15 Dec The Future of Clinical Trials is Now
Triage Cancer believes that everyone should have access to quality cancer care. Sometimes, that care comes in the form of a clinical trial. We have a number of resources on clinical trials, but wanted to share with you a newer resource from one of our partners, that might be helpful for you.
One of the earliest clinical trials can be dated as far back as the famous 1747 scurvy study conducted by James Lind. Almost 200 years later, in 1946, the first randomized controlled trial occurred on streptomycin, an antibiotic we continue to use today. Over time, technology has advanced but many aspects of running a clinical trial have remained the same, until now.
Science 37 has introduced a new model and approach to running clinical trials by combining technology with telemedicine. Participants in a Science 37 clinical trial can join, receive study medications, and participate from the comfort of their home, no matter where the study is being conducted. The goal is to allow participants to join clinical research from home, and reduce the pain of travel or the inability to participate due a patient’s geographic location. For current cancer research opportunities that are being conducted in this way, please visit https://www.science37.com/participants.
Here are some potential scenarios to illustrate the differences between a Science 37 clinical trial and a traditional clinical trial:
Science 37 Clinical Trial Traditional Clinical Trial
|1. Initial Search & Signing Up|
Jane is newly diagnosed and searches the internet to learn more about her condition. She lands on a virtual trial site.
Jane is newly diagnosed and searches the internet to learn more about her condition. She lands on an academic site's research study page. The trial site is a 72 mile round trip from Jane’s home.
|2. Being Contacted|
Jane signs up online to receive more information. A study coordinator reaches out to her the following day.
Jane calls the site & is scheduled for a screening clinic visit.
|3. Getting Screened|
Jane is screened by phone to determine eligibility. She answers questions about her condition.
Jane drives to the clinic site, checks in and waits to see the study staff who screen her to determine eligibility. She answers questions about her condition.
|4. Giving Consent|
Upon confirming eligibility, Jane is given access to a secure website portal where she can review electronic informed consent documents. She takes time to review them while at home and discusses them with her family. She later contacts the research coordinator to complete the virtual informed consent process via phone & video teleconference. The study coordinator and investigator ensure that she understands the study & is willing to volunteer. Jane was able to schedule her virtual consent process around her busy work schedule.
Upon confirming eligibility, Jane is given the informed consent documents to review. She decides to take them home so that she has more time to read them and discuss them with her family. She later makes a follow-up visit to return to the clinic where she undergoes the informed consent process. A study coordinator and investigator ensure that she understands the study & is willing to volunteer. Jane had to take time off from work to return to the clinic to complete the informed consent process.
|5. Participation and Follow-Up Visits|
Jane completes the study baseline procedures at home. These include getting vitals signs and blood work by a mobile nurse. Study medications are shipped to her home and her study questionnaires are completed through the NORA app on the study iPhone.
Jane receives a new shipment of study medications every month to her home and completes monthly study questionnaires on NORA.
Jane returns to the research clinic to complete the study baseline procedures. These include getting vitals signs and blood work by the clinic staff. She completes a paper questionnaire and is given her one month supply of study medication to take home. She is scheduled to return to the clinic every month to get a refill of study medications and to complete the study questionnaires. She has to check with her work to make sure she will be able to take time off for the next study visits.
|6. Reporting Side Effects|
Jane wants to report noticing a new rash so she calls her study coordinator using NORA on her study iPhone. She is advised to take a photo of the rash through NORA. The study investigator is notified and within a few hours, Jane is given instructions on how to manage the rash.
Jane wants to report noticing a new rash so she calls her study coordinator in the clinic. She describes the rash over the phone to the study coordinator who states that they will need to contact the investigator and call Jane back. After speaking to the investigator, the study coordinator calls Jane and instructs her to return to the research clinic the next day for evaluation. Jane is concerned and must ask her boss to take more time off from work to go to the clinic.
|6. Study End|
Jane is contacted by the study coordinator to give her instructions about completing the study. She completes some questionnaires on NORA, and ships back the remaining study medications and study iPhone. Jane joins a community of others who share her condition so that she can receive updates on the study and learn about future trials.
Jane takes a day off from work so that she can return to the research clinic for her last visit. She is accustomed to the routine of driving to the clinic, checking in at reception, and waiting to be evaluated by the research staff. During the visit, she complete some questionnaires and returns the remaining study medications to the staff.
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