 2016

Outreach programs are communication and training platforms with specific goals or messages and target audiences. Such programs are vital components of clinical research enterprises. Used at various stages in clinical research, outreach programs can facilitate participant recruitment, streamline processes for multi-site trials, promote regulatory compliance, and align stakeholder coordination activities, with dramatic impact on trial success. As a Contract Research Organization supporting several of the largest global clinical research portfolios, TRI’s expertise in designing and implementing outreach programs has significantly benefitted our clients.


TRI Awarded Best Woman-Owned Business Enterprise CRO+ by GHP Magazine

September 2016

TRI is the recipient of a 2016 International Life Sciences Award for Best Woman-Owned Business Enterprise (WBE) CRO+ by Global Health and Pharma (GHP). This merit-based award recognizes the innovation, dedication, and commitment shown by life science professionals and firms across the globe. Nora Lee, President and CEO, discusses the company and its innovative service offerings.



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