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Friday, April 30, 2010

And the Clinical Researcher winners are...

Last Fall I wrote about the Inaugural US Clinical Researcher Competition offered by PharmaTimes and sponsored by several notable pharmaceutical companies and CROs.  The competition is a peer reviewed challenge to recognize excellent performance in clinical research.  They are specifically filtering for the ideal mix of core clinical expertise and interpersonal communication skills that are vital for successful collaboration in clinical trials.

There were categories for CRAs, Project Managers, and Study Coordinators.  Challengers were nominated to participate by their colleagues.  The first phase of the competition was a 40 item online questionnaire that focused on ICH/GCP.  Successful candidates were then invited to write a role-specific essay which was anonymized and reviewed by a panel of judges. The judges narrowed their selections in March to five to eight finalists across America for each category.  The finalists traveled to Philadelphia yesterday for the final presentation to the judges and the subsequent awards ceremony.

Congratulations to all the finalists and a special thanks to all of the sponsors, supporters, and the PharmaTimes competition organizers.  Please follow these links to learn more about the candidates and the winners.  In particular, the bronze award winner in the New CRA/Site Manager category seems especially familiar to me:

Category Winners:

Category Finalists:

Thursday, April 8, 2010

Lead CRA Q&A: Dealing with Poor Performance Feedback

Anonymous said..

I understand the productivity loss, time, costs, etc of choosing an inadequate site; however, what are the ramifications against a CRA who chooses a site that turns into a "dud" site? -APRIL 7, 2010 2:00 PM

NadiaBoBadia responds...

Wow, this is a challenging question.  I only choose great sites that end up as top enrollers and execute the protocol flawlessly so I am completely unqualified to answer - ha!  In all seriousness, I think that in any job or task where you can demonstrate that you performed methodically, deliberately, and intelligently the study team would be hard pressed to fault you in your efforts.  If you build a strong reputation for yourself through quality work and your team trusts you, the backlash from these types of issues will likely be minimized but you still may find yourself "on the hook" for a poor performing site.  During my site selection efforts I keep a log of my activities and communications so I can reflect back on the process 1) to look for potential efficiencies for next time 2) to serve as a training tool for Junior CRAs that I mentor and 3) to demonstrate/remind myself/others that I was diligent and thorough in my original efforts (my colleagues and I lovingly refer to this type of documentation trail as CYA).

If I am called to task on poor performance, I will have some documentation to defend my actions, explain my thinking at the time (hindsight is 20/20), and deflect some of the backlash.  This is a delicate line because you want to explain the history behind errors but you need to be careful not to dwell and beat yourself up too much.  You have to move forward and get recruitment back on track - be proactive and start brainstorming solutions.  Just like we tell our study sites, you acknowledge the issue, you create a plan to avoid the issue in the future (obtain guidance and re-training as appropriate), and you implement that revised process.  So you picked a "dud" site, coach them, encourage them, and try to salvage things if at all possible.  How cool would it be if you worked hard enough and your problem site transformed into a model site?  If all else fails, the study team may elect to close the site and focus efforts into better performers but I hope you have been tracking your site correspondence and have been a good site manager and partner (and can prove it with documentation).

Only an unreasonable employer expects you to perform perfectly at all times.  The best we can train for is to develop a toolkit of monitoring skills and a clin ops intuition for making the best decisions.  At the end of the day, we are human and fallible and need to be able to accept our failures when they do happen (and they will happen, this can be a challenging job).  That said, someone does sometimes need to take a fall and as a CRA you may be grilled or disciplined by the study team.  You may receive poor performance feedback at a review or have an uncomfortable conversation with your supervisor or study team.  In my career,  I have known CRAs who were yanked off of trials or "sacrificed" for political reasons not necessarily performance reasons.  I've witnessed CRAs be unfairly scrutinized or singled out in meeting/telecons for site performance issues that were more or less out of their control.

Having your work or ideas criticized can be humbling and may not be warranted, but it is bound to happen at some point.  I hope for every CRA that negative feedback is always delivered respectfully and constructively.  When your work does not meet your employer's expectations, limit the excuses, graciously accept that feedback, and improve. A mistake can be devastating or it can be a development opportunity.  In other words, you can't undo errors, but you absolutely have complete control over how you react and recover from a mistake.  I keep track of my successes at work in an email folder called 'Praise'.  For example, if I get a note from a peer or a higher up complimenting my work, I file it away for later.  Reviewing the items in the 'Praise' folder is a great pick-me-up when I've had a challenging day or even to share with my supervisor when we are reflecting back on my overall performance at review time.  I've veered a bit off topic but I hope my thoughts on dealing with poor performance feedback are helpful and have addressed your question.

Reader questions may have been edited for spelling or grammar, for reasons of anonymity, truncated, or edited in other ways although the main content remains unchanged.

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Saturday, April 3, 2010

Selecting Qualified Investigators

The focus of this post will be selecting adequately performing US clinical trial sites for Investigational New Drug studies.  Depending on the nature and size of your clinical trial, you may be targeting private practices, specialists, academic centers, purpose-built dedicated clinical research facilities, or a combination of any of these to find your principal investigator(s) (PI).  Certainly, there is great cost associated with opening and maintaining a study site so you are well advised to be thorough and thoughtful when evaluating the potential investigators.  As monitors, we may provide input on the clinical operations of a study and assist or manage projections of how many and what types of PIs will be selected and this article will discuss some of the important considerations for qualifying and selecting study sites.
As qualified CRAs, we use our instincts and training to predict and choose the most qualified and motivated PIs.
Inevitably, some study centers will perform better than others and deliver the ideal study candidate while strictly adhering to the protocol.  Careful site selection is absolutely critical to limit the time and resources that will be required during study conduct to manage poor performing sites; I refer to my non-enrolling or poor performing study centers as “duds”. Duds require additional monitoring oversight, coaching, and avoidable cost for continued participation, therefore, these sites are often closed before enrollment or conduct is complete.  Closing a non-performing site is an attractive option to suspend the siphoning of time and resources, but forethought and a well-coordinated site selection exercise can help ensure dud sites are never opened in the first place.
Consider the therapeutic area of study and recruit PIs with relevant experience, the right study tools and equipment, access to the target subject population, interest/motivation to recruit, and availability to participate.  

You needn’t only consider PIs with prior clinical trial experience, but you may gain some considerable efficiencies by targeting PIs who have performed well in prior studies and audits.  Some PIs pay to be listed in clinical trial directories, you may be able to obtain names of doctors to approach through online physician directories, reviewing PIs you or your colleagues have worked with in the past, internal company databases, conference attendee lists, patient advocacy groups, journal article author searches, pharmaceutical sales personnel, medical association websites, telephone directories, the internet, trade journals, other networking contacts, etc.

The FDA maintains lists of disqualified investigators and those that are prohibited or restricted to conduct clinical trials.  You can also review any previous warning letters or license restrictions using publically available databases (Click on the hyperlinked text and see additional links below for further information).  Your investigators will need to adhere to all ICH/GCP guidelines and relevant CFR sections including 21 CFR 312.53.  Check your potential PIs against these lists and also gather anecdotal information regarding the investigator from colleagues and the internet. Read physician review websites like or clinician directories.  Determine if there have been previous inspections at the study center.  Some doctors have their own websites and you can also search news databases to find information about a potential PI you are considering.

Finally, you can contact the physician and his staff to inform them of the trial, determine their interest, and request that they fill out questionnaires or provide a copy of their CV or a summary of their experience.  If you do develop site selection questionnaires you can ask them for their input on the trial design, to describe their facility, to quantify their qualifications/experience/availability/resources/staff, to identify if they have the proper equipment, to comment on their previous clinical trial or audit experience, to give details on their IRB process, to project potential recruitment and access to the target subject population (double check that there aren’t competing trials at the facility or within the same geography, to detail translation and advertising needs, and to inform you of any anticipated barriers to recruitment.  Much of this work can be done via telephone/fax/email but you may want to schedule a time to visit their office and evaluate whether they are a fit for your trial. For more information read my post on Pre-Study Visits.

Beyond the questionnaire, you can use the site selection process to gauge the communication style, organization, and responsiveness of the site staff.  
Beyond the questionnaire, you can use the site selection process to gauge the communication style, organization, and responsiveness of the site staff.  Ensure there are no conflicts of interest, lack of objectivity, or other reasons to avoid a specific PI.  You will be able to determine the PIs experience conducting other sponsored trials, develop a feel for the turnover at the site, and sniff out any additional red flags that may steer you away from choosing that site or anticipate issues that might creep up during conduct.  Be tactful, gracious, and considerate of their time.  The PI will be evaluating whether they want to work with you as well.  It is very much a two-way street since you may be working closely together for a considerable amount of time if they do join the trial.

Good luck selecting qualified investigators. Definitely take the time before the trial starts to be thorough and deliberate with the site selection process.  There is always pressure to get sites up and running as quickly as possible, but you must balance that need with the requirement to spend adequate time selecting qualified investigators. Hopefully spending enough time choosing your PIs will ensure your trials will be easier to enroll, your studies will be conducted with less protocol deviations, and your study team will be more likely to avoid unnecessarily costly “dud” sites and achieve all of your study objectives.

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