Trial DriftThe Revolution and the Evolution ofClinical Blended Learning™

DATA MANAGEMENT AND TECHNOLOGY FORUM ❘ 91

A clinical blended learning

approach minimizes trial drift

and adds value to all parties

involved in a clinical trials

project, and thus minimizes

the day-to-day challenges

and issues associated with

trial drift.

Stage 1: Looking Back

As we look back at the coined introduc-tion of the “trial drift” phenomenon inan article first published in The Monitor’sWinter 2004 edition, we find this defini-tion: “Trial drift occurs when the averageinterest level and knowledge base amongclinical trial personnel deteriorate dur-ing the course of the trial. In otherwords, the longer the trial continues, themore it drifts, unless proper interventionoccurs.” (See Figure 1.)

Increasing awareness and under-standing of this phenomenon havehelped many organizations embrace theconcept and begin looking for solutionsto minimize issues related to the every-day management of clinical trials.

Stage 2: The Revolution

The introduction of electronic systemshas always presented our industry withthe opportunity to develop better waysto manage clinical trials. The initialparadigm as the technology revolutionbegan was to develop technologies thatgave the end users a final electronicsolution that would force them tochange. However, the introduction ofnew technologies has always come at the expense of painful learningcurves for sponsors, contractors, andinvestigative sites. From the late 1990sto the early 2000s, tremendous tran-sitional efforts by industry leaders were confronted with strong resistance

DATA MANAGEMENTAND TECHNOLOGY FORUM

Al O. Pacino II

FO

RU

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by the end users, and the speed of changeeventually slowed almost to a halt.

As technology solutions improvedtheir business models, more and moreorganizations began to embrace the con-cept of combating trial drift with suitableand more conservative technology solu-tions during their clinical trial planningstages. To quote again from the earlierMonitor article (and see Figure 2):

Obviously, proper trial planning is keyto trial success. Planning can beimproved by including experts withcurrent and updated knowledge in aspecific therapeutic area, up to date intraining and communications technol-ogy and with current knowledge of pro-ductive investigative sites. This isespecially important because a sitedeemed efficient several years ago mayno longer be considered efficient giventoday’s standards, mostly due to theinability or a laggard attitude for tech-nology adaptation. Patients are becom-ing more educated and tend to migratetowards the best and latest therapies.Such experts often have better informa-tion on state-of-the-art technologydesigned to streamline clinical researchprocesses and minimize trial drift—andchoosing the proper platform is essential.

Over the years we have learnedthat an appropriate training and com-munications strategy is a must to thesuccess of any clinical trial. As ineffi-ciencies increase, training should beincreased to head off knowledge drift.The inability to assess and benchmark

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clinical trial timeline drift. Plannedstudy goals can change due to the shiftin attention paid to clean ups and firedrills, which can make it difficult tocollect and manage data properly. Theinappropriate and inefficient use oftechnology vehicles for staff educationand assessment, especially at the inves-tigative site level, can lead to staff frus-tration and decreased interest in thestudy. Improper training and commu-nications planning can damage thestaff ’s knowledge base and enthusi-asm, and erode managerial control.

Therefore we must identify the bene-fits of Clinical Blended Learning™ to allparties involved.

Regulatory Benefits

As regulatory agencies increase scrutinybefore, during, and after the clinical trialproject, more and more competencydocumentation is required. Having acentralized, trial-specific platform forelectronic documentation can minimizeskepticism by regulatory agencies, be-cause documentation can be accessed atany time before, during, and after theclinical trial project.

We all know from experience that awell-documented clinical trial can mini-mize issues associated with regulatorycompliance in many areas of study. Con-versely, identifying and documentingknowledge-base deficiencies before theinvestigator meetings, then complement-ing such documentation with investigatormeeting group and individual focus, canprove to regulatory agencies that the clini-cal trial has been well planned and wellorganized. Furthermore, immediate andreal-time intervention and documentationof trial drift can be continuously achievedas the clinical trial project progresses.

Study Manager, Sponsor,and CRO Benefits

As sponsors demand faster information,intervention, and results at a lower cost,study managers must stay up-to-datewith their challenging schedules. Screen-ing personnel, identifying weaknesses,and focusing their education on ensur-ing that personnel invited to the investi-

92 ❘ MONITOR OCTOBER 2007

Figure 1. Trial Drift

Note: Low interest at (–3) months, increasing at investigator meeting (0). Drifting interest and knowledge base throughout the duration of the clinical trial.

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Trial Duration (in months)

–3 0 3 6 9 12 15 18 21 24

Figure 2. Trial Drift Intervention

Note: Low interest at (–3) months, increasing at investigator meeting (0). High interest and knowledge base maintained throughout the duration of the clinical trial.

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Trial Duration (in months)

–3 0 3 6 9 12 15 18 21 24

knowledge drift in a clinical trial canprofoundly affect trial management,and in some cases, can delay commu-nications, thus the ability to addressthe problem quickly.

Stage 3: The Evolution of ClinicalBlended Learning™

Painfully, the old paradigm for develop-ing technologies that make end userschange (referred to above) has evolved.Over the past few years, technologydevelopments have increasingly beeninfluenced by end users and investigativesite staff members involved in clinicaltrials, and decreasingly influenced by ITand software developers.

Technology is molded to the need ofthe end user as the need arises, which hasled to a slower, but more acceptable,transition to user-friendly technologies

within our industry, and thus to em-bracing the concept of Clinical BlendedLearning™ for educational purposes.Clinical Blended Learning™ is a logical,simple, reasonable, and convenient com-promise between the standard approachto education taken in project initiationmeetings and the introduction of onlinetechnology solutions (see Figure 3).

Benefits to Interested Parties

As readers learned in the earlier Monitorarticle:

Trial drift in one area of a study canproduce a chain reaction that can bedifficult to control. Poor inter-raterreliability in patient recruiting mayresult in poor recruiting skills, whichin turn may limit patient pools and a

gator meeting understand what is ex-pected in the project timelines can makethe sponsor, the study managers, and theCRO’s jobs much easier.

Investigator Site Staff and End User Benefits

Just as sponsors demand a faster approachto the everyday management of their clin-

ical trial, physicians and their staff mustalso balance their schedules and prioritizetheir projects as investigative sites and endusers look to streamline their efficiencies.The empowerment of end users allows forownership and a higher value to theirproject involvement at the local level. Theability to access educational informationon a 24/7, on-demand basis, along withthe ability to document local competency

levels, takes most of the pressure off allparties involved. The ability to accesseducational documentation on demandat the investigative site, management, anddecision-maker levels adds to the lineageof historical competency and up-to-daterecordkeeping that is essential in ourindustry.

Conclusion

A blended approach to clinical trials andresearch projects can become a goodmarriage and a great bridge betweentechnology and the more conventionaleducational approach. This approach isincreasingly being embraced in manyphases of our industry as we construc-tively find ways and solutions to combatthe trial drift phenomenon.

Al O. Pacino II is a senior executive with more than18 years’ experience in the healthcare and clinicalresearch industry. He is the founder and presidentof TrainingCampus.com, the platform for theInternational Electronic Education Network™,and vice-chair of education for the ACRP DataManagement and Technology Forum. He can bereached at (512) 302-3113.

Figure 3. Trial Drift—Clinical Blended LearningTM

Note: Screening (–3) months, focused intervention at investigator meeting (0). High interest and knowledge base maintained throughout the duration of the clinical trial.

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Trial Duration (in months)

–3 0 3 6 9 12 15

Legend: A: Screening personnel to participate in the project. B: Identifying competency through specialized trial specific assessments. C: Group focused learning at investigator meeting based on “B”. D: Individual focused learning at investigator meeting based on “B”. I: Proper trial drift intervention during the project timeline.

UK REGIONAL CONFERENCE2007

www.acrpnet.org/ukregionalconference

Institute of Directors116 Pall MallLondon, SW1Y 5ED United Kingdom

Practical Aspects of Clinical Research in the UK

11 October 2007

Topics include:

Acquiring the Skills to Face Intelligently the Challenges in Day to Day Clinical Research

Working with Combination of Drugs/Devices

Interview Skills in Specific Clinical Research Situations

How do we Work with the Paediatric Regulations

Improving Subject Recruitment