Raritan, New Jersey-based Amici Clinical Research is gearing up for a busy summer as it seeks to conduct up to 15 clinical trials, many of which will be focused on COVID-19 vaccines, treatments, or preventive drugs. In one case, the research site will conduct a critically important Phase 3 COVID-19 vaccine trial. Led by Dr. Robert Falcone, it’s local research sites such as Amici Clinical Research that ultimately recruit the participants and conduct the study leading to a potentially new vaccine or treatment. Much like the life-long surfer waits for the big wave, Dr. Falcone prepares for this “once-in-a-lifetime event or what could also be called an investigator’s career capper. This combination family practice and clinical research site organization, offering research as a care option, is one of at least nine comparable sites in New Jersey.
As COVID-19 has ravaged societies’ health and economies, the race to develop vaccines and therapies has never been more important. Although the biggest drug companies or hot, heavily financed biotech’s often get most of the attention, it is the research site—the clinical trials investigator and their staff—that are the heroes on the ground along with the participants in the studies. COVID-19 will probably put some research sites out of business. That pharmaceutical sponsors suspended many of their clinical trials programs all but dried up the work for many research sites.
But now sponsors are turning the switch back on and sites such as Amici Clinical Research will get very busy very soon.
New Jersey Residents ‘Play their Part’
New Jersey has been hit particularly hard during this pandemic. With 171,981 cases statewide, 12,994 have died making the state second in deaths only trailing its neighbor, New York. Dr. Falcone reports that local residents can do something about this situation; they can get involved and participate in a clinical trial for a vaccine or therapy targeting COVID-19. Dr. Falcone hopes to recruit up to 50 patients for each one of the 15 or so trials his firm will help lead. Depending on the clinical trial, Amici will compensation the participant for their time and travel often ranging from $50 to $120 per office visit. The studies typically last anywhere from twelve to twenty-four months.
The ‘Big One’
Back to the surfing analogy SARS-CoV-2, the virus behind the COVID-19 pandemic is “The Big One” or that wave that a clinical investigational professional like Falcone embraces. “This is my last hurrah (having a successful trial) is a pretty good way to go out,” Falcone declared to the local press ROI NJ. After all, the 66-year old physician has been at it for decades.
Amici Clinical Research Profile
With decades of experience bringing clinical research as a care option to this part of New Jersey, Amici Clinical Research has worked with some of the world’s largest pharmaceutical sponsors from Pfizer, Merck, Allergan and Teva to upstart biotech firms with advanced new treatments for investigation. The firm has conducted many dozens of clinical trials across a range of therapeutic areas through Phase I through 4.
A Solid Site
Based in the center of New Jersey, not far from New York City, Amici combines a family practice with a clinical research center representing a compelling model offering standard care and advanced therapies to those patients that can benefit from novel therapies. With access to 75,000 active patients and a large GI practice, this group prides itself on a patient-centric approach to care combined with advanced research representing 70 years of collective clinical study experience. They apply a ‘lean’ and Six Sigma to support ongoing continuous improvement for high quality levels assurance. According to their positioning on their website, this leads to lower protocol deviation rates, fewer drop-outs, faster enrollment, data entry and query resolution. A brief search for any FDA warning letters turned up negative.
Preparing for A COVID-19 Vaccine Trial
Falcone and the staff at Amici Clinical Research, including four full-time lab employees, prepare for a Phase 3 double-blind clinical trial; neither the participants nor the investigators and clinicians conducting the study will be aware of whether the participants receive a trial vaccine or a placebo, reports Paul Bergeron with ROI NJ. This trial will be like most vaccine trials in that about 50% of the participants will receive the placebo and the other 50% the investigational COVID-19 vaccine. Studies are designed with double-blind attributes to ensure more objective and valid results.
Welcome Heroes: Participant Eligibility Criteria
Dr. Falcone correctly labels those that volunteer to participate in a clinical trial, especially one of the forthcoming magnitude as “heroes.” It will be because of volunteers stepping up to participate in these vaccine trials that progress will be made against COVID-19.
The prospective volunteers must be healthy and no older than 85. They can’t have been diagnosed with SARS-CoV-2 and over the past four months cannot have experienced any cough, shortness of breath. Moreover, they cannot have HIV, Hepatitis B or C or struggle with any immunodeficiency including any autoimmune disease.
Call to Action: If you are based in or near Raritan, New Jersey, consider contacting Amici Clinical Research to consider volunteering in forthcoming COVID-19 vaccine research study. See the link for contact information.