Clinical trials medical adviser

Three randomized clinical trials support the efficacy of bupropion in ADHD. The first used doses up to 6 mg/kg (98) the other two used doses of 100 to 300 mg per day in equally divided daily doses spaced at least 6 hours apart ( 99, 100). The concern with bupropion is its seizure risk, which requires that its daily dose stay below 450 mg per day in adults (i.e., approximately 6.5 mg/kg). Virtually no work has been done to determine the plasma concentrations of bupropion and its three active metabolites in children and adolescents. Hence, it is unknown whether a limit of 6.5 mg per kg is also appropriate for children. No data exist as to whether children are more or less sensitive to bupropion in terms of seizure risk at the same drug concentration. Also, little is known about pharmacokinetic drug-drug interactions that could reduce the clearance of bupropion. For these reasons, cautious dosing is advised when prescribing bupropion for children on other medications that can reduce oxidative drug metabolism (see Chapter 3 and Chapter 7 for more details). 

In some cases, it may be prudent to obtain a certified copy for the subject s clinical trial file. For example, if the records are not owned by the investigator or under his or her control, such as patient medical records held by the hospital, depending on the hospital s archiving procedures it would be advisable to obtain certified copies for the clinical trial file in case the hospital loses, misplaces, or intentionally destroys the documents under an established record retention schedule. This is all part of CQA s oversight role regarding the appropriate transfer and authentication of raw data and source documents. 

On March 2, 2004, the Canadian Medical Association Journal reported on a 1998 internal GSK document that had been leaked to it (Kondro et al., 2004). The memorandum advised staff at the international drug giant GlaxoSmithKline (GSK) to withhold clinical trial finds in 1998 that indicated the antidepressant paroxetine... had no beneficial effect in treating adolescents. ... 

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