One key challenge in clinical trials is patient access: reaching the right patients, ensuring easy access to trials, and making it easy for patients to continue participation. The industry is undergoing a shift in this regard. Historically, clinical trials were perceived to be focused on scientific outcomes over patient experience. The patients and their perspectives weren’t factored into the whole process of therapeutic development ..read more

Research sites in China can now use StudyTeam software to manage patient recruitment and enrollment in clinical trials more efficiently.  ..read more

According to a pharma FDA auditor, the biggest issue for compliance in clinical trials is oversight by principal investigators – or the lack thereof. As the principal investigator in a clinical trial, you are responsible for overseeing and managing various aspects of clinical research including data collection. Historically, this oversight can be tedious. Manual data entry can lead to errors and increased workloads. You have to continually ensure the accuracy and integrity of data that’s collected – in addition to the confidentiality and security of that data. You manage this all wh ..read more

Clinical trial screening is one piece of the overall patient enrollment period. The screening phase immediately follows the recruitment period, during which a potential candidate has gone through pre-screening, has gotten their first visit scheduled with the research team and has learned more about the trial and about informed consent. Now, screening stands between that trial candidate and official enrollment. But what is the difference between screening and enrollment in clinical trials ..read more

PhD student and medical doctor Dr. Elise Jonasson Nielsen works at the department of hepatology and gastroenterology at the Esbjerg Hospital, University Hospital of Southern Denmark. Jonasson takes on a variety of roles within her team depending on the study the site is focusing on. She is the manager of one study looking at the brain function in patients with liver cirrhosis; in another multicenter study, she will be primarily working on finding the right patients to include in the trial. Based on her experience, Jonasson offers insights into her team’s clinical trial workflow, challeng ..read more

When you ensure your clinical trials are set up to enroll a representative patient population, you’re more likely to keep timelines and goals on track across your portfolio. Strategically enrolling a representative population from the start prevents recruitment delays, improves the validity of trial results, and reduces the need for postmarketing data collection to confirm the success of your FDA Race and Ethnicity Diversity Plan.  ..read more

The FDA’s 2013 guidance for electronic source data capture promotes the use of eSource in clinical trials to streamline investigations while improving the reliability, quality, integrity, and traceability of data. eSource platforms enable sites to capture all or some data for patient visits electronically, including medication logs ..read more

Meet research coordinator Anne-Helene Boivin of Centre Hospitalier de Mont de Marsan in France as she shares a quick look into the clinical trial workflow at her research site, including a few tips for other site teams. Boivin manages and coordinates the various stages in the implementation and follow-up of clinical studies, in cooperation with the medical and paramedical teams in the clinical and technical departments ..read more

Within the FDA’s guidance document issued in August 2023: Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products, the FDA recommends sponsors “present information from premarket clinical trials on the safety and effectiveness of drugs in terms of gender, age, and racial subgroups” while including underrepresented patient populations. The recommendation continues: “However, if, despite the sponsor’s best efforts, these populations are not adequately represented in premarket clinical trials, it may be appropriate to collect s ..read more

As leaders in clinical research, sponsors can have the ability to drastically reduce clinical trial site burden ..read more