compliance in clinical trials: microsampling is a solution
by Emerson Dameron | 2 min read
Lack of participant compliance and adherence in clinical trials is a major difficulty of running clinical trials and producing the results that drive forward healthcare.
Participation in clinical trials is almost always purely voluntary. Sometimes a trial is incentivized, whereby "volunteers" receive some form of payment for their participation. In those cases, volunteers may be more compliant with trial requirements, and more likely to stick around until the trial is completed. However, the dropout rate remains high, and participant withdrawal from clinical trials carries no penalty. Some participants leave early due to unavoidable obstacles, while others elect to leave for reasons related to the trial itself.
Forte Research conducted a study to determine why participant compliance and retention is a real problem for clinical trials. The study determined that an average of 30% of all participants drop out of trials before the study is concluded. Some principal reasons given for withdrawing were:
- Inconvenient location
- Fear and anxiety
- Side effects
- Misunderstood expectations
Burden of Participation in Clinical Trials
Specimen sampling is a critical component of many clinical trials, and often the researchers need study participants to provide blood samples, as well as urine samples and other bio-fluids.
Standard venipuncture for blood sampling demands that participants travel to a central location at predefined intervals to get their blood drawn. 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 take time away from work or school, and spend time in transit to the trial site, plus time at the lab to have the specimen drawn. For a participant with a 60-minute commute (or longer) to the testing site, the sampling process, onsite consultation with trial staff, and round-trip travel might use up half a day for each visit.
Few people look forward to a venous blood draw, no matter how important it may be. For many people, the fear they feel about getting poked in the arm for a blood draw can exacerbate their anxiety and frustration, and this often leads to dropouts.
How Microsampling Improves Participant Compliance
Blood microsampling is quite different from conventional venipuncture blood collection. For one thing, it requires only one or two droplets, as little as 10µl of blood. This volume is approximately 1/1000th the size of a standard sample of wet blood in a tube, and for microsampling it is drawn with a quick finger-stick to the fingertip.
Recently developed biometric techniques and analytic devices are sophisticated enough to evaluate samples of even such tiny volumes. Therefore, it should be fairly easy for a clinical trial to transition from traditional blood sampling to microsampling.
With minimal training, the samples can be self-collected at the participant’s home or other location. This remote approach to specimen collection enables virtual clinical trials. Each remotely collected sample can be directly mailed under ambient conditions to the testing lab at the proper intervals. Participants in virtual clinical trials can forego the frequent trips to the trial site or lab, and instead collect their samples at home, package them up in the pre-stamped envelope, and drop them in the nearest local mailbox.
Specimens collected remotely through microsampling can generate reliable bioanalytical results. Offering a convenient, remote specimen collection option can be a positive solution to overcoming the burdens and fears that clinical trial participants and trial coordinators face. When you remove the commonly reported obstacles of travel, time, anxiety and frustration, you are more likely to find trial volunteers who can comply with the requirements and stick with the study until the end.
Implementation of will induce better participant retention, save money, and provide better results.