A Patient’s Journey through the Clinical Trial Processby Applied Informatics
The number one concern for all investigators involved in clinical trials is the recruitment process. Why is it a headache you ask? Even after making the initial connection with the participant, replying to the referral message from the participant that shows their interest in the clinical trial, it is difficult to maintain a communication pipeline between the two parties.
Let’s go through a quick overview of the whole process…
First, the patient must fill out a contact referral form to become a potential study participant. Then, participants of a clinical trial undergo a thorough screening process to ensure they meet the required criteria for participation. This screening process can take around 3-4 weeks to complete, and usually involves a series of questions related to your health, the medications you take, and possibly your lifestyle. During these 3-4 weeks, the researchers must determine if the participant is the right person for the study. On the other side of the coin, the participant must also determine if the study is right for them.
Through this whole ordeal, the connection is lost between the participant and investigator far too often. This archaic process relies on a huge database and too many avenues to sort out communication between the two parties. With all these variables, no wonder it is inevitable the ball gets dropped.
So, how can we make this a smooth process?
Our follow up module keeps track of the entire participant-investigator connection from initial referral to recruitment. All of this is seamlessly integrated within the iConnect system, which is an all-in-one, patient-friendly clinical trial recruitment application.
The follow up module keeps track of the process by dividing it into three states.
- Pre-Connection -> Participant has sent a referral, but there is no connection with the investigator.
- Pre-Screening -> Participant and investigator have been connected and a screening has been scheduled.
- Pre-Recruitment -> Participant has been screened and is now waiting to see if they are qualified.
The Pre-Connection state occurs after the participant has sent the referral. Every few days, i.e. a pre-determined period, an email is sent out to the participant and investigator asking the respective party if the other has reached out. If the investigator or both (investigator and participant) says “Yes, I was contacted”, then this can be moved forwarded to the next state.
The Pre-Screening state is similar to the previous state, where an email is sent out to the investigator and participant every period asking if they have been scheduled for a visit to be screened. Once, the investigator or both (investigator and participant) have stated that a visit has been scheduled for the participant, then the participant’s status is now at Pre-Recruitment.
The Pre-Recruitment state occurs only once the participant has been scheduled for a visit to be screened. In this phase, an email will be sent out every 7 days to the investigator and participant. If the investigator declares the patient eligible and enrolls him for the trial, then the participant is good to go for the trial. SUCCESS!
This entire process will be overseen by the central contact of the respective Clinical Research Organization.
This is how the new follow up module of iConnect will ensure no participant is lost in the world of clinical trial recruitment. It’s easy to see that IConnect and Follow Up – A Patient’s Journey, is a marriage made in heaven.
For more information on iConnect, please click here.