Contributed Commentary by CJ Anderson 

January 18, 2021 | The race to develop a COVID-19 vaccine has shone a light on the sometimes complex process of getting a drug to market like never before, providing an opportune time to examine several common bottlenecks associated with clinical trials and what the industry can do to alleviate them. 

While “Operation Warp Speed” rightfully garners the majority of public attention due to the widespread hope that distribution of a vaccine may signal the beginning of a long-awaited return to normalcy, the drive to rapidly develop a vaccine in record time should focus our attention on common bottlenecks in the clinical trial process, as well as steps that the life sciences industry could take to reduce those bottlenecks and speed up the process for other drug candidates.  

Accessing Patients: Among the first challenge confronting companies conducting clinical trials is the difficulty in enrolling the thousands of qualified patients who are required to obtain adequate data needed for regulatory approval by the U.S. Food and Drug Administration. For example, contrast patient enrollment for a trial for a drug candidate to combat Alzheimer’s disease versus a COVID-19 vaccine trial. The inclusion criteria for patient enrollment in the Alzheimer’s trial may call for patients over the age of 85 who have dementia, while the COVID-19 study may simply require healthy adults over the age of 18 who have not yet tested positive for the novel coronavirus. Needless to say, the pool of potential patients for the COVID-19 trial is far larger and more accessible. Further, potential participants for the Alzheimer’s trial may be even more limited due to the need for these elderly patients to visit sites for assessments and receive the drug. 

However, a portion of this bottleneck can be relieved by embedding clinical trial sites into the community, such as physician offices, long-term care facilities and rehabilitation centers. With an exam room, doctors, nurses and researchers on-site, it would be far more convenient for any patients, especially those with Alzheimer’s or other debilitating diseases, to participate, and much easier for trial sponsors to access the patients needed for a specific trial. 

Screening Patients: A similar but related problem to patient access, the screening process requires trial sponsors to qualify patients for trial participation based on specific inclusion and exclusion criteria for that particular trial. The steps involved with screening patients are generally labor-intensive, manual and slow, and include calling patients, leaving messages, coordinating on-site meetings and conducting screening interviews—adding time and expense to the drug development process. 

To alleviate these issues, more pharmaceutical companies (sponsors) and clinical research organizations (CROs) are turning to artificial intelligence (AI) to screen patients. With AI tools, patients respond to advertisements for a trial, perhaps on Facebook, and then are guided through a question-and-answer session based on the trial’s inclusion and exclusion criteria. If the patient is pre-qualified, the AI software schedules the patient for a visit to the trial site for further conversation with clinicians. 

Educating the Public: There is an alarming lack in public understanding of clinical trials, not to mention the lack of understanding of when trials are available for patients and how patients can benefit. For example, only approximately 3% of adult cancer patients participate in clinical trials, according to a report from the U.S. Institute of Medicine.  

To boost public awareness of clinical trials, sponsors and CROs should consider holding public education sessions in the communities where trials are taking place. Staying with the Alzheimer’s example, trial sponsors might consider holding an open house at a local senior center, inviting community members and potential participants to learn more about the trial.  

Encouraging Physician Participation: Community-based physicians bring real-world perspectives and experiences to clinical trials, resulting in more relevant study questions and a more patient-centered approach to research, according to Duke University. However, just like cancer patients, only about 3% of practicing physicians participate in clinical trials at any one time, according to Duke.  

There are a number of barriers that discourage many physicians from participating, including the additional administrative burden. Further, many smaller medical practices lack the necessary infrastructure, such as staff members who are trained on informed consent, working with Institutional Review Boards, and research ethics. To overcome these barriers, sponsors and CROs can bring the tools and expertise needed to support community physician engagement, letting the physician focus on caring for patients. 

Increasing Patient Diversity: One issue that has received plenty of media attention is the lack of racial and ethnic diversity, in clinical trials, and, specifically, COVID-19 vaccine trials—but that doesn’t make solving this problem any less crucial and urgent. Why is this an issue? Variations in race and ethnicity play a significant role in how people react to drugs, making it imperative that we include significant sample sizes across a diverse racial spectrum. Of course, this is much easier said than done. By creating awareness within patient populations and physician organizations, hopefully we will see a downstream result of patient racial and ethnic diversity.  

Although there are many areas for improvement in the clinical trials process, we should remember that trials often present patients with the opportunity to obtain life-changing therapies that they would not otherwise be able to access. The COVID-19 pandemic has revealed how critical optimizing the clinical trial process is for the future health of humanity. We can start to do it better by solving these bottlenecks.  

CJ Anderson is the President of CCT Research, a Scottsdale based clinical research network with 17 locations across the U.S. CCT Research embeds research studies local physician practices and community care setting. Currently, CCT Research is supporting COVID-19 vaccine, Alzheimer’s, Meningitis and several other studies. He can be reached at cjanderson@cctresearch.com.