{'fraction_non_alphanumeric': 0.02510460251046025, 'fraction_numerical': 0.005379557680812911, 'mean_word_length': 5.3893129770992365, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
The role of interim analysis as a quality assurance function in practice-based research network clinical studies.

In this issue of the Compendium , the authors present “Postoperative Hypersensitivity in Class I Resin-Bonded Composite Restorations in General Practice: Interim Results.” This clinical study is being conducted by the dental practice-based research network (PBRN) termed Practitioners Engaged in Applied Research and Learning (PEARL) Network, which is a partnership encompassing the National Institute of Dental and Craniofacial Research (NIDCR) as the funding source, The EMMES Corporation as the data coordinating center, and New York University College of Dentistry as the administrative core. 1 The PBRN concept challenges the traditional paradigm of clinical studies. The Vioxx® (Merck & Co., Inc., Whitehouse Station, NJ) issue, which caused Merck to withdraw the drug in 2004, raised many concerns regarding safety for a recently approved drug. The number of patients in the Phase III pivotal studies totaled more than 8000, yet the full impact of Vioxx on cardiovascular health had been found insignificant. The issues that emerged once the drug was on the market initiated a complete review of the Food and Drug Administration’s (FDA) drug safety program, leading to consideration of alternatives for conducting clinical studies. One such pathway involves research performed by clinicians in their offices in an effort to broaden the clinical population and to be more inclusive of various health conditions to better expose potential drug safety issues. The traditional drug development paradigm is sequential, consisting of animal studies, Phase I