Study Subjects Currently Enrolled in a Clinical Research Trial
Conditions
Keywords
text messaging, safety, real time data
Brief summary
Study RTD-01 is a non-interventional, pilot study designed to determine if a specific coded SMS text message study tool is effective in collecting daily real time safety data in subjects participating in clinical trials.
Detailed description
This study is to determine if a daily SMS text message study tool will improve adverse event and concomitant medication reporting. Patient reported adverse events and changes in concomitant medications are essential in clinical trials to determine drug-related symptoms and side effects. This study will help identify the benefits and challenges of real time daily reported outcome measures that can later be implemented in future clinical trials to enhance trial outcomes. In addition, data collected from this study will support a more sophisticated safety study tool for future study participants.
Interventions
None listed
Sponsors
HDC
Perseverance Research Center, LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Inclusion criteria
* 18-85 age inclusive * Male or Female * Currently enrolled in an ongoing clinical trial * Capable of providing informed consent and complying with daily study procedures * Must be able to receive and respond to text messages through phone provider
Exclusion criteria
* Subjects not currently involved in a clinical trial * Subjects who cannot receive text messages * Unable to comply to the study protocol and study visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To improve AE and concomitant medication reporting | 6 weeks | Data collected daily through secure text messaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease recall bias | 6 weeks | Daily reporting of AEs and concomitant medication changes |
Countries
United States
Outcome results
None listed