While often touted as a way to improve clinical trial recruitment and retention, including patient-centric features before and during the design phase of a study has many more benefits. Among them: better protocol adherence, data that reflects real impact on patients’ lives and greater likelihood of a new product being approved for marketing. Read More
Clinical trial professionals and academic organizations have long been cautious about the safety and legal liability of including pregnant or lactating participants in studies. But a recent report from the National Academies of Sciences, Engineering and Medicine (NASEM) finds limited evidence to support those fears.1 The report also warns that the lack of evidence available to these patients and their doctors about using a drug or vaccine poses greater potential harm than including them in research would. Read More
Oncology trials often lead the research innovation pack, from deploying diverse data sources to using novel recruitment methods to embracing new trial designs. While some advances are specific to cancer research, researchers in all fields can look to oncology studies to improve their own trials, especially when it comes to patient centricity and harnessing the power of new tools and strategies.
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Inclusion of appropriately diverse trial participants has been a concern for well over two decades. But in recent years, diversity among clinical trial participants has become a growing concern for sponsors, regulators and researchers alike. Read More
Principal investigators, study coordinators and other members of research teams are learning that sponsors are reaping the biggest benefits of decentralized and hybrid trials, such as lower long-term costs. Meanwhile, sites are bearing the burden of up-front costs and increased demands on staff. And evidence that the model has a positive impact on patients is mixed. That’s led some in the research community to wonder: Is the model all it’s cracked up to be? Read More
Clinical researchers could avoid the bulk of FDA inspection issues that might impact their organization by following study protocols to the letter and making sure documentation and record-keeping practices are beyond reproach. But that’s easier said than done. The growing complexity of clinical trials, ever-expanding data points, new management technologies and differing experience levels among staff all combine to make this a challenge. Read More
Excellent communication within a clinical trial’s team is one of the most important factors in determining success. If communication is poor within and between departments and individuals, the primary goals of the study – adherence to the protocol, patient safety and data quality – could be put at risk. Conversely, strong communication can address many issues that can improve trial quality, including reducing staff conflicts and increasing performance. Read More
Any successful clinical trial begins with a solid research plan that lays out the research project, its importance and how it will be conducted. It can include everything from big-picture objectives and methodologies to details about equipment and personnel requirements, but if the plan is incomplete, unclear or inaccurate it can result in delays, budget overruns, protocol deviations or errors that render data useless. Read More
Endpoint adjudication — a standardized process for ensuring that assessments of the safety and efficacy of the investigational product are consistent, objective and unbiased — add new stakeholders, procedures and unique considerations to a traditional trial as well as increased attention from regulators and sponsors. Read More
While sponsor contracts often include some study closeout provisions, sites should have their own closeout process in place, driven by a checklist to make sure all regulatory, sponsor and IRB mandates are met, experts agree. Read More
