Why early clinical trial conditioning might just be the change you need!

Kirk Nielson, SVP, Managing Director, Iris Global Clinical Trial Solutions

Is anyone else growing tired of the constant “buzz” about the challenges surrounding today’s drug development and commercialization environment? On any given day we are reminded that these are difficult times, that new drug applications are down, R&D costs up, and drug approvals are continuing at a slow pace. This is further accentuated by the reality that competition for patients in trials for many of today’s promising new compounds (in opportunity-rich therapeutic areas) is at an all-time high, and increasing regulatory demands have significantly affected the complexity of global clinical research initiatives.

“As an initial step toward achieving market-leading success, it is critical that we begin to view our current challenges with a forward-focused lens and create the solutions that address the future rather than just the barriers”

We all understand that we are not conducting business as usual, that strategic innovation is paramount, and that market-leading success depends as much upon our preparation for each stage of clinical research as it does on the intelligent (albeit aggressive) manner in which we move downstream along the commercialization continuum.

As an initial step toward achieving market-leading success, it is critical that we begin to view our current challenges with a forward-focused lens and create the solutions that address the future rather than just the barriers.

Key Insights Impacting Patient Enrollment

While the concentration on strategic innovation in the area of clinical trial enrollment is imperative, a forward-focused approach should be applied to any major trial challenges along the entire continuum. 

To help get our arms around the issues, we should start by reviewing a few prevailing insights that are currently preventing a number of clinical operation management teams from moving forward on the most successful path possible. All insights are presented in first-person (from the perspective of clinical operations) to help bring them to life:  

"I know how much time it takes to plan and run a study 'right,' but the pressure from commercialization lead is intense, so we're under orders to move forward as fast as possible."

 "I know my investigators, but I'm increasingly distanced from them: their attention is being pulled in so many directions, and they're also increasingly feeling the burden of financial operations intrude on their commitment to advancing medicine and patient care. My trial is being pushed aside by their [principal investigators'] real operational anxieties."

"My trials are getting so large-numerically and geographically-that the cost of addressing the enrollment challenges of 'bad' sites is increasing almost exponentially. It may actually be a net savings of money and time to simply acknowledge the incremental costs to date [in poorly performing sites] and accelerate the funding of new sites."

"Oncology patients have always been harder to accrue, but now we're likely to experience similar difficulties in unanticipated therapeutic areas, such as Diabetes. I know there are a large number of studies competing for the same subjects, but finding patients and getting them into our trials requires a lot more effort."

Do any of these ring true for you or your organization? It turns out that a growing number of clinical trial sponsors are citing several contributing factors to the escalating number of trials experiencing lower than expected subject enrollment rates. These include the lack of adequate early trial preparation, limited investigator relationship-building opportunities, inadequate new investigator training initiatives, and insufficient patient motivation. And while trial sponsors are working to address the issues, few have realized any real degree of success.

Innovative Early Clinical Trial Conditioning

In an attempt to embrace our new commitment to forward-focused thinking and market- leading success, we must consider the possibility that in today's early clinical trial environment there are sets of relatively untapped (and uncollected) data that may very well hold the key to unlocking many of our current challenges. The data would have to be properly collected and analyzed to render the study intelligence necessary to provide fresh perspectives to address significant change, but the opportunity to advance how we view clinical trial enrollment is within our reach. This early study intelligence includes, but is not limited to:

• A longitudinal snapshot of the competitive study landscape
• A deep assessment of the principal investigator's level of interest/engagement in the experimental drug
• A complete understanding of the availability and level of experience of new investigators and their study support staff
• An unprecedented view of patient clinical trial awareness and readiness of high-potential subjects

Once fine-tuned, this intelligence can become the input into a new and innovative Early Clinical Trial Conditioning initiative specifically designed to move into action key study targets: investigators, coordinators, subjects, caregivers, and when applicable, clinical operations teams. Conditioning in this case denotes a prolonged experience (18-24 months is typical), where respect, trust, and loyalty have sufficient time to flourish, paving the way for new mindsets, increased awareness, expanded relationships, and broadened knowledge. Unlike today's accelerated planning efforts, conditioning provides the benefits of time-thoroughly understanding the complexities of the study environment, and having firsthand knowledge of key study audiences' attitudes and behaviors. This culmination of intelligence and purpose helps position your team to take full advantage of the invaluable months leading up to a trial, to determine how best to overcome or better navigate a number of today's existing barriers. The idea of "Market Conditioning" is hardly new; brand marketing teams have been conducting upstream initiatives prior to launch for years in an attempt to better prepare a therapeutic marketplace (base of treating physicians) for the entry of a new drug. If past results are any indication, successful conditioning efforts have significantly improved the early uptake of a new drug at launch, and are equally capable of minimizing a growing number of enrollment challenges.  

Not surprisingly, Early Clinical Trial Conditioning is a strategic initiative that requires a team well versed in the essential planning, analysis, and tactical activities necessary for successful design, implementation, and ongoing program optimization. Integrated conditioning plans targeting multiple stakeholders can be customized for each study, and over time they become a best practice. Also, conditioning plans represent segmented communications that rely on insights to craft highly motivational messages and tactics to help drive study targets to action. Given the early executional nature of these activities, it is imperative that metrics be captured and analyzed, not only to help optimize the effectiveness of the conditioning initiatives, but also to begin building a robust knowledge base that can be leveraged across the trial, leading to launch, and downstream throughout the commercialization continuum of the lifecycle of a drug to drive widespread success.

Importantly, if we want to stay ahead of the competition or catch up with the leaders in this area, a significant emphasis must be placed on penetrating today's study subjects, for successful enrollment in this new, forward-focused world is all about building a mindset of clinical trial readiness in high-potential individuals. Whether subjects are driven by altruism, better disease management, improved quality of life, or a potential cure, they remain the audience with the largest communication gap, and therefore the greatest need!

Getting Your Clinical Trial Conditioning Initiative Off to a Great Start

Now that we have posed a clearer understanding of the Early Clinical Trial Conditioning concept and its benefits, it may be helpful to discuss how best to evaluate an organization's own readiness and the steps necessary for getting started. As with any new initiative, this would be the perfect time to step back and take a hard look at the organization's early clinical trial planning process and seek out answers to the following questions:

• Where are the knowledge gaps regarding the current study landscape?
• Is there a thorough understanding of the study target audiences? If not, who does?
• How are relationships built and maintained with the principal investigators being considered for the next trial?
• What percent of the principal investigators are currently involved in loyalty programs that result in the exchange of real value they can pass along to their patients, practices, and healthcare communities?
• What is the understanding of the overall patient "clinical trial" readiness level in the study's therapeutic area?
• Has a behavioral change mechanism been implemented, such as the Transtheoretical Model, to help build trial "ready" individuals? (See NGP EU, Q1 2010, Page 130, Trouble Shooter article for more insights on this model.)
• What skills are lacking to successfully develop and implement a conditioning program for an upcoming study market?

While it is certain each person responsible for clinical trial success has a general idea of their organization's strengths and weaknesses regarding many of these questions, the investment in a good change assessment process is critical to creating a sound foundation and helping to ensure that a conditioning initiative gets off to a great start.  

Real Benefits Require Real Change

The potential benefits of Clinical Trial Conditioning are undoubtedly significant, and we would like to think that it would be a relatively straightforward decision for the majority of senior management faced with delayed trials due to low enrollment. The reality is that real change, and the real forces impacting patient enrollment require commitment to ourselves and our organizations to produce a forward-focused, success-oriented communications approach. Moving upstream along the commercialization continuum and taking advantage of the benefits of Early Clinical Trial Conditioning could expose the clinical operations team, and organization for that matter, to a virtually untapped opportunity for driving improved enrollment success and accelerated new drug commercialization. Please continue doing your part to drive impactful change!         

Mr. Nielson is also featured in the NGP EU Q1 2010 print issue on page 130 with his article, "Clinical Trial Enrollment: An Untapped Opportunity-Motivate Patients Who Aren't Ready."

This article was first published in issue 9 of NGP Europe magazine: www.ngpharma.eu.com/article/Why-early-clinical-trial-conditioning-might-just-be-the-change-you-need