Investigator Initiated Studies – Industry or Investigator – “Who Wins?"

How everybody wins when playing by the rules: the benefits of investigator-initiated industry-sponsored clinical trials.

2007;28:262– 66 34. Kollia K, Maderwald S, Putzki N, et al. First clinical study on ultra-high-field MR imaging in patients with multiple sclerosis: comparison of 1.5T and 7T. AJNR Am J Neuroradiol 2009;30:699 –702 35. Gilbertson JR, Miller GM, Goldman MS, et al. Spinal dural arteriovenous fistulas: MR and myelographic findings. AJNR Am J Neuroradiol 1995;16:2049–57 36. Ferrer I, Kaste M, Kalim...

Lipid Core Cost for Investigator-Initiated Services

Institution/investigator-initiated clinical trials in Canada.

Institution/investigator-initiated clinical trials in Canada require adherence to similar regulations and processes required of large pharmaceutical manufacturers. This may require an investigator to file a Clinical Trial Application. This article outlines the responsibilities and actions that are required prior to, during, and after the conduct of an institution/investigator initiated trial.

Industry, academia, investigator: managing the relationships.

Financial self-interests in medical research are again the subject of increasing public and government concern. Proposed new statutes and regulations would prescribe research conduct and oversight, as well as faculty behavior, in ways that would represent an unprecedented interposition of federal authority into areas of traditional university autonomy. Overly zealous regulation could also inter...

Quality and completeness of data documentation in an investigator-initiated trial versus an industry-sponsored trial.

Literature on the quality and completeness of data and documentation in investigator-initiated research studies is scarce. We carried out a study to compare the quality of data and documentation in an investigator-initiated trial (IIT) with those in an industry-sponsored study. We retrospectively studied the archived data pertaining to 42 patients enrolled in two trials, 14 patients in an indus...