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
A clinical trial is far from done once the last trial participant completes the last visit and the database is locked; there’s still a long list of tasks and procedures to work through, from accounting for leftover investigational product to wrapping up final reports. Failing to conduct all of those closeout activities can put a site out of compliance with FDA regulations, IRB requirements, the contract with the sponsor or even their own established policies and procedures.
Clinical trials are all about the data, but when that data includes participants’ protected health information (PHI), researchers, study coordinators and other staff must ensure that they are compliant with a growing myriad of patient privacy laws and regulations.
From stem cells to psychedelics, novel areas of medicine are spurring change in the clinical research industry. New investigational areas — such as precision and personalized medicine, cell and gene therapy, regenerative medicine, nanomedicine and alternative therapies, such as cannabis — will require new techniques, technologies, trial designs and skills.
The word “innovation” is almost synonymous with the word “change,” but the former has a positive feel while the latter can have a negative connotation for risk-averse individuals and organizations alike. With the clinical research industry being both highly risk-averse and in need of innovation, sites and sponsors can benefit from establishing strategies to take the sting out of change. Read More
The word “innovation” is almost synonymous with the word “change,” but the former has a positive feel while the latter can have a negative connotation for risk-averse individuals and organizations alike. And few industries are as risk-averse or as in need of innovation as the clinical trials field. Read More