The ClinicaTrials.gov website lists over 3,000 active and recruiting clinical research studies involving COVID-19 or SARS-CoV-2. The National Institutes of Health (NIH) have updated their guidelines for handling and processing specimens associated with coronavirus disease. The Centers for Disease Control and Prevention also updated their guidance. Likewise, research sites and laboratories have updated their policies […]

Busy clinical investigators who have additional patient care duties can find themselves in a perpetual state of multitasking. It is common for investigators to delegate certain study-related tasks to their study staff, or to colleagues. This can include study coordinators, study nurses, pharmacists, among others. Sometimes investigators run into problems when the people to whom […]

FOR IMMEDIATE RELEASE August 2, 2022 BRANY ACQUIRES COMPLIANCE SOFTWARE PROVIDER TECH SOFTWARE Tech Software’s offerings will round out a growing portfolio of compliance and research solutions (Lake Success, NY) — BRANY announced today its acquisition of Tech Software, a leading provider of SaaS compliance solutions in the higher education, academic medical center (AMC), hospital, […]

Initiatives by the FDA, NIH and other regulatory agencies that have urged investigators and sponsors to diversify study populations have been just that: suggestions and recommendations. But a new report by the National Academies of Sciences, Engineering and Medicine is suggesting that regulatory agencies add some bite to their guidance. The organization is recommending enforcement […]

The National Institutes of Health (NIH) has released two resources to the research community that aim to prepare institutions for the implementation of the NIH Data Management and Sharing Policy, which goes into effect in January 2023. The first resource, “Informed Consent for Secondary Research with Data and Biospecimens: Points to Consider and Sample Language […]

The FDA recently issued a warning letter to a Florida university’s principal investigator regarding a contract testing lab’s improper handling of data. The letter outlines significant deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API), including claims that a student analyst falsified data. Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic […]

While much of the national dialogue about diversity in clinical trials has focused on the inclusion of underserved populations, communities of color, and women, recent FDA guidance turned its attention to the inclusion of older adults — those over 65 years of age — in clinical research. While most cancer trials do not have an […]

The U.S. Food and Drug Administration (FDA) recently issued three final guidance documents regarding cancer clinical trials. The announcement supports the goals of the so-called “Cancer Moonshot” initiative to facilitate research and advances in cancer prevention, diagnosis, and treatment. Although the guidance is directed primarily at industry sponsors, research sites should be aware of them […]

Over the last two years, particularly with the disruption caused by the pandemic, the use of digital technologies in health care has increased exponentially. COVID-19 has had a huge global impact on clinical trials from outright trial cancelations to challenges in recruiting participants. Necessary restrictions on travel and physical contact limited research sites’ abilities to […]

As we approach our third year of the global COVID pandemic, we take a moment to reflect on the impact it’s had on health care in general and clinical research in particular. The last two years have laid bare the challenges of equity and access, as well as the importance of leveraging technologies to improve […]

The public conversation regarding equity, access, inclusion, and diversity in clinical trials covers a wide spectrum of underrepresented communities, including race, ethnicity, socioeconomic status, sexual orientation, and gender identity. One population that receives less attention are patients with physical or cognitive disabilities. Including patients with cognitive disabilities in clinical trials poses special challenges. Among the […]

Among other things, 2021 will be known as the year of The Great Resignation, or in many sectors, the great retirement. Record numbers of employees left their jobs. Nearly four and a half million Americans left their jobs in September 2021, the highest number on record since the Bureau of Labor Statistics began collecting data 20 years […]

Pediatric clinical trials for the COVID-19 vaccine have started in the United States for children as young as six months. The COVID-19 vaccine made by Pfizer-BioNTech is already authorized for emergency use in anyone 12 and older in the U.S., Canada, and the European Union. The company is seeking FDA approval for use of the vaccine […]

International organizations such as the World Economic Forum have been researching and analyzing the “future of work” and its implications for economies. Likewise, consulting firms have been predicting the important training needed to prepare workforces for new labor markets. Surveys of company leaders indicate an increasing need for employee upskilling and retraining. The COVID pandemic […]

The National Institutes of Health (NIH) announced this week that they were joining forces with the Food and Drug Administration (FDA), ten pharmaceutical companies and five non-profit organizations to accelerate the development of gene therapies for rare diseases. The new public-private partnership, called the Bespoke Gene Therapy Consortium, aims to overcome obstacles and streamline the […]

BRANY announced several new hires as almost 50% of respondents in a recent BRANY survey report they expect the level of clinical trial activity to return to pre-pandemic levels by 2022. The influx of new talent is aimed to ensure BRANY continues to serve the evolving needs of our customers looking to restart or open […]

The FDA recently issued a notice to a California-based principal investigator regarding non-compliance with the requirement to submit clinical trial results information to the ClinicalTrials.gov data bank. The requirement, part of the Food and Drug Administration Amendments Act of 2007 (FDAAA), was designed to improve clinical trial transparency. Although the Final Rule for Clinical Trials […]

In March 2020, as governments around the world were issuing large-scale lockdowns, health facilities shifted their efforts to addressing critical needs of patients while trying to maintain the safety of staff. Clinical trials ended or were paused, and researchers allocated their attention and resources to understanding and managing the novel coronavirus. To assist researchers, IRBs, […]

A Medicare coverage analysis (MCA) for clinical trials evaluates which tests, procedures, and interventions will be associated with a clinical trial. This analysis results in a budget and plan for invoicing third party payers and sponsors. Clinical trials for devices differ from interventional trials for drugs in a few key ways that can impact the process […]

Research related to COVID-19 has increased awareness in the community about the role of the institutional review board (IRBs) to protect the rights and welfare of research participants.  The regulations and guidelines in place to ensure the safety of research participants cover a wide range of areas that need attention.  In addition to evaluating a […]

In March 2019, we published an article addressing the threat of burnout among clinical research coordinators. A year later, research centers were scrambling to close amid lockdowns. Clinical trials were paused as resources shifted to caring for the surge of patients with COVID-19 in hospitals. Health care providers, including clinical research professionals, were thrust into […]

When investigators embark on designing, writing, and initiating the clinical trial, their responsibilities are just beginning. The FDA calls these investigators “sponsor-investigators (SIs)”. A sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. In other words, in an investigator-initiated trial, the […]

Social determinants of health (SDoH) are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes. Collectively, they contribute significantly “to the social patterning of health, disease, and illness,” according to the CDC. Examples of these social determinants include safe and affordable […]

An FDA audit or inspection can occur at any time, and sometimes with very little advance warning. The FDA conducts both announced and unannounced inspections of clinical investigator sites, typically under the following circumstances: to verify the accuracy and reliability of data that has been submitted to the agency; as a result of a complaint […]

One of the most critical first steps in preparing to launch a clinical trial is the development of a budget that covers expenses and compensates the research site. The budgeting process can be complex and requires detailed review of the protocol and a methodical line-by-line attention to detail. A properly negotiated budget ensures that a […]

Members of the U.S. House of Representatives have introduced updates to the 21st Century Cures Act, which was signed into law in December 2016. The proposed legislation coincides with a detailed concept paper the White House published Tuesday in Science Magazine outlining their vision for the new research agency. The 21st Century Cures Act, known as “Cures”, was […]

What does it mean to conduct a virtual clinical trial? What about remote, decentralized, hybrid, or siteless studies?  These terms are sometimes used interchangeably. But there may be value in distinguishing how these models can facilitate recruiting subjects and change the way clinical trials have traditionally been conducted. Advances in mobile and digital health technologies […]

The COVID-19 pandemic had significant impacts on clinical trials and research programs. According to researchers at Penn State, over 80 percent of clinical trials were suspended between March 1 and April 26, 2020, mostly due to the pandemic. The impact was more substantial for government or academic-funded studies than for sponsored trials, according to their […]

To ensure appropriate reimbursement for the services provided to a patient in a clinical trial, research sites must develop a budget for each study. One important step in developing a clinical trial budget is conducting a “coverage analysis,” also known as Medicare Coverage Analysis, sometimes referred to an MCA. An MCA identifies the services for […]

A report[1] published last week by the Centers for Disease Control & Prevention (CDC) shows an increase in anxiety, depression and people’s need for mental health services. According to the survey, between August 2020 and February 2021, the percentage of adults with recent symptoms of an anxiety or a depressive disorder increased from 36.4 percent […]

The Data and Safety Monitoring Board (DSMB) established to monitor COVID-19 vaccines this week announced they were reviewing the clinical trial data submitted by Astra Zeneca for their COVID-19 vaccine. But what is a DSMB, and why is it important for clinical research sites to know? A Data and Safety Monitoring Board (DSMB) is an […]

The United States reached the one-year anniversary of the first confirmed case of COVID-19, on January 15. Even now, as the rollout of vaccinations is underway, institutions are still facing campus and facility closures. We cannot underestimate the impact of COVID-19 on clinical trials and the research community. Institutions have had to refocus resources toward […]

The campus closures necessitated by the pandemic in 2020 forced many research administration officials to adopt virtual meetings to continue their work. People scrambled to set up their home offices, to secure Wi-Fi networks and create accounts on videoconferencing services. The Internet offered dozens of articles on how to improve online meetings to encourage engagement […]

Researchers at Baylor College of Medicine Houston announced this week that they were stopping a clinical trial investigating the efficacy of convalescent plasma therapy in the treatment of patients with COVID-19. The reason, according to the principal investigator, was that statisticians had deemed the NIH-funded study to be futile. In other words, even with more […]

The disruption of clinical research as a result of COVID-19 cannot be overstated. Virtually everything about developing protocols and starting clinical trials has been upturned. In some cases, trials have been closed indefinitely. Others have been delayed or streamlined. Much of the interaction, such as IRB review meetings, has been shifted online, decentralized or outsourced […]

We know we are not alone when we say we are happy to put 2020 behind us. It was a challenging year for everyone, and we look forward to better days ahead. Despite the difficulties that the research community faced, we witnessed remarkable flexibility, resilience and creativity in dealing with significant hurdles. Last year lent […]

Increasing Diversity in Clinical Trials

The FDA issued guidance in November aimed at enhancing diversity and encouraging inclusivity in medical research, specifically in the development of medical products. FDA Commissioner Stephan M. Hahn, M.D., wrote that “in order to promote public health, it is important that people who are in clinical trials represent the populations likely to use the potential medical […]

Critical Considerations for Remote Clinical Trials

Even as research centers and academic institutions re-open after shutdowns due to COVID-19, many researchers are looking at ways to use remote technologies in their clinical trials. In South Carolina, for example, nicotine addiction researchers[1] are examining how to enroll smokers in their studies. They are evaluating e-consents, online surveys and questionnaires, as well as […]

How COVID-19 Has Impact Clinical Trial Budgeting

As COVID-19 swept across the United States earlier this year, many research centers found themselves pausing or stopping clinical trials and shifting their work from an office or clinic to their homes. Clinical research staff pivoted their focus to support the COVID-19 response, or to launch critical studies focusing on COVID-19. As some research staff […]

Investigators Face Challenges in Writing Research Protocols in the Age of Remote Working

While some research institutions are slowly re-opening their campuses, many investigators and their staff are still working remotely from home, at least part time. This has had a significant impact on both industry sponsored and investigator initiated clinical trials. Learn how to continue protocol writing even when working remotely. https://bit.ly/2QoW1NW

Telehealth, Clinical Research and Informed Consent

By most any measure, one of the biggest impacts that COVID-19 has had on the practice of medicine is the shift toward more telemedicine visits. Although the practice of delivering health services over the phone or the Internet has been around for some time, it wasn’t until the pandemic forced communities to close that clinical […]

Lessons Learned (so far) in COVID-19

Even as communities start the process of evaluating re-opening, many experts believe that a new normal will be with us for a long time. Physical distancing, face masks and ubiquitous alcohol gel will be part of daily life. The risk of recurrence spikes also looms ahead and threatens a return to stricter “stay at home” […]

Chart Review Studies During and After a Pandemic

The current global pandemic combined with electronic medical records and data visualization technologies have resulted in unprecedented advances in real-time tracking of SARS-CoV-2, the virus that causes COVID-19, across countries, states and local communities. As the situation evolves, there will be ample opportunity and increased need for both retrospective and prospective COVID-19 research studies that […]

BRANY’s IRB and Clinical Trial Services teams stand ready to support institutions and sponsors through COVID-19

Research institutions may need to transfer some or all of their clinical trials as they adjust operations in response to the coronavirus pandemic. BRANY, a national organization that provides IRB review and clinical trial start-up services, announced today that its team of experts is standing ready to support institutions impacted by COVID-19. Extraordinary measures, from […]

Preparing for COVID-19 Impacts on Research Institutions

The rapidly evolving federal, state and local policies regarding COVID-19 are impacting every walk of life in the United States and around the world. Companies, as well as academic and government researchers, have pivoted their focus on vaccines and possible treatments for the novel coronavirus. Health and research institutions are trying to keep up with […]

Taking Advantage of NIH Funding Increases for Investigator-Initiated Clinical Research Requires Thoughtful Protocol Writing

Earlier this year, the National Institutes of Health (NIH) announced the approval of a budget appropriation bill for funding through September 2020. In it, the NIH receives $41.68 billion in funding, an increase of $2.6 billion from FY 2019. For NIH, the new budget appropriation includes $500 million for the All of Us precision medicine study and a […]

Challenges and questions remain as the one year anniversary of the implementation of the Revised Common Rule approaches

One year has passed since the implementation of the Revised Common Rule, and many challenges and questions remain. While IRBs wait for promised guidance to materialize, we are left to interpret various aspects of the rule ourselves. This has resulted in variability across IRBs in how the new requirements are interpreted and operationalized. Variability in […]

The Critical Issues Sites Need to Track During a Clinical Trial – Part Three – Enrollment

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful tracking ensures your research organization remains compliant and that your site is compensated properly for the study. […]

The Critical Issues You Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful monitoring ensures your research institution remains compliant and that your site is compensated properly for the study. […]

The Critical Issues Sites Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful tracking ensures your research organization remains compliant and that your site is compensated properly for the study. […]

News Release – BRANY Names Michael Belotto as Chairperson for Social-Behavioral IRB

NEWS RELEASE BRANY (brany.com) has announced that Michael Belotto, PhD, MPH, CCRC, CCRA, will serve as chairperson for their social-behavioral IRB. The SBER IRB is comprised of a multidisciplinary group of experts in social and behavioral research, as well as human subject protection. “Dr. Belotto has been a great contributor to BRANY IRB’s success over the past […]

The Revised Common Rule and New “Concise Summary” Requirements

Our own Linda Reuter offers thoughts on how to meet new ‘concise summary’ requirements on informed consent for clinical trials. https://bit.ly/2JUQ8o3    

New CITI Program Courses and Webinar Help Researchers and Institutions Meet Regulatory Requirements

(Miami, FL) — The Collaborative Institutional Training Initiative (CITI Program), a division of BRANY, has announced new online courses and webinars designed to help research professionals understand and comply with regulatory requirements for clinical trials. The three courses and webinars address critical regulatory requirements: Transitioning research to the Revised Common Rule Protocol registration and disclosure […]

Is This the Right Study for Your Research Site? Five Questions You Should Ask Before Agreeing to be an Investigator

Clinical investigators often have multiple opportunities to participate in sponsored clinical trials. In addition to the professional satisfaction of being at the forefront of therapeutic development, clinical trials present an ability for physicians to offer patients alternatives to treatments they may otherwise be unable to access. While study sites may receive compensation for time and […]

Four Essentials for Clinical Trial Enrollment

Clinical trial enrollment continues to be one of the most vexing challenges for research institutions and sponsors. Despite one quarter of sponsors’ clinical trial budgets being allocated to enrolling participants, half of research sites enroll only one or no patients in studies. Recruiting a diverse patient population is an even bigger challenge, with ethnic minorities, […]

Reconciling Your Clinical Trial Protocol Start-Up Costs and Budget

As clinical trials protocols have grown more complex and more disparate teams are working on different elements of executing them, there is a potential for incongruency between the protocol requirements and the budget. It is critical to engage the stakeholders that will have a part in carrying out the research in the budgeting process. All […]

Burnout Among Research Coordinators — Warning Signs and How to Avoid Them

Let’s face it. Every job has its challenges. However, burnout seems to be at an all-time epidemic level. A recent report from Harvard University highlighted physician burnout as a public health crisis. A keyword search for “preventing burnout” yields 15 million results in Google. In the United States, problems associated with burnout are estimated to […]

Aligning Timelines for Better Coordination

Increased complexity of launching and running research protocols means different teams are contributing their expertise to ensure human subject protection, accurate budgets and successful patient recruitment. It also means that, with so many disparate groups involved, the risk of delays increases. One significant contributor to delays in study start-up is the lack of a common […]

Are Staffing Challenges Affecting Your Institution’s Research Profile?

Many institutions still struggle to recruit and retain the best talent for these challenging positions. A changing regulatory landscape, increasingly complex protocols and a litany of deadlines all contribute to a stressful environment for these employees. Additionally, salaries have remained largely stagnant, creating a general sense of disengagement. Staff turnover can lead to interruption in […]

The Revised Common Rule and Informed Consent: Public Posting

Public Posting An important provision in the Revised Common Rule is the requirement to post, to a publicly-available federal Web site, a copy of an IRB-approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency. The Office for Human Research […]

The Revised Common Rule Compliance Dates and Transition Provision Draft Guidance

The Department of Health & Human Services (HHS) has released The Revised Common Rule Compliance Dates and Transition Provision Draft Guidance. In it, you will find information about transitioning studies to the Revised Common Rule, and answers to frequently asked questions. Our team at BRANY has been closely monitoring the guidance from regulatory agencies and is […]

The Revised Common Rule and Informed Consent: Consent Waivers

The Revised Common Rule has a few important changes regarding consent waivers. Under the revised Common Rule, broad consent is provided as an alternative to the informed consent requirements for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. If an individual was asked and refused to provide broad consent, […]

The Revised Common Rule and Informed Consent: Broad Consent

While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of blog posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule. BLOG POST #2 — Broad Consent One […]

The Revised Common Rule and Informed Consent: Concise Summary

While the industry waits for additional guidance on the Revised Common Rule, there are some aspects that are worth taking note now. This is a series of posts that address various important changes for research professionals to keep in mind as they implement the Revised Common Rule. Concise Summary Consent forms must facilitate comprehension by […]

Career Series: Late Career

Experienced Research Professionals Should Consider Mentoring the Next Generation Approximately 10,000 baby boomers will turn 65 every day between now and 2030, according to a study by the Pew Research Center. The field of clinical research is no exception to this enormous wave of research leaders reaching retirement age and exiting the profession. As senior […]

Data Analysis Methods for Qualitative Research: Managing the Challenges of Coding, Interrater Reliability, and Thematic Analysis

The peer-reviewed journal The Qualitative Report has published an article by Michael Belotto, Director of the BRANY Institute of Research Education, entitled “Data Analysis Methods for Qualitative Research: Managing the Challenges of Coding, Interrater Reliability, and Thematic Analysis.” (LINK: https://nsuworks.nova.edu/tqr/vol23/iss11/2/) “While … text books explain the general philosophies of the interpretive tradition and its theoretical groundings, I found […]

Career Series: Mid-Career

Career Transitions: Becoming a Clinical Research Nurse This is part two of a three-part series on research careers. By mid-career, nurses are sometimes looking for new challenges. However, not all nurses are interested in pursuing careers in administration. One path to consider is in clinical research. Nurses play an essential role in the success of […]

Career Series: Early Career

How to Attract and Keep the Best Research Coordinators This is part of a series on career development for research professionals. One of the most challenging responsibilities for an investigator is the recruitment and retention of talented staff, particularly research coordinators. Nationwide, there is a high turnover rate among research coordinators. This disruption in staffing […]