Fady,
I do agree with your statement that with multi-center studies, there is a greater chance for variability within the studies. In order to reduce variability, it is important to have the same internal staff throughout the study with proper training. This would assist in having a consistent set of data collection and analysis. In addition, having the ability to provide the SOP that needs to be followed through the study and making sure that is the case with every center. Furthermore, there is a chance that variability can come from the population chosen at random and how they can be affected differently with the device. And this may be why most companies would like to expand the number of centers to cover the population difference. So it’s a bit tough to say that a certain number of centers is enough. The line should be drawn at the point that you don’t have enough staff to run the study consistently and it still helps to maintain a quality clinical trial.

Hi Fady and Luisa,

I would agree that it is a difficult measurement to simply say that every time a certain number. However I would agree with Luisa that a study needs to be clearly defined and there needs to be enough patients in each center. I believe that one of the most important things is ensuring that there is enough patients at each center to ensure accurate data. As Luisa said, this line would be drawn when a a center when you have enough people at the center and enough staffers to correctly run the study.

-Andrew Nashed

Hi All,
Great comments, and I do agree repeatability and traceability are vital for a clinical study, and it really comes down to is how many patients can be monitored and evaluated, because as Luisa mentioned, if there are not staff members to evaluate a clinical study, then the quality of the trail may diminish. Patient evaluation is very vital during these studies, because potential flaws due to drug or device use can be addressed. One last interesting consideration is the sampling of the patient population, like how similar to eachother must the patient population be or more importantly what variability is needed within this population to prove that the device or drug being tested is considered a good representation for the general population.

Chris

It also important to consider that a multi-center clinical study is more complex -in terms of coordination, quality control and data management- and very expensive in terms of personnel and resources. therefore it is essential to have an efficient central coordination of all trial activities and adequate funding since the beginning. it is essential to design a common protocol that should be clear and similar for all centers, also the procedures should be completely standardized for all. To reduce variation of evaluation criteria and schemes, investigators meetings, proper personnel training (as Luisa said) and closely monitoring during trial shall be implemented. Also, as Chris said, a good design should generally aim to achieve the same distribution of subjects to treatments within each center and management must maintain this design objective.
I certainly believe that in a multi-center study, it is not about how many are considered too many or sufficient, I think that the line is drawn when a budget is allocated towards this study. It all depends on how much money or how much funding there is in order to achieve this type of study and the success of the study lies on a good clinical trial management in which communication and traveling to the centers is crucial.

Hi Fady,

You made a very excellent point because there is definitely a greater chance of data distortion if too many centers are present. Variability needs to be controlled and in order to do so, the scope of the study needs to be clearly defined and those who are conducting the study in the center (operators) need to be trained properly because they are the ones who gather data. A test method that is capable of being conducted in different centers should be created and the operators should be closely monitored in order to reduce variation. However, since repeatability and reproducibility of data is important in a study, companies prefer to have multiple centers because they want to see how different operators handle the study. As Luisa and other students mentioned, the line should be drawn when an appropriate amount of operators at the center are present to properly conduct the study.

Multi-center clinical studies poses significant challenges like communication across multi sites,multiple record keeping methods,clinical access for academic personnel.however the quality of data generated plays an important role in outcome of study.Clinical data management system has become essential to handle huge amount of data.The trail management plan is the key to a successful multi- center studies.It should include an outline of arrangement for running trails,supervision of trails .

Adding to the discussion, the advantages of multi-center trials are numerous:clear results which are more convincing and whose acceptance is higher, . However, multi-center trials require strong efforts for quality assurance concerning admission, treatment and follow-up, thus a highly developed coordinating center is needed.
Also, multi-center trials are considerably more complex than single center trials. They are also very expensive to run both in terms of personnel and resources and therefore require adequate funding form the onset. If a multi-center trial is to be meaningfully interpreted and extrapolated, then the manner in which the protocol is implemented should be clear and similar at all centers.
The number of multi-centers required depends on "What is being studied?", "Has it been tested before?", What tests and procedures are involved?, How long will the study last?, Who will pay for my participation?, How much the total cost for the study?!
Will results of the study be provided to me?

There are many factors to consider when using the multi-center form of clinical study. With this type of study, there could be variations between populations in their genetic makeup, cultural backgrounds, and environmental settings. This could affect comparison of results received from different locations. When doing multi-center trials, it is important to take these factors into consideration when performing the study. It is better to have multi-center trials be done in a common area to keep the differences at a minimum. There is no way to determine exactly how many centers is too much and will decrease variability. The number of centers is based on the study being done and how in depth the results are being analyzed. With more centers, there is more reliability in the results. However, this may result in less number of patients being studied.

I agree with you guys about the facts that there is no specific "good number" in the number of centers, multi-center clinical trials (MCCT) are expensive, there are a lot of aspects involving in MCCT. There is an article named "A guide to organizing a multicenter clinical trial." on PubMed that showed a strategy tackling MCCT. Like many have mentioned, the success of the trial majorly depends on the fluidity of collaboration between all collaborators toward a common goal.
I think the paper mentioned many good points in assuring the fluidity of communication. For example, there are various useful consensus building methods such as focus group discussion, nominal group technique and the Delphi method. These methods will help gather and represent the knowledge and experience of all participants.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917608/

Multi-center clinical trials are the type of clinical trial that my team at work is trying to get approval for. From my understanding there is no "good number" but rather we want as many sites and as many people in the study as possible. Before selecting a location for our clinical trials to take place, there is a tone of paperwork the is signed by both Edwards and the center to ensure that every detail during the study is consistant from center to center. This include but is not limited to; the scans we needed prior to a patients enrollment in the study, detailed medical history of the patients, all the testing the physician must perform on the patients before, after treatment, and at every follow up visit. At every center, there will also be an Edwards clinical specialist and R&D engineer to ensure that the physician and staff are following all the same steps needed and set by Edwards for the clinical trial. I believe that having from one from the company there at all times helps to reduce variability between centers.

I don’t believe there should be a defined limit of center or subjects because that should depend fully on what the study is. However, when choosing multi centers or shouldn’t be random centers that chosen just because they are close to proximity. You want to choose centers who have investigators familiar with the work you are doing for the clinical study and patients that are willing to agree to said study.