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

Author: Michael E. McShea, RPh

In this time of ever-increasing scrutiny and skeptism concerning the pharmaceutical industry, it is absolutely imperative that we in the industry continue to look for opportunities to raise the bar, when it comes to providing transparency to patients, customers, and critics. At Eli Lilly and Co, we see our mission as providing answers that matter—answers that allow patients and their health care providers to make the most informed decisions possible about the medicines they take.

As a company, Lilly has gone on record as being committed to medical research principles that define the ethical conduct, funding, and communication of clinical research. Lilly made its commitment to these principles even more prominent in December 2004, when it launched a clinical-trials-registry Web site www.lillytrials.com.

Regardless of outcome, Lilly has committed to publicly disclose the results of all trials of marketed products, past and present, for which Lilly is the sponsor. This disclosure includes the results of all phase 1 (early exploratory), phase 2 (proof of concept), phase 3 (registration), and phase 4 (postmarketing) trials conducted anywhere in the world. For products and indications approved and marketed between July 1, 1994, and July 1, 2004, the registry will be populated with core safety and efficacy registration studies. We also will assign an independent third party to audit and verify our adherence to these standards for disclosure.

We have taken deliberate steps to truly simplify complex medical terminology by providing a glossary for the layperson. The ability to "word search" the Lilly registry offers visitors a quick way to search for specific matters of interest or concern. We also have provided useful external links to resources that can simplify and enhance a visitor's search for medical information.

In addition, lillytrials.com goes one step further. It uses the site to notify the public when we begin a clinical trial that will later be included in the application submitted to the FDA for approval, or when we will conduct a postmarketing study that will explore using the drug for another disorder.

Lilly also recognizes the progress the industry as a whole is making to become more transparent. We have played an active role in developing and supporting the industry-wide result database, created by the Pharmaceutical Research and Manufacturers of America. Clinical- StudyResults.org is a publicly accessible database site that serves as an on-line clearinghouse of sorts to enable the medical community to find comprehensive scientific information about prescription medicines.

Our hope is that a publicly available clinical-trial registry, which provides results from all industry-sponsored clinical trials of marketed products, will prove useful for all persons seeking information on a broad range of illnesses—from serious and potentially life-threatening diseases to chronic and debilitating conditions, including depression, osteoporosis, and diabetes.

Finally, we know that you, America's pharmacists, play a vital role in the health care decision-making process. Patients rely on a pharmacist to be their trusted advisor—someone who provides important counseling and answers to their questions about medications.

We encourage you to visit and familiarize yourself with these 2 new Web sites so that you can take advantage of all the information available to you. Ultimately, providing quality health care to patients is what matters most, and we appreciate all you do to make it a reality.

Mr. McShea is part of the Trade Account Management team at Eli Lilly and Co and a member of the Pharmacy Times Board of Advisors.