The COVID-19 pandemic has disrupted the clinical research industry globally. Despite the constantly changing research environment, pharmaceutical research companies worldwide have planned and initiated over 1300 clinical trials (according to Cytel’s COVID Clinical Trial Tracker) to find vaccines or medications that may slow transmission or treat individuals currently affected by the virus. Although the speed of protocol design and study start up has significantly increased, sponsors and CROs still face a major obstacle: identifying research sites that are able to undertake COVID studies.
To help overcome this challenge, Care Access Research formed the COVID-19 Clinical Trials Alliance. This group is designed to identify capable research sites and match them with sponsors to help accelerate COVID research timelines. Clinical Research IO (CRIO) connected with Vincent Napoli, Director of Business Development at Care Access Research, to learn more about this important initiative.
CRIO: Can you tell us about the COVID Alliance? What is its mission and how did it come about?
Mr. Napoli: The COVID-19 Clinical Trials Alliance is here to foresee and remove the logistical bottlenecks inherent to the clinical trial industry so that we can save lives and end the pandemic. Sponsors typically spend 1-2 months scouting for sites, 1-4 months assessing sites and 2-6 months selecting sites, but studies should not have to wait due to logistics such as these. By creating a registry of sites who are willing to carry out COVID-19 trials and making it available to over 280 CROs and 189 sponsors, we cut away the months-long lag in sponsors getting to a site and also make it quicker for sites to get on COVID-19 trials.
CRIO: What are the benefits of joining the Alliance?
Mr. Napoli: When you register your site to join the Alliance Site List, we share the information you provide with sponsors and CROs working on COVID studies. This information will also help determine which studies are the most suitable for your site. There is also an additional option to join the Alliance Site List and activate an additional benefit, Advanced Sponsor Engagement. In addition to joining the Alliance Site List, the founder of the Alliance will engage with sponsors about your site, meaning they will vouch for your site during identification and assessment processes. Your site will also have the opportunity to work with business development vendors at no cost.
CRIO: So far, how many members do you have?
Mr. Napoli: We are approaching 150 sites and growing.
CRIO: What kinds of COVID trials are you seeing coming down the pike?
Mr. Napoli: Currently, we are seeing a mix of various studies for COVID-19. There has been a shift towards antibody trials and vaccine treatment trials, and a shift away from home testing and diagnostic trials. In addition, numerous studies in pneumonia, SARS-Cov-2 infection trials, SARS, and infection trials are available. The focus of research studies depends on the industry’s current understanding of the virus. If there is a second wave of infection, we should expect to see the focus shuffle again.
CRIO: What are the requirements for sites to take on these trials?
Mr. Napoli: While trial experience is important, we are really looking at clinics or practices with access to patients who have either recovered from or been exposed to COVID. For sites that would like to run a COVID-19 study, but lack the necessary infrastructure, Care Access Research will provide support services.
CRIO: What should sites ask themselves if they want to take on a COVID trial?
Mr. Napoli: Is my staff willing to be exposed to a COVID-positive population? Do I have the patient population or have access to those patients in a neighboring clinic? Do we have a sufficient supply of PPE? How long are the trials and can I randomize the patients within the constraints of the protocol?
CRIO: If a site wants to join, how do they do this?
Mr. Napoli: You can register your trial site online. After completing the online form, we will then get in touch with you about the next steps. You may also contact Vincent Napoli by email (firstname.lastname@example.org) or phone (+1 908-941-2273).
As we continue to navigate this worldwide health crisis, it is vital that the clinical research industry continues to initiate collaborative efforts such as the COVID-19 Clinical Trials Alliance.
For more information on the alliance, click here.