Featured Articles
-
FDA Expectations For Diversity Inclusion In Clinical Research
5/24/2017
The trend toward increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.
-
FDA Guidance On Non-Inferiority Clinical Trials To Establish Effectiveness
5/24/2017
In November 2016 the FDA released final guidance on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. The guidance does not provide recommendations for how to evaluate the safety of a drug using a non-inferiority trial design. This article provides background on a non-inferiority trial design along with assumptions and advantages and disadvantages of the trial design.
-
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.
-
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.
-
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.
-
How To Enhance Efficiencies In Clinical Development And Market Approval
9/7/2016
Once a sponsor has completed research and clinical trials and believes enough evidence is available on the safety and effectiveness of the new drug, the final step of the development process is to submit an application to regulatory authorities to gain approval for marketing the product. The application must contain data outlining the technical specifications of the product, as well as statistical analyses demonstrating the safety and efficacy of the new molecular entity as evidence of the acceptable benefit:risk profile.
-
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.
-
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.
-
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.
-
Addressing Diversity In Clinical Trials: Clinical Research Services
3/17/2015
A recently released food and drug administration (FDA) report encourages enrollment of more women and minorities in clinical trials. The report identifies three priorities in order to address this need: participation, data quality, and transparency. Clinical research organizations (CROs) can help guide sponsors in all of these areas in order to ensure that their drug and device applications not only meet all of the current requirements, but that they are at the forefront of the direction of the FDA and of biomedical research as a whole.