Last year, medical research took an unprecedented turn. Between March 1, 2020 and April 26, 2020, more than 80% of clinical trials were suspended (Penn State). The majority of trials that continued were understandably, focused on Covid-19. In just one year, the pandemic fundamentally changed how the research community operates – leaving clinical trials to pause, re-evaluate or continue virtually. As vaccination rates increase, suspended trials are re-opening and new trials are starting. Navigating the current environment against the backdrop of new variants and Covid-19 protocols may make re-opening or starting clinical trials seem like a daunting responsibility. Consider these four factors for a successful return to research.
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Paddy Mullen Paddy Mullen joined BRANY in 2010 and reports directly to BRANY’s Board of Directors. Prior to joining BRANY Ms. Mullen founded DiscoveryOrtho Partners, a consulting and advisory firm focused on the orthopedic sector. Ms. Mullen developed her expertise in orthopedics and research starting in 1999 as Executive Vice President at Hospital for Special […]
The lack of clinical trial coordinators and high turn-over rate was already a challenge before Covid-19. The pandemic further disrupted employment through reassignment, retirement, hiring freezes, and even higher staff turn-over. This pain point was evident in our recent survey of research coordinators and staff where it was reported the biggest barrier to reopening trials and starting new ones is securing appropriate staff.
The shortage of clinical trial coordinators is not just a human resource issue. Coordinators are vital to the recruitment and engagement of participants, quality of data, integrity of results, and overall success of the research. Investing in this role will help stakeholders meet the aims of the research and keep research trials on time and on budget.
Professionally recognizing the clinical trial coordinator position and appointing a dedicated coordinator will help reduce errors and improve the accuracy and quality of a study. Given that clinical trial coordinators’ responsibilities range from negotiating budgets and completing required paperwork, to enrolling participants, shepherding study visits, and keeping participants engaged in trials, it is no wonder that turnover is high. By segmenting some of the responsibilities and outsourcing administrative and compliance tasks, coordinators will be able to focus their full attention on managing the trial.
Ensure a More Diverse Study Population
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
It should come as no surprise that the lack of diversity in clinical trials is an ongoing issue in the medical community. According to a 2018 report, while whites make up 67% of the U.S. population, they represent 80% of research participants. Conversely, Black and Latinx individuals represent 13% and 18% of the U.S. population, respectively, yet only account for 1-5% of trial participants (ACRP). Many other ethnic and racial minorities are also excluded from trials including those with disabilities and outlying ages.
To combat this issue, the U.S. Food and Drug Administration (FDA) updated clinical trial enrollment guidelines during the pandemic, specifically to address the need for greater diversity in trial populations. These guidelines allow for the inclusion of individuals with comorbidities, disabilities, and wider weight ranges, as well as increasing demographic diversity and outreach to communities of color.
As inclusion and eligibility requirements are broadened, consider the effects on protocol design and methodology approaches. In a survey conducted by BRANY, 37% of clinical trial professionals say creating study materials and consent forms in multiple languages and through multiple delivery methods (video, mobile devices, social media, and email) is one of the most successful ways of increasing diversity in their clinical trials.
Proactive Steps to Ensure Diversity:
- Speak with study sponsors early to learn about diversity initiatives
- Share updated FDA guidelines to help to increase diversity
- Tap into diversity programs at hospitals and academic medical centers to promote and recruit for the clinical trials
Keep Communications Current & Compliant
In this Covid era, communications with trial participants have changed drastically with virtual patient monitoring, at home visits, and online consent forms. Ensure all new and existing employees have the resources and training they need to communicate with participants both virtually and in-person, IRB approved consent forms, and are following Covid protocols. Any changes to the research that modify the study design or impact risks to participants may also require review by an IRB.
Telehealth visits proved to be a tremendous asset during the pandemic to keep participants safe and allow active trials to continue. Where restrictions remain in place to limit activities within healthcare facilities, researchers may struggle to meet study expectations for enrolling new trial participants. Recruiting new study participants is challenging when not operating in a pandemic. Having to present a trial to a potential participant, obtain consent, and keep them engaged while working remotely adds another level of complexity to the process. Participants may not be open to participation if the process seems difficult.
Consider Budget Implications & Planning
According to results from a new BRANY survey, nearly one in four respondents said sufficient funding was one of the biggest challenges to starting new trials. With staff turnover, changes in protocol, and more than a year of paused trials, most budgets will not simply pick up where they left off. Even if a study is not specific to Covid-19, the new pandemic protocols increased costs to every trial. Personal protection equipment (PPE), enhanced Wi-Fi for remote trials, videoconferencing services, and transportation for in-home visits will all require additional costs. Keep in mind the cost of training or retraining new and returning employees as well as the staff time required to accommodate activities such as remote monitoring by the study sponsor or CRO.
Before reopening or starting a new clinical trial, review existing study budgets to determine any additional costs that will need to be covered. For ongoing trials, contact your study sponsor(s) to begin the process to amend the current budget.
Moving Forward
As the country navigate the next phase of the pandemic, researchers greatly anticipate returning to paused studies and starting new ones. In its wake, Covid-19 left the research community with much to reorganize. Keeping these considerations in mind will help institutions and laboratories overcome potential barriers and achieve a successful return to research.
Photo: Warchi, Getty Images
Paddy Mullen joined BRANY in 2010 and reports directly to BRANY’s Board of Directors. Prior to joining BRANY Ms. Mullen founded DiscoveryOrtho Partners, a consulting and advisory firm focused on the orthopedic sector.
Ms. Mullen developed her expertise in orthopedics and research starting in 1999 as Executive Vice President at Hospital for Special Surgery (HSS) in New York City, the leading orthopedic hospital in the U.S. At HSS, Ms. Mullen was instrumental in the creation of HSS Ventures, a technology development company focused on venture capital investment, clinical research, product development and licensing in both rheumatology and orthopedics.
Prior to joining HSS, Ms. Mullen served as Senior Vice President of Business Development for Continuum Health Partners in New York City. Ms. Mullen received a Bachelor of Arts degree from the University of Notre Dame and an MBA from Babson College.
