How Studies Are Classified During COVID-19 Outbreak
Tier 1 Studies
These studies have a high possibility of improving the health of the research participants. They include:
- All clinical research studies involving COVID-19 treatment in which there is a strong possibility of benefit for a patient’s survival OR
- When alternative treatments are severely limited AND
- When there is a possibility of serious or immediate harm for someone if they do not participate in the study.
- Clinical research studies that include treatments for urgent life-threatening health conditions (such as some cancer treatment trials).
- Clinical research studies where stopping the treatment (like some investigational drugs, vaccines or drug treatments for disease prevention) might harm the participant.
Tier 2 Studies
These studies have a fair possibility of improving the health of the research participants over time. If they were not available, these studies might pose a long-term risk to the participant. For example:
- Clinical research studies testing treatments for chronic conditions (for example asthma, high blood pressure, depression, diabetes, HIV, fatty liver disease, etc.)
- Clinical research studies testing the safety or effectiveness of a treatment that if stopped, would significantly impact the potential benefit to society and advancing science. Example: collecting a blood sample is only valuable if it is collected at a very specific time.
- These types of studies must be measured against the risks of COVID-19 exposure to our research participants and staff.
In-person enrollments in Tier 2 studies were temporarily stopped as of March 23. Study teams have been asked to convert as many in-person study activities to virtual or remote visits as possible.
If you are in a Tier 2 study and have questions about upcoming in-person visits, please contact your study team. Some Tier 2 studies may continue to enroll people using remote technology.
Tier 3 Studies
These studies do not offer the possibility of directly improving the health of the participants OR the risks of exposure to COVID-19 are too high to allow in-person contact. These studies include:
- In-person surveys
- Focus groups
- Other types of observational studies
Each research unit is deciding which of their research studies meet these tiers. Any studies that do not meet the Tier 1 level have paused active in-person enrollment and visits until further notice. Tier 2 studies stopped active, in-person enrollment but may make use of remote technologies for enrollment and visits.
Frequently Asked Questions
Which clinical research studies will be affected?
Studies that involve in-person contact with participants but have no possibility of improving their health are paused until further notice. We've encouraged all of our study teams to change in-person study visits to video conference visits or phone calls when possible.
Which research studies will not be paused?
Studies that meet the criteria for Tier 1 or Tier 2 as described above. In effect, studies that have the possibility of providing a direct health benefit to the participant are not paused. In-person enrollment and treatment continue for Tier 1 studies. In-person enrollment and visits for Tier 2 studies are temporarily paused but may switch to remote technologies when possible and appropriate.
Will I still be able to enroll in a clinical trial?
Enrollment in Tier 3 studies was placed on hold on March 23. Tier 2 studies that do not have remote enrollment options are temporarily paused until further notice.
Tier 1 continues to enroll new participants ONLY if there are no other treatments available AND there is the possibility of improving the health of the participant. Clinical trials with placebos (harmless medicine that does not treat or cure) are on hold.
If you are being screened or have recently consented to join a clinical trial, please contact the study team to learn the tier of your study.
I live far away – should I travel to Duke to participate in a Tier 1 research study?
We understand that sometimes Duke may offer a study that may not be offered at a site close to your home. Deciding to risk traveling to Duke for that study is a personal decision that you should make with your local health care provider. You should balance the risks of travel with the possible benefits of participation in the research study.
In addition, please note Duke's updated visitor restrictions.
If someone needs to travel with you to Duke so you may participate in an in-patient clinical trial, please keep in mind that they may not be allowed to enter the hospital with you. All visitors will be screened alongside patients before they are allowed entry to the outpatient clinics or hospitals.
Who should I contact to learn if my study is paused?
All study teams are contacting people currently enrolled in a study or scheduled to enroll in the near future. However, you may contact the study team using the phone number on your consent form to determine if you should come in for your next study visit.
If you are in Tier 1 or Tier 2 study and are scheduled for an in-person visit during this crisis, the study team may contact you ahead of your visit to ask if you have symptoms of COVID-19. If you are not screened ahead of your visit, you will be screened when you arrive for your visit.
What should I do if I am in treatment on a clinical trial?
If you are in treatment on a clinical trial (for example, getting a study drug), you may continue treatment, although your study visit schedule may change. When you come for your treatment, please be prepared to answer questions about your recent contacts, travel, and health. This screening is intended to protect you, your family, and our healthcare workers.
If you are sick, have symptoms, or have been exposed to somebody who has COVID-19, your visit may be rescheduled. We will do everything we can to maintain your treatment schedule.
What should I do if my next visit is a follow-up visit?
Follow-up visits are not treatment visits. A member of the study team will contact you to discuss these visits before your next scheduled visit. We may reschedule or cancel these visits or convert them to video or phone visits.
Please contact your study team with any questions or concerns. We are here to help guide you.
If you are having side effects or have been diagnosed with COVID-19, please contact your study team right away using the 24-hour contact number in your consent form.
If you do not have or cannot access your consent form, please call the myRESEARCHpartner's line (919-681-5698) and we will help you find the person you should talk to.
What should I expect if I come to Duke for a study treatment?
Call the day before your visit to answer the screening questions:
- Have you or your family members traveled in the last 14 days?
- Do you or anyone in your home have any of the following symptoms: cough, fever, shortness of breath?
- Have you or anyone in your family had any contact with a confirmed COVID-19 patient?
If you answer yes to any of these questions, we may delay your visit for at least 14 days. You should also talk to your healthcare provider.
When you arrive for your treatment you will be asked these questions again.
Can I participate in my study remotely?
You may be asked to participate in your study by talking with the study team by phone or through video conferencing using a computer or mobile device. Contact your study team to find out if this is an option.