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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Linda Kaplan who wrote (4479)	6/6/1998 7:27:00 AM
From: biodoc	Read Replies (1) \| Respond to of 7041

It is not unusual for the scenario to go like this: Pharmaceutical company designs trial (with help from consultants) and selects an investigator to "run" the trial. He runs trial, data is sent to pharma company on crf' (or a contractor of the company). Trial is analyzed by company and report is sent to investigator. It can have various levels of detail, but in some cases it can be less than complete. Often the company writes and prepares the slides for the presentation. Often the investigator doesn't see the total analysis. An ethical sponsor would not put the investigator in the position of not knowing of any warts in the trial, but there is great opportunity here for spin. The fact he ran the trial doesn't mean he is aware of all the details of what really happened. I do not know Dr. Goldstein, but do know that there are various levels of involvement in the actual trials by investigators. Some are involved in many trials--but the more you do the less time you can devote to an individual trial. In my opinion, a satisfactory presentation includes: Trial design, to include treatment arms, randomization scheme, blinding method, patient population (to include the precise inclusion and exclusion criteria), definition of primary endpoint and method of analysis of primary endpoint. Presentation of the characteristics of who actually got in, by treatment group. Details of exposure to drug. Drop out and loss to follow-up rates. Reasons for treatment discontinuation. Safety analysis: adverse events, serious adverse events, related advese events, deaths, any events which resulted in discontinuation of drug. Analysis of primary endpoint including details of statistical methods. Discussion of any secondary endpoints.