In a presentation at the Science of Cancer Health Disparities Conference these past few days, researchers highlighted results from a recent study which videotaped the way oncologists discuss clinical trial options with their patients. In this particular study, 22 video recordings in which a clinical trial was offered were analyzed of oncologists discussing clinical trials with their patients, 11 of whom were white and 11 of whom were black. Not surprisingly, as studies were done on this in the past (however this is the first study that utilizes real time data), African Americans were spoken to overall less than their white counterparts. African Americans were also offered clinical trials less than Whites in this analysis. Informed Consent of the study was also explained less to blacks than whites. The study also shows, and previous studies confirmed, that black patients also ask their physicians fewer questions and overall speak less than the white patients which were analyzed.
One of the researchers, Susan Eggly, PhD, commented, “Minority patients tend to receive less information, which could, in part, explain under-enrollment by minorities in clinical cancer trials, these disparities could also lead to minority patients being enrolled in trials without fully understanding the purpose of the trial and the potential risks of participation.”
The reason for the lack of minority, specifically African American, participation in clinical trials has been looked at and discussed before. In fact, I did an interview here with someone from John Hopkins University on the reason African American lack trust when it comes to clinical trials. The key seems to stem from an adequate lack of communication between physician (usually white) and minority patients. Whether this can be changed by better educating physicians on how to include minorities into these conversations, or simply encouraging more minority youth to pursue a career in medicine, the current result is that there is an obvious problem here that needs to be repaired. For more information on the study I am writing about, please check it out here. As always, let me know your thoughts.
The Study Coordinator is the backbone of any protocol. You know this by now. So does your research clinic’s ownership. So do the PI’s, so do the Monitors. The Study Coordinator themselves know this as well. So how does the Site Manager effectively manage the study coordinator without being too controlling, imposing, or downright tyrannical? Develop a solid foundation for your relationship, and do so early in the relationship. From Day 1. This means teaching the study coordinator how to perform his or her duties until they are comfortable doing it. This means doing the duties with the coordinator until they feel comfortable doing it on their own. Once this objective has been reached, you may step back and provide guidance and support for the study coordinator, in addition to serving as a Quality Assurance manager. What does this support mean, and how can it be leveraged to gain the respect of the study coordinator? Once the study coordinator is comfortable in his or her role, the Site Manager MUST be present throughout the entire day to actually provide support. The coordinator must feel as if you are standing by their side fighting their daily battles with them, and not leaving them alone on the battlefield. If the coordinator is having a particularly busy day, offer to help with simple tasks such as dry ice for them, as well as getting food and/or snacks for the study participants that day. If they are having a monitor the same day as having patient visits, talk to the coordinator about how you will help them that day. The coordinator should not feel as if you are above their line of work, and you should NEVER ask a coordinator to do something that you would not be willing or able to do.
You will never develop a good relationship with the coordinator if you are not willing to teach them, mentor them, provide guidance and support for them. It is also impossible for you to do any of these things if you are not present in the office the majority of the time. There is no exception to this rule. A Manager who is not present in the office is a useless manager. Being available by phone is not an option. That is the fastest way for you to lose the respect of the coordinators as well as the ownership of your organization. Cases such as these will probably be dealt with promptly. Part of being a manager requires you to display humility despite being placed in a position of power. Managers who abuse their powers do not have the respect of their coordinators, instead they rule by fear. Managing with fear will not fulfill your most important objective which is to KEEP EVERYONE HAPPY!
Because of the importance of study coordinators at any research clinic, coordinators should be given quarterly questionnaires where they will rate their relationship with the Site Manager. These should be reviewed by ownership on a quarterly basis. Furthermore, one of the other duties of the Site Manager is to document training that he/she has accomplished with the study coordinator. Site Manager will also give quarterly reviews of study coordinators, and these will be reviewed by you and the Coordinator on a quarterly basis.
At the end of the day, your relationship with the study coordinator should be win-win. If they do a good job, your metrics will show that you are also doing a good job as Manager, and vice-versa. In order to gain trust and respect of your employees, you must be present at the clinic daily, must be willing to fight their battles side by side with them when necessary, but must also be able to provide direction in times when study coordinator may be misguided. Establishing a level of trust and respect with your employees is the only way to guarantee success as a Manager. Once that trust is gone, the success will evaporate, and you will probably no longer be a Site Manager.
Today’s guest post comes to us from Stacey Carmody, a clinical research coordinator with tons of experience who has also written posts for this website here and here. If you would like to contribute blog posts for this publication, please email me firstname.lastname@example.org.
“You Do What for a Living?” Explaining the Profession of a Clinical Research Coordinator
Stacey Carmody, CCRP
When I tell people outside of the healthcare field what I do for a living, they often reply, “Clinical research? Oh, that sounds interesting.” It sounds interesting to them but it is apparent that they are not familiar with this profession as much as other healthcare professions such as nursing. This is probably due in part to research taking place in the background on the stage of patient care. Unless a patient is enrolled in a clinical trial, the patient will not see research staff as they would a “frontline” person such as a doctor or a nurse.
Another factor to consider is that the job of the “clinical research professional” is a relatively new career. In the early days of medical research, work was done by physicians and their nurses and scientists. The title “Clinical Research Coordinator” simply did not exist. As awareness and the rules governing research evolved, so did the roles of those who entered the field. By the mid- 1970’s, a certification agency and professional organization was established specifically for those who worked in clinical research. Other organizations would form soon after, as the field was emerging with new roles, new titles and new specialties.
I was not even familiar with the clinical research field until the late 1990’s. In childhood, I do not recall anyone mentioning clinical research as a profession at Career Day in school. Like many clinical research coordinators, I started out in another type of job, and kind of “fell into” this profession. Nobody I knew went to college to earn a degree in this profession. It is only in recent years that colleges are offering degrees and certificates in clinical research. Currently, coordinators come from diverse backgrounds in the sciences such as biology, nursing , pathology and pharmacology. While a science or allied health background can give you a foundation for understanding research, it does not really prepare you for the day to day duties of the field. I learned on the job, as many coordinators have.
So…back to what I tell people about what I do for a living. I explain in lay terms that what I do is enroll patients into clinical trials to see if new drugs will help them. But that’s only the tip of the iceberg. I sometimes talk about all the regulatory paperwork that I handle and explain how research is kept “in check” . I do this partly because many still have an perception of research that casts people as “guinea pigs” that get experimented on. The field is still emerging from the shadows of its dark past. I like to put what I do in a positive light.
I have hope that the new generation will have more of an awareness of what clinical research is and perhaps the occupation will be on their radar when they are deciding on a career. It can be a path to a worthwhile journey.
Once again I brought on Guest Guru Darshan Kulkarni who has been a welcome regular to the program. Darshan also runs an excellent blog of his own. Today’s video interview revolves around the topic of clinical trials in India, and how the Indian Supreme Court is at least paying lip service towards making some major reforms as far as how clinical trials are conducted there. Darshan also points out that it is still very unclear as to which of these reforms or ideas will actually materialize into real regulations in the near future. The equivalent of the FDA in India is the DCGI (Drug Controller India General), and the Supreme Court in India filed a PIL (Public Interest Litigation) in response to several groups of people complaining to the Supreme Court in regards to the unethical manner in which some trials are actually being conducted according to them. Some of the main issues at question was the actually Informed Consent process, the apparent lack of pharmacovigilance and the fact that many adverse events, serious adverse events, and even deaths were not being reported as per Good Clinical Practice. I wrote about some of the ethical issues in Indian clinical trials here. The Indian authorities are currently experimenting with some ideas such as forcing research clinics and CRO’s to have clinical trial insurance should accidents happen, videotaped informed consents, and perhaps individual Indian states being held accountable for the way clinical trials are being run in the respective Indian states. Regardless of the direction which regulations in india will turn, it is clear that US and European drugmakers are already shifting their infrastructure towards China where there is less uncertainty as far as clinical trial regulations. I wrote about this story a few weeks ago here. Either way, this is an interesting story that I will continue keeping an eye on, and as always, will report any major developments here.
According to several sources, drug giant, Johnson&Johnson slashes 130 positions out of the nearly 200 positions in its Janssen subsidiary, specifically in the Immunotherapy Alzheimer’s Unit. This comes after a massive phase 3 set of trials in which the investigational product bapineuzumab or “bapi” failed to demonstrate efficacy in these huge pivotal trials in patients with mild to moderate Alzheimer’s disease. These failures came after questionable Phase 2 results of the same compound. The Janssen division of J&J worked closely with the Elan biopharma company that discovered the product in the first place. There is no doubt that this massive clinical trial failure for bapi will impact more than just J&J. Pfizer also partnered with Elan on this trial and invested heavily in hopes that it will become a blockbuster drug. Elan itself will certainly have to go back to the drawing board. Apparently, future Alzheimer’s treatments will be focused on prevention of people with early stages of Alzheimer’s rather than treatment of mild-moderate symptoms. This is another example of how critical phase 3 trials are and why they are called “pivotal” trials. Check out my quick summary of the various clinical trial phases here. Oftentimes, drug companies gamble more than they should on these Phase 3 products as they are growing increasingly desperate for new blockbusters to replenish their drying and expiring drug pipelines that they have recently lost to generic competition. As is usually the case in clinical trials, when once promising investigational products prove ineffective, entire research programs are cut and unfortunately, hundreds of jobs get lost in the process. Stay tuned for more information as I follow what Elan and Pfizer will do next.
Today I got to interview Dr Kenneth Kim, the Founder and CEO of West Coast Clinical Trials (WCCT Global), a CRO which focuses on early phase clinical development in the areas of Internal Medicine, Allergey, Immunology as well as Asian bridging/ethnic bridging studies. What bridging studies are is simply the ability to target a specific ethic group of study participants due to the fact that some nationalities may respond to certain treatments differently than others. In the past, we have seen Big Pharma companies that wanted to perhaps market a treatment for Japanese people in Japan, to contract with a CRO like WCCT Global and conduct the clinical trial in the United States on people of Japanese ethnicity, while theoretically getting the same data they would have received had they conducted the study in Japan itself. I wrote about and did a mini video on this topic a while ago. These days, what we are seeing is Asian drugmakers, and in the case of this blog post, Korean drugmakers, creating treatments for people in the united States, and doing their own ethnic bridging studies of sorts with niche CRO’s like WCCT Global. In an official announcement last week, the Korean Drug Development Firm (KDDF) has partnered with it’s second US CRO since its formation in 2011. By utilizing WCCT Global’s expertise and first in human study capabilities, KDDF will theoretically be able to establish its investigational products in the United States by outsourcing its early-stage trials to WCCT Global. CEO and founder of WCCT Global Peter Kim was quoted in the company’s official press release, “We have been actively providing regulatory, drug development, and phase 1/2a services for Asian clients for nearly a decade, and we are extremely energized about the opportunity to work closely with Korean pharmaceutical companies wanting to develop new chemical entities (NCEs) globally starting in the US. With our access to Asian subjects, many Asian based clients can obtain their first in human data and Asian ethnic data in the same study, saving time and streamlining their global development plans. We see this as another great bridge to playing a partnering role and becoming the country caretaker for work brought to the US, as well as serving as a conduit for out-licensed compounds to Korean pharmaceutical companies. As a Korean American, I have had a longstanding personal interest in deepening these professional ties with Korean pharmaceutical companies.” In this video interview, I attempted to go into further details on what ethnic bridging studies are and how foreign drugmakers can utilize US CRO”s like WCCT Global to establish their US footprint here.
KDDF is a new drug development project established in 2011 with a collaborative effort of three healthcare-related Korean ministries. KDDF aims to advance drug development platforms and strategies and provides tailored consulting services to meet the needs of Korean investigators. One of the key activities of KDDF is establishing various channels to connect the global biopharmaceutical leaders and Korean investigators. Currently, there are 16 awarded projects in the portfolio, which span the whole drug development continuum and various therapeutic areas.
WCCT Global is a privately owned Full Service Contract Research Organization that owns and operates its own clinical pharmacology units (CPUs) that focus on early phase clinical development, Headquartered in Southern California with locations throughout the US. WCCT was founded in 1998 by Dr. Kenneth Kim, a board certified physician specializing in Internal Medicine, Allergy and Immunology. WCCT’s CPU locations and access to an ethnically diverse population allows for a wide variety of study designs and therapeutic areas including Asian bridging/ethnic bridging. With over a 150 beds in two locations and over 60,000 square feet, a well-trained and experienced staff, advanced technological procedures coupled with a Full CRO operations team and services, WCCT brings the highest quality to the pharmaceutical and biotechnology industries.