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Clinical Trial Injuries
Clinical trial agreements can almost always be negotiated. Most part-time investigators, however, do not have the necessary legal expertise or time to interpret the agreement and conduct an effective negotiation. Proper legal representation at present requires an attorney who is expert in this very specialized field. Because sponsor negotiators often have huge backlogs of contracts in process, and over half of part-time investigators do not negotiate (or even read) the clinical trial agreement, an investigator who opens a negotiation may never emerge from the queue.
A New System
A new system to help negotiators is now in the works. Over 200 sites, sponsors, contract research organizations (CROs), and site management organizations (SMOs) have joined together in MAGI, the Model Agreement Group Initiative. MAGI is developing a very flexible “multiple-choice” model clinical trial agreement to streamline negotiations in the U.S. and internationally. MAGI's growing membership includes representatives from over two-thirds of U.S. News & World Report's Top-50 Research Medical Schools and Honor Roll hospitals, many of the largest SMOs, the four largest CROs (eight of the top nine), two of the top four biotechs, and a number of smaller and mid-sized pharmaceutical companies.
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