Raise Your Voice — Letters

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Site Value I think most agree the PI/coordinator/patient relationship is key to enrollment and most importantly retention. Therefore PROs should be viewed in the context of their value added to each site that agrees to participate in a study as opposed to being viewed as an added value to the study as insurance against pre-established sponsor timelines. — Dan Ulrey, Midwest Clinical Support Inc. March 2007 Delivering Value on Patient Recruitment With respect to your article on patient recruitment in February’s issue, “Patient Recruitment Marketing,” I believe sponsors are not getting the return on investment on their expenditures from patient recruitment organizations (PROs) for a few reasons not mentioned. It has been my experience that many PROs fail to deliver added value because of the sponsors’ internal processes, organizational structures, and timing of events. For example, the processes of identification and selection of sites are done far in advance of having completed protocols and site budgets, and are done by study project teams that are usually not responsible for screening and selecting patient recruitment organizations. The timely release of completed protocols and site budgets needs to occur well in advance of the selection of sites so the physician investigators/sites can do their due diligence as to their populations and/or their estimates as to profitability of a study since most sites are for-profit operations. If that were the case the value or nonvalue of a PRO could be better determined. As CEO and founder of a multitherapeutic network of 391 independent sites throughout the United States for the past 10 years, I believe it’s in the best interest of sponsors to assist sites in any way possible to be successful before site initiation. Sites should be prepared to rapidly enroll and retain within the timelines from date of receipt of drug. While I agree there is a shortage of patients in many clinical indications, there is a “critical” shortage of experienced profitable, GCP-compliant, U.S.-based investigators and study coordinators. I think most agree the physician investigator/coordinator/patient relationship is key to patient enrollment and most importantly retention. Therefore PROs should be viewed in the context of their added value to each site that agrees to participate in a study as opposed to being viewed as a value add to the study as insurance against pre-established sponsor timelines. PROs working with each site in advance of initiation to develop an individualized plan that each site agrees to would be a big step in the formation of proactive partnerships and possibly could be a criteria for the selection of the PRO as an alternative source. I believe the time has passed when clinical R&D was viewed and organized primarily as a cost of doing business instead of more appropriately as the key asset on a sponsor’s balance sheet — an asset that is 100% controlled by the success or failure of independent sites to enroll and retain patients and deliver data. Sites and patients should be viewed as partners and not commodities with respect to clinical studies. In conclusion, I suggest we bury the term “trials” once and for all and call them what they are from the viewpoint of a prospective patient — studies. Not being a judge or a prosecutor I try to avoid participating in any kind of trial. I think most prospective patients would also agree. Keep up the good work. Daniel M. Ulrey President and CEO Midwest Clinical Support Inc. Prediction for Personalized Medicine As our industry develops more targeted therapies through pharmacogenomics, healthcare public relations will play a pivotal role in educating the public about personalized medicine. (See “The Age of Personalized Medicine,” February 2007 issue of PharmaVOICE.) The lay attitude is crucial to successful implementation of personalized medicine, which has the potential to deliver significantly more effective diagnosis, therapeutics, and patient care. Clients will rely on public-relations programs to arm consumers with the facts about pharmacogenomics research, science, and ethical issues, through comprehensive and balanced media coverage and customized educational initiatives. Ilyssa Levins President HCIL Consulting Pardon us … In the February 2007 issue of PharmaVOICE, we inadvertently provided an inaccurate company description of Model N Inc. in the article “Looking Ahead: The Deficit Reduction Act.” Model N, which is based in Redwood Shores, Calif., is a provider of revenue management solutions. To learn more about the company, please visit modeln.com. PharmaVOICE apologizes for the error and any confusion it may have caused.

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