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 on the following dates to read the blogs in this 5-part series!
Difficulties with obtaining clean data during post-progression studies
Post-progression studies are defined as visits or contact following completion of treatment, surgery, radiotherapy, or chemotherapy. They are usually an extension or sister study of an original trial. Often post-progression studies involve the same questionnaire from the main study. During this time, patients usually stop taking the medication or begin taking an alternative medication. Not all studies have a post-progression element, but follow-up studies often become more common when early mortality decreases and more patients are available for follow-up.
In the event that a patient is close to relapse, they begin taking many drugs which makes it difficult for sponsors to obtain clean data, but regulators are pushing for it. Post progression studies can be challenging due to the fact that visits are more likely to be remote and patients can take any medication during this phase. They also come with the same challenges as the original trial. Sites have heavy administrative tasks and patient-centricity is lost.
Remote data collection for reduced burden on post-progression subjects
With regulators driving sponsors to include post-progression/follow-up periods in their oncology trials, eCOA solutions can help reduce the burden on patients by remotely collecting data as site visits become less frequent. The key to keeping compliance high in this phase of the study is to deploy a flexible solution. The many different modalities within eCOA can help to provide this, with sponsors having the ability to choose from a range of solutions to meet their data needs. Options sponsors can deploy include:
- Patients complete questionnaires at home using a provisioned device. The device can remind patients when to report and guide them through collecting data at home.
- Patients complete questionnaires at home using a web diary. A flexible solution allows patients to report on a range of devices.
- Patients complete questionnaires at home using an app. The app allows patients to use their own device and they can be reminded when to report via an SMS message.
- Patients come to the site to complete their questionnaires. If they can’t make it to the site, a clinician can transcribe their responses on a tablet device at the site. This tasks the sites with ensuring data is collected from the patient.
The most appropriate method will depend on the needs of the study, but sponsors have many options to collect data without increasing patient burden when using eCOA.
Improve post-progression studies with eCOA
Contact us to learn more about how you can improve your post-progression studies with eCOA.
About the Author
Jackie Brusch is the Content Marketing Manager at CRF Health.More Content by Jackie Brusch