Recruitment is a crucial part of the Clinical Study workload. Even if no clinical trial is actively searching for subjects, recruitment is an ongoing process in order to build a database of potential participants.
Because of ethical standards within the industry, it can be difficult to actively recruit a large number of participants in a short period of time. Any advertisement or initiative with the goal of recruiting participants which will be seen by the public must be approved by an Institutional Review Board (IRB). Because of this, the key to recruitment is planning and communication.
Potential participants are currently sheltering in place and looking for ways to earn money while most workplaces are shut down. On the other hand, some participants are hesitant to participate in clinical trials; they have many concerns about issues such as public transportation and social distancing measures within the clinic space.
The best way to reassure these participants is to plan based on Ontario’s guidelines for workplaces and to communicate this clearly. For example, social distancing measures must be used whenever possible and each subject should answer a short questionnaire to determine their risk of having COVID-19. In addition, all participant needs must be considered when it comes to in-clinic visits; some participants have expressed that they would prefer to be contacted for trials only after the pandemic concerns die down.
Here are some strategies to follow to reassure participants that the CRO is safely operational:
Non-essential staff should continue to work from home.
Although Ontario is moving into stage two in many regions, it is still best practice to work from home whenever possible, particularly when considering workplaces with a lot of interchangeable visitors such as a CRO clinic space.
Include Ontario’s Guidance Questions in your telephone pre-screening process
In order for participants to be narrowed down they need to be pre-screened, usually using a questionnaire based on the trial inclusion and exclusion requirements. The government of Ontario has released questions to help citizens decide whether or not they should go to work, and consequently whether they should go to a testing centre.
Measure participant’s temperature upon entry.
One of the first signs of illness is fever. Participants and, whenever possible, CRO staff, should have their temperatures measured with an infrared, touchless thermometer to determine that they are healthy and not putting anyone else in the clinic or waiting area at risk. The staff member taking temperatures will be trained in confidentiality practices in order to safeguard patient and staff privacy.
Encourage participants to avoid public transportation.
Any area where subjects may come into close contact with a large population of strangers should be avoided, particularly considering that surfaces can retain the virus causing the pandemic for extended periods of time if not properly cleaned. If participants MUST use public transportation, they should be encouraged to wear gloves and other personal protective equipment, such as masks, if possible.
Provide sanitizer and personal protective equipment upon entry.
Frequent handwashing is highly recommended by the CDC and has been since the beginning of the spread of the pandemic. Once a participant has confirmed that they do not have any troublesome symptoms or fever, they will be provided with hand sanitizer, masks, gloves, and any other personal protective equipment that staff or Investigators deem necessary to decrease contact with surfaces, staff, and other participants.
Social distancing measures should be used in the workplace.
All participants should be seated six feet apart in any waiting area and unless safety and blood tests are being taken, the same measures will be taken with CRO staff. If staff are within close contact with participants, both parties should wear face masks as an added precaution.
All surfaces should be cleaned in between participants.
In order to limit subject-subject contact and the spread of germs, all surfaces in the clinic should be cleaned before and after any tests are taken.
dicentra’s CRO team has been working hard over the past several months to implement these policies. We’ve also been communicating with our participants constantly over telephone and email to reassure them that we are doing everything we can to keep staff and subjects safe.