Clinical research is beginning to see a rise in consolidation of sites which could have an impact on budget negotiations. This video features a guest who sees the changes that technology has had through the various cloud based systems that are currently available to sites. Technology has also allowed sites to reach out directly to patients for recruitment.
Dr. Kingsley, a Certified Principal Investigator talks about where he thinks the research industry is headed and how it will affect sties. He notes that research has become more complex which is a precursor for industry wide professionalization. On the topic of virtual trials, Dr. Kingsley proposes that there will be less need for sites leading physicians to see more patients.
CRO’s and Sponsors are able to use large amounts of data to identify high quality sites through the use of specialized vendors. These vendors are able to build networks of high sites who have a consistent record of performing well throughout different studies. While this may pose a challenge for smaller sites, it is important to remember that a site’s PI is ultimately the most important factors that sponsors take into consideration when choosing sites.
As research into CBD increases, regulations on this compound may change. Some businesses may be able to benefit from CBD research which can in turn open new opportunities for business leaders. This video features a guest who is highly qualified in both pharmacy and law, a powerful combination which can shed light into the future of CBD research.
Sponsors must show that there was an element of oversight on their behalf during clinical trials. For this reason monitors are hired to perform tasks such as Site Data Verification and Site Data Review. SDR may be one of the most crucial activities that a monitor performs and it requires a high level of attention to ensure protocol and GCP compliance.
Site owners who can’t find or can’t afford to pay for an experienced coordinator must find an employee to train . Training can take a long time but things such as the employee's education and motivation can greatly affect the learning process. The early stages of training should focus on SOP’s before moving to regulatory or source documents.
Many people are unfamiliar with the process in a study drug must go through before it can enter the market. Sponsors must initiate this process by first filing an IND application to the FDA. After the IND application is approved sponsors can begin the arduous task of collecting data that will hopefully show safety and efficacy.
A typical PI at a research site has different options for their continued involvement in the research industry. Most PI’s are content with running studies and practicing medicine at the same time. However, there is a small percentage of PI’s who will advance to a level in which they design protocols and take the role of a sponsor.
The definition of clinical significance should not be up for debate. The PI is the person responsible for deciding what is actually a clinically significant finding in a subject’s chart. Clinical significance should not be confused for causality, which typically relates to an AE’s relationship to the study drug.
Preparing site training documents and certifications is one of the few things you can do to prepare yourself for a SSV. Doing this type of preparation can help ease some of the stress that sites experience, but once the SSV begins it is important to show your site’s level of professionalism. Doing so can help the visit move smoothly and allows the CRA to collect the information that needs to be submitted to the sponsor for approval.
In this video, a highly knowledgeable PI reminds the audience that lack of PI oversight is one of the most common FDA findings. Future site owners might want take this into consideration and possibly partner with their PI’s to ensure that there is an incentive for the PI to actively oversee trials. Greater PI involvement can prevent situations where a simple AE becomes an SAE that was not detected earlier.
Physicians can decide their level of involvement within the clinical research industry. Having such freedom means that a physician can choose to simply be a PI or Sub-I at a site and stay at the lowest tier of the physician hierarchy of clinical research. Most physicians will chose this tier but a small fraction of physicians will reach the fourth tier in which a physician is developing a new product.
Dr. Sabine Hazan tell her story about how she became a sponsor for an area of research that interested her. Her story illustrates that is is possible PI to become a sponsor after enough ambition. Few PI’s will take this route but for the few that do, the possibility of learning about a new treatment has the potential to change the lives of countless patients.
Many future site owners will first focus on things such as business cards or websites before focussing on the issues that matter the most. The first priority for starting a site is to obtain a PI, preferably one with a steady patient population. After obtaining a PI, the focus can shift to obtaining studies based on the PI’s database.
Lying about your employment history is highly discouraged. Any false information that is presented during a job interview will quickly be quickly be discovered during the verification process. Instead, it is encouraged that applicants present accurate information and try to obtain the necessary skills for the job they want prior to applying.
Remote monitoring and risk-based monitoring are two completely different forms of monitoring. Remote monitoring typically requires sites to create virtual copies of important documents for review. Meanwhile, risk-based monitoring is a strategy used by sponsors to focus on sites that are identified as having low data quality.
With the release of the book “The Comprehensive Guide To Clinical Research: A Practical Handbook For Gaining Insight Into The Clinical Research Industry,” a wide range of research topics has been condensed into easily digestible pieces of information. This video provides an additional resource for those seeking to enter the research industry by providing an outline of the topics covered in the book. You don’t have to be new to research to find an interest in this book however, since people with an understanding of the research industry can easily find critical pieces of information that may have changed or require attention.
Clinical research oncology is different from most psychiatric research trials. Monitors who are accustomed to psychiatric trials may need to learn new vocabulary and must keep up with constantly changing information such as AE statuses. Oncology is certainly a challenging area of research but there are many aspects that remain similar such as AE tracking and providing patients with informed consent.
A typical day for a study coordinator involves several responsibilities such as meeting with patients and completing source documents. Sites can always accept interns who can be paired up with coordinators and can learn a coordinator’s responsibilities. Offering this opportunity allows interns to get a better understanding about the research industry but also requires sites invest some amount of resources away from typical functions in order to educate the intern.