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.
Sales come in many forms. In research, sites must be able to sell themselves to sponsors by focusing on their strengths. One of the greatest strengths a site can have, regardless of how inexperienced the site may be, is access to potential patients.
One of the first things that new sites need to consider when starting a new site is who their PI will be. It is advised to start with a family practice, internal medicine, or any other physician who has experience in a wide range of indications. This recommendation is not a requirement and new sites should not be discouraged if such a physician is not available.
As with any business, research sites are vulnerable to unforeseen events which may put the business at risk. It is therefore advised for them to seek premises liability coverage. Other protections exist in the form of medical malpractice insurance and indemnification which is usually included in contracts with CRO's or sponsors who are managing a study.
SMO's were ubiquitous in the research industry until it was found that their focus had moved away from producing clean data. After such discovery, SMO's became less popular and CRO's rose to meet the needs of the sponsors. Now that sponsors needs are changing again, it seems as though CRO's will see some competition from SMO's.
Being involved with regulatory is one way to learn what is needed to become a CRA. Even with adequate knowledge, there may still be areas in your history which may prevent you from landing a CRA position. People who are serious about becoming a CRA will find a way to enter the profession even if it means having to move to the coastal areas which often have more sites and more employment opportunities.
The CRA position is considered to be a well paying and respected occupation that demands a great deal of attention to details. Potential CRA's may be interested in learning the benefits and downsides of the profession. This video gives an excellent perspective of the pros and cons of being a CRA from the point of view of an experienced CRA.
The best way to bring patients to your site is to use a combination of recruitment advertisements as well as advertisements for your site's brand. Savvy negotiators can present detailed branding plans to sponsors who may then be willing to allocate funds to your site. Branding plans should be considered as a long term strategy to recruit new patients.
Research sites know that advertisements can help bring new patients with the potential to randomize at the site. Sponsors are aware of this and they will often provide marketing campaigns to promote patient enrollment. This video provides a discussion of the benefits and potential drawbacks of advertising campaigns.
All research sites are aware that they must devote resources to patient recruitment. What most sites don't consider is that they should focus on branding their site as an expert site in a specific indication. Branding allows patients to become aware of sites and allows sites to avoid having to advertise for specific studies.
There is a long list of requirements that sites must consider before adding a new study. This video provides an overview of the different requirements from sponsors and CRO's in order to help sites prepare. Required regulatory documents are also explained for the benefit of research naive individuals.
Most coordinators will agree that when it comes to lab kits, having too many or not enough is a frustrating reality. Having too many kits at a site is a problem is because they require a large amount of space which most sites don't have. Fortunately, sites may be able to include a service that can reduce lab kit waste by simply including it during budget negotiations with sponsors.
Trial Master Files are a collection of essential document copies collected from all sites involved in a particular study. Sponsors must constantly update and maintain of these files, typically through the use of electronic platforms. Anyone interested in becoming a regulatory document specialist for a sponsor must have a good understanding of regulatory documents and electronic platforms such as Intralinks VIA.
Few sponsors have begun to investigate how the patient experience affects sales. Sponsors that choose to do so may begin to identify which products to focus on based on side effects and patient feedback. Some sponsors may look at patient groups for potential feedback sources but must do so with care.
Academic research is often seen as being less appealing than private research. However, academic research may actually require a greater level of organizing in order to maneuver through the requirements of both sponsor and academic institution. One of the strategies that has been implemented by an academic research site is to leverage electronic signature software that can be used by physicians.
People who are new to the industry are advised to constantly go above and beyond what is expected in order to learn a wide range of valuable skills. This is because the research industry is large and demands individuals with a wide range of experience. It is therefore possible for a coordinator at a research site to enter another area of research as a project manager or a monitor.
Of the many ways a site can lose a study, losing a study due to poor data quality is something that should never occur. The simplest option to ensure data quality is to have another coordinator review the first coordinator's work. If this option is not available, sites should hire someone to conduct a QA review.