Last year, medical research has undergone an unprecedented transformation. From March 1, 2020 to April 26, 2020, more than 80% of clinical trials were suspended (Pennsylvania State University). Understandably, most of the ongoing trials are focused on Covid-19. In just one year, the pandemic has fundamentally changed the way the research community operates—allowing clinical trials to be suspended, reassessed, or continued virtually. With the increase in vaccination rates, suspended trials are restarting, and new trials are beginning. Navigating the current environment in the context of new variants and the Covid-19 agreement may make reopening or starting clinical trials seem like a daunting responsibility. Consider these four factors for a successful return to the study.
Assess staffing needs and challenges
Before Covid-19, the lack of clinical trial coordinators and high turnover rates were already a challenge. The pandemic has further disrupted employment through redistribution, retirement, recruitment freezes, and even higher employee turnover. This pain point was evident in our recent survey of research coordinators and staff. According to reports, the biggest obstacle to restarting trials and starting new trials is ensuring the right staff.
The shortage of clinical trial coordinators is not just a human resource issue. The coordinator is critical to the recruitment and participation of participants, the quality of the data, the completeness of the results, and the overall success of the research. Investing in this role will help stakeholders achieve research goals and conduct research trials on time and on budget.
Professionally recognizing the position of clinical trial coordinator and appointing a dedicated coordinator will help reduce errors and improve the accuracy and quality of research. Given that the responsibilities of a clinical trial coordinator range from negotiating budgets and completing required paperwork, to recruiting participants, guiding research visits, and involving participants in trials, it is no wonder that the turnover rate is high. By dividing some responsibilities and outsourcing management and compliance tasks, the coordinator will be able to focus all of his attention on managing the experiment.
Ensuring a more diverse research population
It is not surprising that the lack of diversity in clinical trials is an ongoing problem in the medical community. According to a 2018 report, although whites make up 67% of the U.S. population, they make up 80% of study participants. In contrast, blacks and Latinos accounted for 13% and 18% of the U.S. population, respectively, but only accounted for 1-5% of trial participants (Advisory Committee). Many other ethnic and racial minorities were also excluded from the trial, including persons with disabilities and people of remote age.
To solve this problem, the US Food and Drug Administration (FDA) updated its clinical trial recruitment guidelines during the pandemic, especially to meet the more diverse needs of the trial population. These guidelines allow the inclusion of individuals with comorbidities, disabilities, and broader weight ranges, as well as increased population diversity and outreach to communities of color.
As the inclusion and qualification requirements expand, please consider the impact on protocol design and methodologies. In a survey conducted by BRANY, 37% of clinical trial professionals stated that creating research materials and consent forms in multiple languages and through multiple delivery methods (video, mobile devices, social media, and email) is the most important way to increase diversity. One of the successful methods is in their clinical trials.
Positive steps to ensure diversity:
- Talk to the research sponsor as early as possible to learn about diversity initiatives
- Share updated FDA guidelines Help increase diversity
- Utilize the diverse programs of hospitals and academic medical centers to promote and recruit clinical trials
Keep communications up to date and compliant
In this Covid era, communication with trial participants has changed dramatically, including virtual patient monitoring, home visits, and online consent forms. Ensure that all new and existing employees have the resources and training required for virtual and face-to-face communication with participants, IRB-approved consent, and comply with the Covid agreement. Any research changes that modify the research design or affect the risk of participants may also need to be reviewed by the IRB.
It turns out that during a pandemic, telemedicine access is a huge asset that can ensure the safety of participants and allow active trials to continue. If there are still restrictions on activities in medical institutions, it may be difficult for researchers to meet the research expectations of recruiting new trial participants. During non-pandemic periods, recruiting new research participants can be challenging. It is necessary to show potential participants the experiment, obtain consent, and involve them when working remotely, which adds to the complexity of the process. If the process seems difficult, participants may be reluctant to participate.
Consider budget implications and planning
According to the results of a new BRANY survey, nearly a quarter of the respondents said that adequate funding is one of the biggest challenges in starting a new experiment. With staff turnover, changes in agreements, and more than a year of suspension of trials, most budgets will not simply start where they left off. Even if a study is not for Covid-19, the new pandemic agreement will increase the cost of each trial. Personal protective equipment (PPE), enhanced Wi-Fi for remote testing, video conferencing services, and home visit transportation all incur additional costs. Keep in mind the cost of training or retraining new employees and returning employees, as well as the employee time required to carry out activities such as remote monitoring by research sponsors or CROs.
Before restarting or starting a new clinical trial, review the existing research budget to determine any additional costs that need to be paid. For ongoing trials, please contact your research sponsor to begin the process of revising the current budget.
go ahead
As the country enters the next phase of the pandemic, researchers are very much looking forward to resuming the suspended research and starting new research. Following this, Covid-19 has left the research community with a lot to reorganize. Keeping these precautions in mind will help institutions and laboratories overcome potential obstacles and successfully return to research.
Photo: Wach, Getty Images
