compliance in clinical trials: we can do better
by Emerson Dameron, on Jun 1, 2017 6:16:00 AM
Lack of participant compliance in clinical trials is one of the chief difficulties of running clinical trials and producing the results that drive forward healthcare.
Participation in clinical trials is in almost all cases purely voluntary. Patient withdrawal in clinical trials carries no penalty. Some participants leave for unavoidable causes while others elect to leave for reasons related to the trial.
Forte Research conducted a study to determine why retention is a real problem for clinical trials. The study determined that an average of 30 percent of all participants drop out of trials before they conclude. Some principal reasons given for withdrawing were:
- Inconvenient location
- Fear and anxiety
- Side effects
- Misunderstood expectations
Burden of Participation
Blood sampling is a critical component of many clinical trials.
Standard venipuncture sampling demands that participants travel to a central location at predefined intervals. This blood sampling must be performed in a controlled environment where the sample can be drawn and immediately analyzed or refrigerated. The process of drawing a standard blood sample requires that the individual spend time in transit plus several minutes at the lab to have the specimen drawn. For a participant with a 30-minute commute to the testing site, the sampling process and round trip travel might use up at least 90 minutes for each visit.
Few people look forward to venous blood extraction, no matter how painless the process happens to be - that fear and anxiety can exacerbate the frustration that leads to dropouts.
How Microsampling Can Improve Participant Compliance
Blood microsampling requires only a single droplet, as little as 10µl of blood. This volume is approximately 1/1000th the size of a standard sample and is drawn with a quick finger prick.
Recently developed biometric techniques and analytic devices are sophisticated enough to evaluate samples of even such tiny volumes.
With minimal training, the samples can be self-drawn at the participant’s location through virtual clinical trials, and can be directly mailed under ambient conditions to the testing lab at the proper intervals.
Generating bioanalytical results from specimens collected through microsampling can be a positive solution to overcome the inconveniences that clinical trial participants and faciliators face. Implementation will induce better participant retention, save money, and provide better results.