Guest Commentary: TWO NEW CLINICAL TRIAL DATABASES RAISE THE BAR ON TRANSPARENCY

Pharmacy Times, Volume 0, 0

In this time of ever-increasing scrutinyand skeptism concerning the pharmaceuticalindustry, it is absolutelyimperative that we in the industry continueto look for opportunities to raisethe bar, when it comes to providingtransparency to patients, customers,and critics. At Eli Lilly and Co, we seeour mission as providing answers thatmatter—answers that allow patientsand their health care providers to makethe most informed decisions possibleabout the medicines they take.

As a company, Lilly has gone onrecord as being committed to medicalresearch principles that define the ethicalconduct, funding, and communicationof clinical research. Lilly madeits commitment to these principleseven more prominent in December2004, when it launched a clinical-trials-registryWeb site www.lillytrials.com.

Regardless of outcome, Lilly hascommitted to publicly disclose theresults of all trials of marketed products,past and present, for which Lilly isthe sponsor. This disclosure includesthe results of all phase 1 (earlyexploratory), phase 2 (proof of concept),phase 3 (registration), and phase4 (postmarketing) trials conductedanywhere in the world. For productsand indications approved and marketedbetween July 1, 1994, and July 1,2004, the registry will be populatedwith core safety and efficacy registrationstudies. We also will assign anindependent third party to audit andverify our adherence to these standardsfor disclosure.

We have taken deliberate steps totruly simplify complex medical terminologyby providing a glossary for thelayperson. The ability to "word search"the Lilly registry offers visitors a quickway to search for specific matters ofinterest or concern. We also have provideduseful external links to resourcesthat can simplify and enhance a visitor'ssearch for medical information.

In addition, lillytrials.com goes onestep further. It uses the site to notifythe public when we begin a clinical trialthat will later be included in theapplication submitted to the FDA forapproval, or when we will conduct apostmarketing study that will exploreusing the drug for another disorder.

Lilly also recognizes the progress theindustry as a whole is making to becomemore transparent. We have played anactive role in developing and supportingthe industry-wide result database, createdby the Pharmaceutical Research andManufacturers of America. Clinical-StudyResults.org is a publicly accessibledatabase site that serves as an on-lineclearinghouse of sorts to enable themedical community to find comprehensivescientific information about prescriptionmedicines.

Our hope is that a publicly availableclinical-trial registry, which providesresults from all industry-sponsoredclinical trials of marketed products,will prove useful for all persons seekinginformation on a broad range of illnesses—from serious and potentiallylife-threatening diseases to chronic anddebilitating conditions, includingdepression, osteoporosis, and diabetes.

Finally, we know that you, America'spharmacists, play a vital role inthe health care decision-makingprocess. Patients rely on a pharmacistto be their trusted advisor—someonewho provides important counselingand answers to their questions aboutmedications.

We encourage you to visit andfamiliarize yourself with these 2 newWeb sites so that you can take advantageof all the information available toyou. Ultimately, providing qualityhealth care to patients is what mattersmost, and we appreciate all you do tomake it a reality.

Mr. McShea is part of the Trade AccountManagement team at Eli Lilly and Co anda member of the Pharmacy Times Boardof Advisors.