Design of a national counseling skills program for clinical trial staff

Abstract

Nonadherence by trial participants to the study drug regimen threatens the satisfactory conduct of the best designed clinical trial. Reduced adherence confounds the interpretation of the study's results and may leave the study's primary question unanswered. Recent reports from multicenter clinical trials have reported adherence rates of 60%–90%. This presentation examines the use of a drug marker in counseling to improve participant adherence to a medication regimen. Potential benefits and problems are identified, and several recomendations are offered.Increasingly, behavioral counseling has been used by clinic staff members to improve the medication adherence of trial participants. Behavioral counseling is a databased counseling process emphasizing patient collaboration with the clinician in idenfying, diagnosing, and intervening in medication adherence problems. A valid, accurate drug marker would have direct application in both identifying and intervening on a medication adherence problem. However, a marker would not contribute substantially to the clinician's ability to diagnose accurately the nature of the medication aherence problem.A major concern is the manner in which the clinician introduces the drug marker into the counseling process. The use of data from a drug marker can have a strong positive or negative effect on the medication adherence problem. It also can significantly influence the continuing relationship between the clinician and the participant. Examples are presented.It is strongly recommended that the clinician identify the specific goals for the marker's use prior to the introduction of data from a medical marker into the participant counseling process. Further, the manner in which the marker is introduced into the interview with the participant must be considered carefully. It is recommended that special training be required of clinical staff for the use of data from drug markers for both monitoring and counseling for medication adherence.