Recruiting productive and experienced clinical trial investigators is a critical component of the drug development process. In fact, as sponsors face growing pressure from contracting study timelines, increasingly "experienced" patient populations, and competition for top-performing investigators, the value and importance of the investigator to the sponsor will only continue to grow.
That being said, sponsors could greatly benefit from a better understanding of what drives investigator satisfaction and an intimate understanding of the pressing issues these individuals face.
One vital component of an investigator's experience and ultimate success or failure on a clinical trial is the central laboratory, according to the Life Science Strategy Group's (LSSG) recent report, "Clinical Trial Investigator Satisfaction and Central Laboratory Performance." The report cites that as sponsors strive to pull more information out of each clinical trial, and push development into emerging markets with new logistical challenges, the role of the central laboratory will continue to grow.
Therefore, investigator interaction with and preferences for central labs are important elements sponsors can use to ensure investigator satisfaction, solidify important relationships, and ultimately maximize clinical trial ROI.
Of the 552 investigators around the globe who responded to LSSG's October 2011 online survey, 87% agreed that they are most satisfied and willing to work with a sponsor on future trials when they have selected their preferred central laboratory from past clinical trials. In addition, 97% of investigators stated that the central laboratory selected by the sponsor impacts their overall success as a clinical investigator.
These findings clearly demonstrate that the choice of a central lab can greatly affect a principal investigator's satisfaction level while conducting a clinical trial. Overall, this translates into willingness to perform future work with a sponsor, making it easier for that sponsor to reach their enrollment targets.
In addition to highlighting primary drivers of investigator satisfaction, the recent LSSG study also unveiled particular labs that sponsors most prefer to work with and why. Covance was proud to be the central lab ranked best to work with by investigators, with 54% citing Covance as the Central Lab they most preferred to work with, followed by the next closest lab at 18%.
Some leading factors contributing to a strong relationship between a central lab and an investigator included 1) fast, easy access to the lab/POC 2) strong communication/customer service 3) high-quality lab results 4) easy-to-use lab kits and 5) overall lab reliability.The survey also uncovered some other key issues when it comes to investigator satisfaction. Of the principal investigators surveyed, 84% said they were "very willing" to participate in more clinical trials. Their reasons included knowledge gained from a clinical trial, better care for patients, and access to new medications.
The complexity of designing and running clinical trials can be challenging and expectations are continuously increasing. Without question, the quality and productivity of the clinical investigator plays a pivotal role in trial execution as it impacts so many success factors: patient recruitment, adherence to protocol, data quality, etc. While the CRO is responsible for the recruitment of skilled and experienced investigators, the importance of the central laboratory in influencing investigator participation cannot be underestimated.
Also, keep in mind that while the central laboratory function may consume 10% of a typical clinical trial budget, it can responsible for the delivery of up to 90% of the data submission package. This further emphasizes the importance of a sponsor's central laboratory selection.
To learn more about the study, or to download sample Pages from the report, visit www.lifesciencestrategy.com.
The "Clinical Trial Investigator Satisfaction and Central Laboratory Performance" survey, conducted in October 2011, by the Life Science Strategy Group, questioned physicians actively participating in pharmaceutical industry-sponsored clinical trials as investigators. Participants were prescreened to ensure a high level of involvement and/or key decision-making authority for their investigative site. All global geographies and practice settings were represented, as were more than 20 medical specialties. The mean experience level in a clinical trial setting was 13.4 years.