Guidance on Clinical Trial Conduct
Coronavirus Treatment Acceleration Program (CTAP)
FDA Urges Clinical Researchers to go Virtual in Response to COVID-19 Pandemic
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic:
Guidance for Industry, Investigators, and Institutional Review Boards
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
Considerations to Support Clinical Trial Monitoring Oversight During COVID-19
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.
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.
Statement from the President
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 Summit will now be held 15-17 November 2020 at the same venue and location.
With recent travel restrictions related to COVID-19 from several sponsor, CRO, site and solution provider organizations, we believe it was in the best interest of all attendees to postpone the Summit. In addition to your safety, our ability and commitment to put on an engaging and educational conference for all attendees is of utmost importance. For those who were attending the conference, we understand there are logistical inconveniences that accompany this decision, and we apologize for the disruption. SCRS endeavors to make this change as easy for you to manage as possible. All current registrations will automatically transfer to the new dates unless another arrangement is made. Further information can be found on the European Summit website.
The spread of COVID-19 and the related disruptions to our personal and professional lives shines a light on 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 we have a solution in place that enables us to continue successfully conducting studies. With the recent news of COVID-19 and its expected impact on our lives including travel restrictions, quarantines and more, sites must be prepared to conduct decentralized clinical trials (DCTs).
The COVID-19 situation has shed light on why clinical research is so important. The site community plays a crucial role in discovering cures and vaccines that ultimately save and enhance lives. SCRS celebrates clinical research sites and other industry players as we work on trials to create medicines to protect and vaccinate against COVID-19 and other viruses and diseases.
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, 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.
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.
Sponsored by VirTrial
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.
Of those who participated in the survey 84% are from site organizations, 8% are from sponsor or CRO organizations and 8% are from professional solution providers. Of the site respondents, 39% are part of a site network.
One of the major concerns that unprecedented events such as the COVID-19 pandemic raises is the impact on clinical trial enrollment and retention, as well as the safety and well-being of currently enrolled patients. A vast majority of sites – 58% – anticipate that COVID-19 will negatively affect their enrollment. This is supported by respondents’ view of patient retention and the challenges government restrictions place on keeping patients enrolled in studies. Nearly half of respondents (47%) feel COVID-19 will have a negative effect on retention, and 37% of respondents were still unsure of the impact on retention. This indicates a strong need for providing support to sites that will enable and enhance patient retention as well as help them identify innovative solutions that extend beyond current trial models.
At the time of the survey, most sites were confident that this issue would not adversely affect the safety of their patients as it relates to the trial. With 36% reporting it might or might not impact patient safety and 36% reporting it probably or definitely will not, sites are confident that they will be able to monitor and maintain the safe and ethical treatment of their patients to the best of their ability
Most sites are beginning to see changes to trial conduct, particularly regarding the incorporation of decentralized/remote/virtual measures or activities. 49% of respondents reported an increase in the incorporation of plans to integrate remote elements into trials to ensure the trial continues with minimal impact. With recent guidance from the Federal Drug Administration (FDA) to go virtual in response to the COVID-19 pandemic, the emphasis on being prepared to conduct study visits and activities virtually has increased and it is important that sites begin preparing for this immediately. SCRS is happy to report that 42% of sites indicated they are prepared to implement virtual elements into their trials. An equal number, however are still discussing this possibility and navigating the incorporation of virtual elements like remote study visits.
SCRS has created a pathway for sites to prepare to incorporate virtual elements into their trials by providing access to a Virtual Trial Capable Training program at no cost, in partnership with Global Impact Partner (GIP) VirTrial. The series of modules take less than 20 minutes to complete and lay the foundation for sites to participate in decentralized clinical trials (DCTs). With a majority of survey respondents indicating they have not taken this training, SCRS is calling for sites to immediately prioritize taking the Virtual Trial Capable Training. Doing so will increase the global site community’s preparation for the eventuality of virtual elements being incorporated into clinical trials.