SCRS Advocates for Sites
SCRS Calls on Sponsors to Release Holdback Funds in Response to COVID-19
April 2, 2020
Guidance on Clinical Trial Conduct
FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency
Guidance for Industry, Investigators, and Institutional Review Boards
March 2020 – Updated May 11, 2020
Coronavirus Treatment Acceleration Program (CTAP)
March 31, 2020
Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic
Guidance to Sponsors on How to Manage Clinical Trials During the COVID-19 Pandemic
March 20, 2020
FDA Urges Clinical Researchers to go Virtual in Response to COVID-19 Pandemic
March 18, 2020
Considerations to Support Clinical Trial Monitoring Oversight During COVID-19
March 13, 2020
The Importance of Decentralized Clinical Trials
The Coronavirus/COVID-19 has already had significant impact on the clinical research and all other industries, and on our lives personally and professionally. As we work to develop a vaccine, social distancing has been noted as the most reliable means to reduce the spread of the virus.
Ensuring that clinical trial patients and site staff are safe is of the utmost importance. SCRS has received numerous emails from sites requesting guidance for how to move forward with clinical trial conduct safely and ethically during this pandemic, and how to minimize the impact on their ongoing trials.
COVID-19 has highlighted why it is so important that sites be prepared to conduct clinical trial visits virtually. When a patient cannot physically come to the site or the site cannot physically see patients, as some are not able to do now, it is imperative that a solution is in place to enable sites to continue successfully conducting studies.
We must be proactive in our planning and have a solution in place that enables sites to continue important clinical trial work and keep patients in studies when in-person visits are not an option.
SCRS offers a member benefit which provides access to the education necessary to begin conducting decentralized clinical trials (DCTs) or visits. This training tool is complimentary and available to all sites, regardless of SCRS membership. The training is brief, easy to navigate, and will empower clinical research sites to continue providing needed services to their patients during the COVID-19 pandemic.
If you have not taken the training and become virtual trial capable yet, we encourage you to do so now, before you begin seeing missed study visits or patients wishing to withdraw from a stud.
COVID-19 Partnership Resource Exchange
Many of SCRS’ partners have taken action to support the site community as you navigate the COVID-19 pandemic. SCRS has created the COVID-19 Partnership Resource Exchange so that you have access to these resources in one easy-to-navigate place. Many organizations have created their own COVID-19 resource pages – we encourage you to check out what each company is doing to support the clinical research industry. Check back regularly for updates from new partners.
SCRS Virtual Summit Series
COVID-19 has had a tremendous impact on the clinical research industry. Conferences have been cancelled, travel restrictions are increasing and additional barriers are being experienced by sites, sponsors, CROs and patients alike.
SCRS recognizes the need for continuing education opportunities in light of the extensive clinical research conference cancellations due to COVID-19. In response, we have created an
8-part, complimentary Virtual Summit Series which will provide the opportunity to obtain needed education and gain a deeper understanding of how this globally adverse situation is affecting sites.
Topics covered will include site preparedness for COVID-19, business development, decentralized clinical trials (DCTs), disaster planning, becoming the site of choice and more. Contact hours will be available for each webinar.
Sponsored by VirTrial
Questions and Answers from 03/24/2020 Site Panel – COVID-19 Preparedness – What is Happening Now
Questions and Answers from 3/31/2020 Webinar – Business Continuity: GCP Compliant Clinical Trials
Questions and Answers from 4/9/2020 Webinar – Relationship Building and How to Get More Business
Questions and Answers from 4/16/2020 Webinar – COVID-19 Site Impact Panel, Part 2: A Reflection and Best Practices for the Future
Questions and Answers from 4/21/2020 Webinar – A Good Site is Not Hard to Find
SCRS Talks Interview Series
Our partners have important updates that SCRS knows you would love to hear about, with many topics addressing COVID-19 related challenges. These short interviews will provide insight into key industry topics, current events, new perspectives, and exciting opportunities. Click the link below to visit the SCRS Talks page.
Statement from the President
We are all in a trying time as we navigate the COVID-19 pandemic. Stay-at-home orders, overwhelmed hospitals, businesses challenged to keep their doors open and more continue to impact each and every one of us. With the world increasingly looking to the clinical research industry for needed solutions, it is the site community who is playing a pivotal role to quickly and safely produce an effective COVID-19 vaccine.
Sites play a crucial role in discovering cures and vaccines that ultimately save and enhance lives. Your innovation, dedication and knowledge are needed now more than ever. SCRS celebrates clinical research sites and other industry players as we work to create medicines that will protect and vaccinate against COVID-19 and other viruses and diseases.
The COVID-19 pandemic has highlighted the importance of telemedicine, as many organizations adopt virtual elements to minimize the impact on their clinical trials. When a patient cannot physically come to the site or the site cannot physically see patients, as many are not able to do now, it is imperative that we have a solution in place that enables us to continue successfully conducting studies. In today’s environment it is critically important that sites be prepared to conduct decentralized clinical trials (DCTs). SCRS remains committed to the site community by providing access to the training required to incorporate virtual/remote elements into trials through our complimentary Virtual Trial Capable training program.
In addition, SCRS recently issued a press release calling on sponsors to release holdback funds in an effort to help sites remain sustainable in response to COVID-19. Sponsors and other industry partners often ask SCRS how they can better support sites. SCRS’ Site Landscape survey data show that although 55% of sites attempt to negotiate their withholding amount for every study, only 11% are successful. SCRS has consistently fought for better site payment terms, such as monthly payments, since our inception and progress has been made. However, we are not there yet. Now is the time to release holdback funds so that sites can continue their work to save lives. You can read the full press release here.
SCRS will continue to monitor the situation closely and respond appropriately. Thank you for the important and life-saving work each of you do on a daily basis. Now, more than ever, is the time to be proud of your profession!
COVID-19 Global Cases Live Mapping
First shared publicly on January 22 by Johns Hopkins University, the following map was developed to “provide researchers, public health authorities, and the general public with a user-friendly tool to track the [COVID-19] outbreak as it unfolds.”
Interactive Map, click red dots for statistics and drag to see different areas of the world.
Source: Johns Hopkins Center for Systems Science and Engineering. Data sources include the World Health Organization, U.S. Centers for Disease Control and Prevention, European Center for Disease Prevention and Control, and National Health Commission of the People’s Republic of China, as well as local authorities, medical sources, and news reports.
COVID-19 Trial Status Tracker
Developed by Trial Insights, this dashboard outlines COVID-19 clinical trials including their status, and related number of supporting sponsors, investigators and drug targets.
Source: Trial Insight on Scientist.com. Created by Incite Advisors, Inc. – RC – 1.0.16 TRIALINSIGHTS
Click here for their sources.
2020 European Summit and COVID-19 Plan
The safety of all Summit attendees and our commitment to put on an engaging and educational conference is of the utmost importance to SCRS.
In light of growing concerns around COVID-19, SCRS made the difficult decision to postpone our European Site Solutions Summit, originally scheduled to be held 9-10 March in Lisbon, Portugal. The European Site Solutions Summit will now be held 15-17 November 2020 at the same venue and location. Visit the website for more information.
SCRS COVID-19 Site Preparedness Survey Results
The emergence of the novel Coronavirus/COVID-19 has been a true test of the Society for Clinical Research Sites’ (SCRS’) mission: to unify the voice of the global clinical research site community for greater site sustainability. On March 12th, SCRS released a survey to better understand the challenges sites are facing, their level of preparation to navigate the current global reality and site needs related to the COVID-19 pandemic. It is important that SCRS continue to be the leader in advocating for site needs and educating the clinical research industry regarding how to navigate and address the challenges our industry is facing.