Farida Dabouz holds a PhD in Statistics with a broad industry experience as well as academic international oncology group in Europe and Canada. In addition to her many accomplishments in Biostatistics/Data Management at Sanofi and BCIRG, she also leverages her experience in “data quality” on applying innovative approaches in the field of biostatistics, data management and medical writing to improve data processing. She has a strong experience in training site investigators and operational teams, covering all data aspects, mainly demystifying statistics in clinical trials. She is Certified/Active Member of SOCRA and SCDM education committee, providing webinars and online courses.

Clinical trials are conducted on all new medicines and devices. Regulators will only approve a new medicine or device if these trials, together with other research data, demonstrate it has a favorable risk: benefit profile. Historically, the majority of patients recruited into clinical trials for medicine development have been from Western Europe and the US. However, clinical trials are increasingly recruiting patients from other countries, including developing countries. Also, the landscape for clinical trials has continued to evolve and change over the last twenty years. Clinical trials have become more complicated but not more efficient. The increased complexity of today’s clinical trials is associated with reduced patient enrollment and retention, higher risk for protocol amendments, and longer and more costly clinical trials. Clinical trials are used to assess the benefits and harms of interventions in health care, and if conducted properly, the risk of bias is minimized, particularly bias in selection of patient populations, endpoints and analysis. There is, however, considerable evidence that clinical trials are not always well reported. The usefulness of a Clinical Study Report (CSR) depends on the clarity with which it details the relevance of its, participants, outcomes, and design to the real world practice. ICH E3 is guidance on how to present the results in order to provide a level of details that will enable a secondary evaluation i.e. an assessment by regulatory authorities of the conducted analysis and conclusions drawn. ICH E9 is guidance on the content of the Statistical Analysis Plan (SAP) and presents recommendations for information to be included in key sections of CSR. A well written and complete research protocol is essential for a high quality study and avoids problems during the study. Clear and unambiguous SAP minimizes the risk of bias in the analysis and provides detailed statistical methodology used as well as the definition of Tables, Figures and Listings (TFLs) to be included in the CSR. Clear, complete and concise CSR streamlines regulatory review, publishing and facilitate the use of study results in real word. 

Maria Lindau, a Licensed Psychologist and PhD, is an Associate Professor at the Dept. of Psychology, Stockholm University, Sweden. She has about 20 publications, and 15 years of experience as Neuropsychologist and is a Researcher at Memory Clinics at Karolinska and Uppsala University Hospitals. She has Bachelor of Arts in History, French and Political Science

Neuropsychological assessment is time-consuming, and examination of healthy individuals with the ten core Wechsler Adult Intelligence scale, Fourth Ed., (WAIS-IV) subtests to assess Full- Scale IQ (FSIQ) may well exceed 90 minutes. Clinical testing of patients must be presumed to take even more than 90 minutes, and additional time is required for the fi ve optional subtests in the battery. In order to reduce testing time a considerable amount of studies have been produced to identifythe most statistically reliable abbreviation of the WAIS. One of the most commonly used short forms (SF) of WAIS-IV is the sevensubtest short form of the WAIS-IV, originally developed by Ward (1990). Th is SF includes the following subtests: Block Design (BD), Similarities (SI), Digit Span (DS), Arithmetic (AR), Information (IN), Coding (CD) and Picture Completion (PC).

According to Meyers et al., 2013, this SF has good psychometric qualities. Of importance is that the subtests included in this SF are selection of tests whose validity and reliability are based on norms from an American sample. However, the prevailing view is that neuropsychological tests must take cultural diff erences into consideration, with respect to the content of the testing tasks as well as the norms used to estimate the performance levels. Therefore, the aim was to validate the seven-subtest SF on a Swedish non-clinical sample. In order to see if the time consumption was possible to lower even more, the aim was also to explore a further reduction of the number of WAIS-IV subtests. Th e study sample consisted of 138 subjects (74f/64m) ranging from 19 to 90 in age. Data from the seven subtests was analyzed with linear regression. Th e results indicated that the sevensubtest model predicted 93.5% of IQ, p<.0005, and a four-subtest model consisting one test from each index: CD, SI, BD and AR predicted 88.3% of IQ, p<.0005, which means that the FSIQ prediction accuracy for both models was extremely high. SFs are particularly helpful in the investigation of psychiatric and geriatric patients. When an understanding of the patient’s functioning across cognitive domains administration of a complete WAIS may be to recommend.