Having knowledge about clinical research is an extremely valuable asset in the industry. However, the simple fact that a person is aware of certain ideas in research does not guarantee success. This is evident by the fact that site owners and CRA's can quickly be trained in the ideas behind research but additional opportunities must be given to obtain experience.
The IRB plays a crucial role in addressing patient safety during the length of a study. One of the problems that IRB's face is that they must review deviations that are not relevant to patient safety and are instead submitted at the request of overly cautious monitors. Even though they receive high volumes of deviations, boutique IRBs are able to offer a individualized assistance their customers who are attempting to complete the protocol review process.
Patient recruitment can come from efforts outside of advertisements and referrals from physicians. One alternative method to improve recruitment is to create an audience centered around a specific indication and educating the audience on the importance of research in the specific indication. Doing so allows sites to become engaged with a wide range of people who are interested in a specific indication but who are not informed about clinical research.
Having a good PI isn't the only way to improve a research site. Sub-I's can actually be a great addition to sites where the PI has limited availability or where the PI has a heavy workload. Additionally, the type of Sub-I that joins the site can vary from being a Nurse Practitioner, Physician's Assistant, or Medical Doctor but will invarialbly provide a benefit to the site.
Many people rightfully assume that the CRA position is an attractive career to apply to. Applying to the CRA without actual knowledge of the research industry can result in being blacklisted by various companies. One way to acquire knowledge about the industry is by applying to Clinical research assistant positions or simply by becoming a recruiter.
Sites that are trying to get new studies must learn the basics of sales in order to appeal to sponsors. Site should be aware of their own strengths and weaknesses as they pursue new studies. After obtaining a study, sites must be able to leverage their history and quality of data to negotiatie the best budget.
Digital twins currently serve as models for mechanisms such as engines but may some day be adapted to human models. If such an advancement should occur, the research industry may see a great change in the way that patient recruitment is conducted. As the guest in the video suggests, digital twins may be so effective that they may be able to reduce the need for phase 1 research.
In this video, a future site owner advises everyone to first be a coordinator and learn about the industry before opeining a research site. Having CRC experience allows site owners to audit their own sites and keep from being a red flag site. This is in contrast to new owners who are sometimes confused by acronyms such as SOCRA or CRO.
Dan Sfera gives an entire lesson on SQV's, SSV's, and PSSV's. The lesson provides insider tips on what sponsors want to know when selecting a new site. Sites are advised to have site metrics available both before and during potential PSSV's.
New sites must be patient and allow time for sponsors to review SIte Selection Visit reports. In the meantime, special attention should be given to improving ability to manage time effectively. Site owners must also consider what changes the site needs to make in order to make the site more attractive.
Sites must have the capacity to accommodate study specific requirements as needed. Fortunately most studies have similar requirements such as having enough space for patient charts and monitoring rooms. New sites that don't have all of the requirements for a new study must make efforts to explain that during a site selection visit.
Facebook is an underused tool that can attract a lot of people to your site. For this reason it is important for business development to maximise the use of facebook ads. Facebook is able to target whichever demographics you ask for and has an cost effective option to charge per click.
Enrolling patients is one of the most important part of running a site. For this reason, the business development department must be able to recruit patients for their site. Some sites have discovered ways to target specific groups by creating environments that attract target populations.
New sites are sometimes unprepared and may need additional guidance to ensure that essential documents such as IRB approvals and source documents are available. After such documents have been secured and monitoring visits have occured, deviations will most likely be uncovered and sites must make sure that these are addressed immediately. From a business perspective, new sites may want to consider finding studies of various indications in order to gain expereince.
Developing a CRO takes a long time and learning about supplying sites can take even longer. Wen it comes to supplying lab kits few people know how complicated lab kits can be and even less people know just how much sponsors pay for lab kits. One of challenges of starting a CRO is struggling with the fact that insurance for clinical research can be hard to find and can even be expensive.
The Guru provides a one on one lesson to a CRA Academy student. The student in the video is able to demonstrate knowledge in clinical research. Some of the topics covered include PI oversight, the S.T.A.R. method, and regulatory document basics.
Many physicians are not confident in clinical research and may have misconceptions about adding research to their established, medical clinics. Interestingly enough physicians who are involved with a clinic tend to have a relationship with their patients and are in a position to identify patients who may benefit from participating in a research study. Physicians who are not familiar with research tend to be concerned with liability, but most liability issues can be avoided by focusing recruitment on patients with a history of adhering to treatment instructions.
The role of Sub-I is often overshadowed by the more demanding role of PI. Newer sites can take advantage of this situation by offering the role of Sub-I to physicians who are not involved in research. It is important to frame the position of Sub-I as an opportunity to gain prestige, build a strong CV and add another stream of income.
Clinical research is often overlooked by people in the medical profession. The reality is that the clinical research field offers a variety of stable and high paying positions. Many of the physicians involved in clinical research supplement their income by being active at a site.
It is possible to switch a PI with a Sub-I as long as sponsor approval is obtained. Sponsor approval will usually depend on how the sponsor perceives the Sub-I to be qualified in order to oversee the study. If sponsor approval is not obtained, the Sub-I can continue to be a part of the study team and can still contribute to other studies.