Beyond Diversity: Reaching all Patient Populations in Clinical Research

-By Howard Chipman, MD, IMA Principal Investigator, St. Petersburg, Florida

There has been considerable discussion about “diversity in clinical trials” so I thought I would explore these concepts and think about what that really means.  When the medical community investigates a new drug, we want to know the safety and effectiveness profile of that drug for the population that will be using it.

The FDA has issued guidance that promotes the inclusion of diverse populations in clinical trials to better understand the risk and benefits across all groups. The traits of these groups can include gender, race, ethnicity, age and location of residency.

We should consider more than that to ensure true diversity in clinical research. Non-demographic traits include patients with organ dysfunction, co-morbidities, disabilities, weight extremes and diseases of low prevalence. 

Location. Location. Location.

Since the diversity of study participants often reflect the demographics of the study location, having locations in different socioeconomic and ethnic areas could help generate a more representative population.

What is unknown is the impact of those differences on these various groups and if they are significant for that particular new drug.  Another concern is the possible increase in the size and complexity of trials if different subgroups are identified.

Therefore, it should be a priority to increase the diversity of study participants in clinical trials so that trials approximate the population to be treated, leading to more refined and improved FDA recommendations.   Other approaches to consider include:

        • Broadening eligibility criteria
        • Increasing flexibility of visit windows
        • Making the process more convenient for participants
        • Offering “virtual” visits

Finding the right study site

While many of these changes need to be made by the study designer, study sites can prioritize their efforts to recruit from a diverse population by trying to obtain a representative sampling.

The IMA Group has a large footprint of offices, both in urban and rural areas, that see a significant volume of diverse individuals on a weekly basis.  This allows us to reach clinical trial participants from every background, making sure that clinical trials are an available choice to everyone, everywhere, and enroll enough that mimic the population demographics.

IMA’s large geographic footprint allows an expanded reach to access these diverse populations.  This reach fosters a greater likelihood of achieving a more robust diversity among the clinical study participants and thus, helps to ensure better outcomes from the study.

Clinical Trials in the Time of COVID-19

by James Greenwald, MD, PhD, Principal Investigator, IMA Clinical Research, New York

Managing clinical trials during the COVID-19 outbreak has been challenging, especially in New York City.

The first COVID-19 outbreak severely affected New York State and most specifically the New York City area.  All of us who lived in New York City in March and April experienced the incessant sound of ambulance sirens in response to citizens sickened with the virus and daily news stories of overwhelmed hospitals with these patients.  In early March we closed our research facility to participant visits in order to both protect our participants and medical staff from unnecessary exposure to the virus.  We had to take multiple factors into consideration before making this decision.  First, New York, unlike most other American cities, relies heavily on public transportation (ie. Buses and subways).  Because of the density of bus and subway riders, our staff and participants did not want to use public transportation because of the potential safety risks. Thus, our participant visits became virtual.  Virtual visits can feel very different;  however, we adapted quickly and were able to keep in contact with our participants, record symptomatology, and perform study drug accountability.

New York and its citizens suffered greatly but by early June the city and state was able to get the virus under control and achieve the lowest infection rate in the US. It was at this time our participants and staff felt comfortable traveling on public transportation and we opened our clinic to participant visits. Since opening, we have followed strict CDC guidelines for the use of PPE and physical distancing.  We have re-organized our facility to ensure the quality of the indoor air, cleanliness of surfaces, and strict use of PPE and physical distancing.  We also strictly monitor out of town visitors to ensure none are coming for areas of high infectivity without following quarantine guidelines.

We continue to be flexible and prioritize our participant and staff safety. New Yorkers and our clinic are committed to solutions that promote low COVID-19 infection rates.

Joining the IMA Leadership Team during the COVID-19 Pandemic

By Michele Aguirre, Regional Director of Clinical Operations, IMA Clinical Research

I joined IMA in March 2020 as the Regional Director for Clinical Operations during a turning point in history, the COVID-19 pandemic.  I have been working in the field of clinical research for over 20 years and love that I am part of something that has the ability to impact lives by developing future medications. Most of my career in clinical research has been on the clinical operations side, but I did spend a few years working in regulatory and quality assurance roles.  I started my research career path as a study coordinator and then moved through various leadership positions within the industry. 

Joining the IMA group during this time has really impressed me as our organization really put patients first by designing safe ways for our patients to continue to get access to healthcare and for our research patients continue their current study participation. COVID-19 has brought us many operational challenges in our organization but we have worked as a team to create processes that minimize the impact at our research sites/facilities.  This includes policies and procedures that screen for COVID-19, enhanced cleaning and disinfecting protocols, and virtual appointments when possible to promote the health and safety of our study participants and staff.

We continue to communicate with our on-trial and potential volunteers and are providing them with information about how they can stay safe and healthy during this time. We are also preparing them for what to expect when they visit our facilities, given our enhanced screening and safety measures. Our employees receive frequent updates on the COVID-19 situation.

At IMA our priority remains to keep our volunteers and employees safe and well-informed while doing what we can to help minimize the potential spread of the coronavirus. We will continue to dedicate significant resources and efforts to mitigate the risks while still ensuring business continuity to the greatest extent possible.

 

 

Clinical Research Studies during the COVID-19 Pandemic Public Health Emergency

Defining the New Normal in Clinical Research to Support the World’s 336,747 Research Studies

by Jennifer Goldfarb, MSN, RN, CCRP

As of April 21, 2020, according to clinicaltrials.gov, there are 336,747 research studies registered in all 50 states and 210 countries throughout the world. Clinical research is a delicate ecosystem within the healthcare system that can easily be advocated for as an essential healthcare service. It is a highly complex, intensely regulated and regimented environment. It is a critical component of healthcare that drives scientific and medical advances to promote health and treat illness. This environment has suffered unprecedented disruption and chaos during this pandemic. While we hunker down in our homes, waiting for this storm to pass, clinical research conduct is being adapted, paused, and even discontinued, in every therapeutic area.

What is the impact of potentially disrupting 336,747 research studies across the globe due to the challenges caused by the pandemic? These challenges include necessary quarantine, clinical research site staff and study participant COVID-19 infection, site closures, supply chain disruption, travel limitations and stay-at-home orders. The impact will vary for each individual study, based on the nature of the research study, the disease and investigational product being studied, the geographical location of the study site, and other details. The impact on our public health in the years to come is unknown; however, it is hard to believe that it will not be felt. The way we adapt now may act to minimize harm, both now and in the future.

How do clinical research sites adapt to minimize the disruption, while protecting the safety of clinical research participants and maintaining the integrity of the research? On March 18, 2020 the FDA released Guidance for Industry, Investigators, and Institutional Review Boards to help address the many concerns related to the conduct of clinical research during the COVID-19 pandemic. They updated this guidance to include a Q&A appendix on April 21, 2020.

Dr. Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs, emphasized that clinical researchers must prioritize the study participant’s safety. Dr. Shah said that we must find the delicate balance of supporting ongoing clinical research conduct in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.

The IMA Clinical Research Site Network, with sites located across the country conducting research in multiple therapeutic areas, has always prioritized and ensured study participant safety and quality data collection and reporting. This has been achieved through dedicated and experienced investigators and staff, expert project management, and quality oversight. We do not lose sight of these priorities, even in the thick of COVID-19, with its significant and seemingly unending impact on life as we once knew it to be. We instead have risen to the challenge, like many of our clinical research colleagues throughout the world, going above and beyond to ensure that we do everything possible to protect participant safety and the integrity of our studies.

IMA Clinical Research is partnering with Sponsors, CROs, and Institutional Review Boards to evaluate each study individually, and adapt to best support the needs of each study and its participants. Advanced planning and effective communication have been the keys to our success. Study visit schedules, based on the study protocol’s requirements for safety and efficacy assessments, are being anticipated far in advance, with clear contingency plans in place. Study visits are not only important for their required assessments but also because they may provide an opportunity to supply study participants with study drug, supplies, and support. We have worked with Sponsors to operationally support a protocol modification to allow for phone and virtual visits. We have put new processes in place to protect participant safety, including screening procedures recommended by the CDC. We have adjusted participant visit schedules, in consultation with our Sponsors, to eliminate unnecessary in-person visits. We have accommodated numerous remote monitoring visits, facilitated by the use of our CTMS system, CRIO, that allows for eSource and eRegulatory documentation. These are just a few examples of what IMA Clinical Research has done to support our study participants and research studies over the past 6 weeks. We add to this list every day, without hesitation, and will continue to do so over the coming months, and years, as needed.

While there are still many unanswered questions about the impact of COVID-19, one thing that seems clear is that the return to normal will be gradual. It will look different from the past, COVID-19 having forever changed our “normal”. Clinical Research sites must plan now to be prepared for this ongoing adaptation to our new normal so that we can continue to conduct clinical research. This is essential because there is one thing that will not change. We will always need clinical research to support scientific and medical advances to promote health and treat illness.

About the Author: Jennifer Goldfarb is a clinical research industry expert and leader with over 20 years of nursing, clinical research operations and management experience. She is the VP of IMA Clinical Research.