Pharmaceutical new product development: why do clinical trials fail?

A high percentage of new drug candidates fail to reach the market during clinical trials, and these failures imply massive financial losses for the pharmaceutical companies. Clinical trials have distinctive characteristics and additional complexity compared with the late stages of product development in many other industrial sectors. Although the current literature on clinical trial has offered explanations for why a drug is abandoned during clinical trials (e.g., toxicity, lack of efficacy, and economics), studies investigating non‐drug‐related causes of failure are scarce. New product development (NPD) failures also differ from one another; however, no comprehensive conceptual framework in the NPD literature describes how to classify failures. This study suggests a conceptual framework for explaining NPD failures in the pharmaceutical industry by drawing on clinical trial literature combined with an exploratory empirical approach based on 17 interviews with industry experts. The initial interviews were used to identify managerial issues related to clinical trial failure, and the later interviews had a more iterative character to validate the issues identified in the previous round. We identified seven critical management issues causing failures in clinical trials. Our findings indicate that chaotic and slow patient recruitment, lack of experience in choosing and monitoring partners, lack of feasibility of the study protocol, low quality of the registered data, too high incidence of serious adverse events and severe incidents, unmanageable level of portfolio complexity, and incorrect assessment of the market potential or returns cause the failure of clinical trials. The conceptual framework for failures proposed in this paper combines project and product failures while acknowledging relevant specificities in clinical trials. Clinical trial managers are also supported in their decision making in clinical trials with an identified list of critical management issues that require attention to reducing the chance of failure. This study provides a basis for future empirical testing, including measuring interdependencies among the critical management issues and their adequacy for predicting failure.     

Financial Accounting Effects of Tax Aggressiveness: Contracting and Measurement

This study examines a setting in which a tax‐reporting decision is delegated to a firm's tax manager. Using financial accounting measures of tax expense to evaluate the tax manager allows the firm to efficiently attain the level of tax avoidance it prefers, despite the fact that the consequences of the tax‐reporting decision will occur in the future. The study also examines how well two accounting measures of tax aggressiveness — cash taxes paid and the unrecognized tax benefit — distinguish between conservative and aggressive firms.     

Kapitalisierung von Paarbeziehungen

This study examines the role that the social networking site Facebook plays in the different aspects of relationship management by couples. The communication of couples is influenced not only by the relationship phase but also by the geographical distance between the partners. Based on the assumption that these factors are also important for the couple’s (partly) public Facebook communications, the online survey explores whether couples in the first phase of a relationship or in a long-distance relationship use Facebook intensively for relationship management. Furthermore, the concept of capitalization (Gable et al. (2004, 2006)) is applied to the social network communication. Originally, it referred to interpersonal communication. In conjunction with the publicity of social networks, the awareness of others could change the processes of capitalization. It can be shown that relationship management in a narrow (“romantic”) sense is upheld on a rather low level. Contrary to expectations, there is less (partly) public relationship communication in the first phase of a couple’s relationship as well as in long-distance relationships. Also contrary to a culturally pessimistic point of view, Facebook is not replacing traditional forms of relationship communication. Capitalization also has deficits; nonverbal forms of communication such as facial expressions, body language, and gestures are lacking on Facebook, despite all of its various emoticons.