Clinical trials are projects to provide relevant data to show the safety and efficacy of a Class I or Class III device. They're necessary for these devices to be on the market. What are the most prevalent reasons that a company might want to outsource these clinical trials? If the company itself performs them, the company would have control over the schedule and generally have an easier time monitoring and controlling the trials. I can understand that some companies are small and do not have the assets to perform their own clinical trials, but are there any other reasons as to why a clinical trial would need to be outsourced? Could conflict of interest be a reason for outsourcing? The company wants their product to be on the market, so would it be unethical of them to conduct their own clinical trials and obtain their own data? I would appreciate others' thoughts on the matter.
Whenever I am thinking about how a clinical trial would be carried out, I try to remind myself that one would effectively need an entire clinical institution to do so. For example, there are definitely some smaller companies that are capable of running their own clinical trials because they have the proper medical personnel in-house to carry out the trial. Even if there is a huge company with enough money to basically own a hospital, if they don't have orthopedic surgeons to monitor the efficacy of a bone repair scaffold in patients, they would still need to outsource the work.
In regards to your other point about the ethics of holding a clinical trial in-house, we should remember that any clinical trial would need to be approved by the FDA and an IRB. So, even though there might be the worry of introducing bias, these protocols are thoroughly vetted and they often incorporate double-blinded placebo studies to reduce this bias as well. However, on this note, it could be argued that outsourcing clinical trials may be a more ethical way of carrying out these studies in an industry setting.
I agree with your point about the importance of having adequate medical personnel and facilities to conduct trials effectively, which can be difficult for some companies to manage in-house.
In addition to potential size and resource constraints, another common reason a company may want to outsource clinical trials is to benefit from the specialized expertise of a contract research organization (CRO). These organizations have prior experience navigating the complex regulatory environment and managing the logistical challenges associated with clinical trials. Outsourcing can result in more efficient and streamlined trials, particularly for companies with limited experience in this field.
In terms of ethics, while internal trials must be FDA and IRB approved, outsourcing can help to reduce any perceived or actual conflicts of interest. Having an independent party conduct the trials can help ensure the data's objectivity and credibility, thereby increasing trust in the results.
Outsourcing could provide the expertise and experiences needed for a company to conduct their clinical trial but it does not eliminate conflict of interest. They may have financial incentives to the success of the trial and the approval of that device which could influence how they conduct that test. These trials could be conducted impartially and without integrity if the outcome of the trial is dependent on the outsourced company. Thus, sourcing for a reputable company with a good record of ethical conduct and transparency is necessary to ensure that the clinical trial is done properly.
At the end, the decision to outsource clinical trials depends on various factors, such as the company's resources, expertise, timeline, and strategic goals.
I believe that if a company has the resources (employees, labs, schedule, timing, money) available to conduct the clinical trials in house, they would certainly do so. Outsourcing these clinical trials to third party companies that specialize in performing trials and keeping documentation according to GDP is a great option for companies that have projects and ideas but don't have the resources to conduct the training. Some larger, well established companies that have been around for longer can also opt to go with outsourcing the trials because they can afford to and have worked with the same vendors to outsource to for many years. As others have mentioned, clinical trials could require approval and regulations and the third party companies that only focus on performing these trials could also have a more automated process of getting the regulations and approvals because that is their area of expertise.
