Featured Articles

51. Not Just Tiny Humans: Considerations For Conducting Pediatric Clinical Trials 4/28/2017

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. While we can’t predict the outcome, planning ahead for appropriate site conducting clinical studies in pediatric patient populationsand subject selection will take you one step closer. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

52. What To Know About Clinical Research With Vulnerable, Cognitively Impaired Patients 9/7/2016

    As researchers, we need to consider how we simultaneously protect patients who are cognitively impaired or may become cognitively impaired during a study with the need to include this population as part of our research. Unlike children, pregnant women, and prisoners, the current Code of Federal Regulations for the Protection of Human Subjects (45 CFR Part 46) does not contain specific guidance for the protection of subjects with cognitive impairment in clinical trials.

53. 7 Tips To Recruit And Engage Clinical Trial Patients With Social Media 9/7/2016

    Social media and digital media are important tools for reaching various patient populations. CROs are increasingly seeing the value of these mediums for recruiting patients and engaging with them during clinical studies. Social media can be more cost effective when compared to other advertising channels such as TV, newspaper and radio ads because of its ability to more narrowly target an audience of interest.

54. Conducting Feasibility For A New Clinical Trial 9/7/2016

    Most often, the question is “How many sites will we need to meet our enrollment target and timelines for this study?” Of course, this is an important question, but asking this question can be putting the cart before the horse. The foundation of a successful study is a protocol that is both scientifically sound and viable from an operational perspective. Assuming the former has been sufficiently vetted, the first goal of conducting feasibility should be to test the assumptions of the latter.

55. 4 Things To Consider When Implementing ePRO And Smart Devices In Clinical Trials 5/19/2015

    Depending on your phase of development and the type of data you are collecting, validation may be required. The first question you should ask is “what stage of development are you in?” If you are using ePRO for a pivotal trial or the data is likely to be used in a marketing application submission like an NDA, it is highly likely validation is necessary.

56. Improve the Inclusion & Exclusion Criteria for Your Next Clinical Trial 5/14/2015

    Adherence to inclusion and exclusion criteria is essential to the successful execution of a clinical trial. Deviations from these criteria must be avoided because they can jeopardize scientific integrity, regulatory acceptability, or the safety of subjects in the study. In this webinar, Dr. Modell will provide suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments.

57. Which Type Of Contract Is Right For Your Clinical Research Project? 8/28/2014

    You’ve Chosen A Contract Research Organization (CRO) to partner with on your next clinical research project or program, and now it’s time to sign a contract. By Jamie Hahn

58. Objectives And Considerations In Developing An Integrated Summary Of Efficacy (ISE) 8/28/2014

    A new drug application (NDA) covers information about a product from inception through clinical trials. By Ben Vaughn

59. Key Tips For Orphan Product Development 8/28/2014

    Selecting a partner for drug development is tricky. This is especially true when selecting a CRO to assist with orphan product development. Dr. David Shoemaker

60. Could Your Phase II Or Phase III Clinical Trial Benefit From A Special Protocol Assessment (SPA)? 8/28/2014

    Special Protocol Assessments (SPA) are an opportunity to get upfront input and buy-in from FDA on the scientific, regulatory, and statistical rigor of your planned adequate and well controlled clinical trial. SPAs can be done for clinical protocols, non-clinical carcinogenicity protocols, and CMC stability protocols.