Many clinical trials today are still using paper to collect data. Over this 5-part blog series, we’ll examine some of the common challenges with data collection during oncology trials today and explore how you can overcome these challenges. Check back soon to read the next blog in this 5-part series!
Patient challenges with data collection during oncology trials
Cancer patients that are in a great deal of pain are often unable to attend site visits and find it difficult to report their data. This leaves sites with non-performing patients or patients that do not provide all of their health data on a regular basis, creating confusion and leaving sponsors with uncertainty around the treatment’s efficacy. Other challenges that patients experience include:
- Strenuous travel to sites, sometimes requiring long hours in a vehicle
- Failure to keep track of their numerous medications and treatments
- Inability to attend a site visit / missed site visits that require rescheduling and the subject to complete questionnaires all over again
- If patients become seriously ill, attending site visits may become too demanding, so assistance completing questionnaires and participating in the trial is necessary to avoid subject drop-out
Reducing patient burden of clinical trial data collection
In 2016, the American Society of Clinical Oncology (ASCO) reported that the U.S. Food and Drug Administration (FDA) cited the benefits in PROs could be the basis for full drug approval. And although PROs are rarely used to measure primary outcomes in an oncology trial, they are often invaluable for secondary and exploratory outcomes such as: quality of life, time to pain progression, and time to worsening of physical symptoms.
So… how does eCOA support patients?
Patient-centric focus is one of the biggest benefits eCOA solutions provide. Patients too sick to complete the questionnaire at the site are able to remain on these studies because eCOA supports:
- Rescheduling site visits to provide flexibility for patients who may not be feeling well
- Re-activating incomplete or interrupted visits so that patients can pick up where they left off
- Adding unscheduled visits for patients who may need additional time at the site due to a change in their diagnosis
- Extending data entry windows to accommodate the patient
- Implementing a caregiver role to maintain data collection without adding burden to the patient
Supporting caregivers of oncology patients with eCOA
Cancer patients that are very ill but still want to participate in clinical trials have the option to elect a caregiver role on their eCOA device. This allows the caregiver to input data on behalf of the patient, supporting them throughout their journey using Observer Reported Outcomes (ObsRO).
On-device training is provided to help caregivers feel comfortable with the process and sustains compliance by ensuring the data is reported regularly per the study protocol.
The importance of options for patients
Without these options for reduced patient burden, the likelihood of poor data quality, subject drop-outs, or site challenges greatly increases. In turn, study teams are unable to collect data or feel confident about the data that they have collected.
Solutions that reduce patient burden are much more effective, providing study teams with the highest quality, dependable data that helps find a cure for cancer, one step at a time.
Interested in learning more about how you can enable greater patient participation and compliance?