I think they should put more emphasize on just making sure the person can think critically and actually has a background in research. If you read publications such as “Embracing failure: What the Phase III progesterone studies can teach about TBI clinical trials”, you will learn about a particular example of a Phase 3 clinical trial that failed in my opinion, due to poor planning. This trial was a huge blow to the Traumatic Brain Injury research community. It planned to involve about 1,000 patients but they had to stop short due to the trial being that much of a failure. As outlined in the publication this was due to people not planning the trial reflecting the research that is already out there. It was almost like someone who had no actual background in research planned the clinical trial. It didn’t take any past research into account and of course, it was a complete and utter failure. I’m sure they had a CRA professional involved considering the size of the Phase 3 trial and the money spent and I think this is a prime example of people who might have the clinical background but couldn’t think critically through a problem and actually plan a trial that made sense. If they knew anything about TBI they would have known to separate patients by the way the TBI was induced. They would have understood that a different secondary biochemical cascade is initiated based on this and no, you can’t just treat every secondary biochemical cascade with the same drug.

This is an interesting question! I agree with most of the participants that having clinical background is a plus, but again it depends on the type of role within the CRA profession. For example, Statistician might not need as much medical background as Principal Investigator because they are mostly working with the data and analysis. Principal Investigator is primary contact and provides specific information regarding complying to FDA regulations with the clinical trials. There are many documentation, critical deadlines and regulations that the industry professional like nurses and doctors have practiced and it is critical for them to know the clinical background information. However, depending on the individual’s role it may be an advantageous if everyone involved in the clinical trial is aware of at least the risk involved.

Clinical background is not required for all functional roles in a clinical study as stated by many in previous posts, although I think it is critical to have experts with clinical background in the study depending on the type of device/ combination product being studied. For example, a study in which the objective is to evaluate an implant will definitely require physician(s) trained and qualified to perform implantation and removal procedures. 21 CFR 812.43(a) states "A sponsor shall select investigators qualified by training and experience to investigate the device." An investigator does not need to be a medical doctor. A physician can be a subinvestigator to perform those study functions requiring the appropriate level of medical expertise.

I would start out by saying the obvious, which is that since companies are willing to people as a CRA without having any clinical background would mean that it is not a complete necessity. On the other hand I do think that the specific role you are performing in the clinical research field could demand more or less of a clinical background. For the roles that are related to performing data analysis (statistics, etc.) I do not really see any benefit from having a clinical background. For the roles that are related to writing protocols and other procedural related activities I definitely see a major benefit to having a clinical background. In my opinion having a clinical background to perform these procedural related tasks is invaluable. I believe that the real life clinical experience cannot be duplicated by any classroom or educational related knowledge, and allows you to be create more accurate and efficient studies.

Having clinical trial experience is definitely advantageous in the medical device field as you encounter problems that may not have been thought about during the design of the product, and gives good insight into human factors of the product. After completing my BS degree I actually worked at a pain management clinic as a clinical research coordinator, in which we conducted a variety of studies such as spinal cord stimulator trials, pharmacogenetics programs, and pluripotent stem cell injection trials. Throughout these trials the main responsibility was identifying, monitoring, and recording input of the patients throughout the trial while also understanding the technical aspects of the study and relaying any new information from the sponsor (company) to the investigator (clinician). For the most part our key sponsors included Stryker, St. Judes Medical, and Boston Scientific gathering data. We also participated in prospective studies through federal sponsorship on opioid abuse and it's relation to pharmacogenetics in order to find a correlation between the two. The most interesting aspect of clinical trials is the interaction with the patients and getting direct feedback on the product. My time in a clinical trial setting definitely helped me to gain a better understanding in patient needs and a different perspective into medical devices.

Clinical experience is not needed for all the roles. Roles which does not involve any interaction with patients, communication with patients like statistician etc does not need any clinical experience. But for roles which is directly involved with patient interactions like nurses, physicians etc, having a backgound of clinical experience becomes essential. They will have to communicate with patients in order to do their jobs and help patients.

I think having a clinical background is very useful specially when you are dealing with the patient in clinical trials as a Bio-medical Engineer, I worked as a patient sitter in the hospital for 2 years and I also currently work as an EMT and from that I can say that It requires a lot of Patience and not every person is same you have to deal with every patient differently based on their needs the key is to that is win the patients trust and that will make your life much easier. Their are biomedical companies out in the market who specially hires nurses help in clinical studies where they can deal with the patient and again patient will trust the nurse or doctor(because they are the center of Medical Profession) more than the engineer. And of course it depends on you job description as a Biomedical Engineer as Principal Investigator and CRA I will say you should have some experience how to interact with the patients and most important how address their needs keep in mind the main goal of the study and not catch feelings for them but instead work with them help them and don't give them wrong hopes but at the same time don't be rude. On the other side as a monitor and Statistician you don't interact with the patient directly so I will say you don't need medical background but it will be good to have it because remember you work as a team in project and your experience might be helpful.
Reference:-
https://www.indeed.com/q-Clinical-Research-Nurse-jobs.html

A background in clinical studies should be required depending on the profession and work environment. For example, a Principal Investigator (PI) is the "primary individual responsible for the preparation, conduct, and administration of a research grant or other sponsored project in compliance with applicable laws and regulations" and for this reason they should have a firm understanding of clinical procedures and studies. Additionally, any professions involving patient interactions should demand a clinical background in order to effectively treat individuals. One way to ensure and test the clinical knowledge of healthcare professionals is through the Objective Structured Clinical Examination (OSCE). This exam is an "evaluative tool that can be utilized to assess health care professionals in a clinical setting". This is a very accurate way to measure clinical competency since it tests the knowledge of individuals through direct observation. Some professions may not require this kind of testing - such as Monitors and Statisticians. However, for those making a direct impact to healthcare, it is necessary to have a clinical background.

References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3191703/
https://www.umass.edu/research/policy/pi-and-co-pi-roles-and-responsibilities

I feel that, while not necessary, it is very advantageous to have a clinical background in the role of a CRA and especially in the role of a principal investigator. The reason for this is that a clinician has been trained to understand the day to day operations in a clinical setting, and have been directly involved in the administration of care. This is an invaluable perspective that not only brings to light the issues within the system, but also the special considerations which are not readily apparent. Of course, this can be substituted with clinical consultants or collaborators.

I don't believe it is completely necessary to have a clinical background to work in this field. To say you need have a clinical background for a role is highly limiting the talent pool that would potentially be interested in the company or role. Engineers that are solid in solving problems, have an extensive background in math and science, and have worked in medical device or pharmaceutical industry, would be excellent candidates for these roles. The part that is lacking, is the interaction aspect of working with patients. However, I believe this can be learned on the job or through training and possibly seeing if they acquire a certain certification. This doesn't need 3-5 years of clinical background experience. There are engineers that work for companies that I've personally seen who are just as qualified or can be easily qualified to work with patients and administer or coordinate clinical testing and research.

A clinical background is a very valuable trait when considering the field of clinical research. While engineers and technical experts are capable of working in this field, and successfully so, having a greater depth of knowledge in the intricacies of the human body (anatomy, physiology, pathology, immunology, pathophysiology) allow for a more targeted and informed approach to solving problems and issues. Again, a subject matter expert in a field such as immunology may have knowledge of everything needed to develop a vaccine, but it requires guidance and a knowledge of the subtle interactions within the human body and effect on patients that will allow success and minimize risk. Clinical knowledge is important and valuable at the highest levels of clinical research, but it should not be a barrier to entry. There are many roles within the field that can be filled and operated successfully by individuals without the same depth of clinical knowledge as a practicing physician or nurse.

The CRA is responsible for initiation ,conduct of clinical trials and ensuring that scientific data have been collected and protecting the right and safety of patients. CRA should have a medical background because they are familiar working with patient health chart and clinical health records and they understand data collected during studies General educational qualification for CRA is typically a medical background ,However people having skills like leadership, negotiation, presentation skills, administrative skills and knowledge of GCP can also be CRA. Ability to travel also play key role CRA's expected to travel to various research sites and have ability to handle domestic as well as international sites is key skill for CRA role. In order to expand knowledge without medical background to meet the specific requirement there are several trainings.

Asking for clinical trial experience is just asking for job experience. If you apply for a systems engineering job, the company would want systems engineering experience. It is the same thing. Companies always want to hire people who are familiar with the responsibilities of their job. With clinical trials, it is arguably more important because the financial risks are greater. If malpractice happens, the inevitable lawsuit is tremendous. Of course, if you are the statistician, you are not going to be interacting with the patients that much and wont need as much "clinical experience" as compared to "technical experience". This is because your job description is different than an investigator's or assistant's. The company is really just looking for experience in the role you applied for.

I believe that there should be some type of clinical background when going into the profession because then you know what you’re working for. There should be at least some research done. When you have a clinical background, it makes it easier to work with patients and see where the products are going. Without this experiences, it can become harder to relate to the patient. This also depends on the position you have. Clinical studies and working with patients closely in the hospital require a clinical background because you have to know how to talk to a patient and saying the wrong things could disrupt the clinical trial or the treatment the patient could potentially be getting. You also have to know how to calm the patient down as well as their family members. Someone who is brand new to this will have a difficult time calming the patient down and could make the patient even more nervous and anxious than they already are. This skill also takes a long time to learn when you’re just starting off. It’s definitely an uphill battle for those without the clinical background but starting off earlier on can help especially with internships and jobs that will take a chance on you to help you learn. However, if you are working as a scientist, I do not think a clinical background is required because you have other coworkers to help you through everything and you have a lot of training and reading that is required in the position that it is easier to pick up.

When it comes to handling clinical research I think it is a necessity to have some sort of clinical background or to have undergone a period of clinical training and observation before you can be in a clinical setting. As discussed in the lectures there are a number of adverse events and effects that can happen to the patients in the study. The Clinical researcher should have some experience in handling similar events or knowing how to learn about handling such events so as to protect and assist the volunteers. Also, when dealing in a hospital setting you have to be used to the environment, knowing the daily practices and routines that occur and knowing how to communicate with other doctors and medical professionals in the clinical experiment. In addition, being able to fully understand what the patient is trying to describe to you is important. If you have no experience you may not know what the patient is even talking about when they are describing how they feel, you may not know what are the right questions and follow up questions to ask, and you may not record the proper information for the study.