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.
One reason that a company may want to outsource their clinical trials is for scalability reasons. With small companies, a limiting factor for clinical trials may be the quantity of patients a company may be able to find. For medical devices which are intended for a rare disease/condition, smaller companies with less experience in screening for suitable populations may struggle, and it could not be financially viable. Outsourcing clinical trials with a company with experience or access to hundreds of patients who fit the inclusion criteria can shave months off of a project. From my understanding, identifying suitable groups for clinical trials can take a long time to generate enough data across different genders, ages, and comorbidities. By not properly identifying the correct populations, it could weaken the clinical trial effectiveness. One additional reason could be for risk. By outsourcing clinical trials, a portion of the risk is assumed by the company conducting the trials. Smaller companies may find a benefit in this, and larger companies may not. Of course, outsourcing for clinical trials is most likely not easy nor cheap (same goes for not outsourcing), so it should be well-evaluated whether a company wants to pursue clinical trials.
Companies often outsource clinical trials not only due to limited internal resources but also to leverage the specialized expertise, infrastructure, and regulatory knowledge that CROs provide. Beyond capacity constraints, outsourcing can enhance credibility by reducing perceived conflicts of interest, as data collected by an independent third party may be viewed as more objective by regulators and the public. While companies can legally conduct their own trials, doing so may raise ethical concerns about data integrity and bias, especially if the outcomes strongly influence market approval. Thus, outsourcing helps ensure compliance, fosters trust, and can expedite trial timelines through established networks and processes.
Companies outsource clinical trials for multiple reasons,
1) Cost reduction: The company does not have the proper infrastructure to conduct the trials independently. The cost of hiring a team of good research scientists would cost tons of money, instead of getting the trial done outside. For most companies, the need for appropriate staffing levels based on the phase of the study, having the required expertise based on the clinical trial region, and cost are the main drivers for outsourcing clinical trial activities.
2) Optimizing Chances of Success: As a small to medium-sized company, funding for clinical trials can be limited. Implementing these clinical study designs may provide cost savings and decrease study timelines.
3) Faster execution: CROs usually have streamlined processes and efficient operations, leading to faster trial initiation and completion.
4) Ethical and scientific implications: It is unethical for a company to conduct its clinical trials and obtain its data.
Small companies do not have enough assets to perform a clinical trial independently. The other factors can be regulatory complexity, diverse patient requirements for global trials, controlling data loss, patient dropout, noncompliance, utilizing better technology, and centralized lab services.
Yes, a conflict of interest develops when the company formulates a product or drug and does its own testing. The trial design may be biased or favored. The negative results may be ignored or delayed. Bias is common if the observer knows the study and control groups. Regulatory agencies: FDA, EMA, Health Canada expect clinical trials to be conducted individualistic way. Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity
Yes, a conflict of interest could be a significant reason for outsourcing. For example, Physicians' economic ties to tobacco, alcohol, baby formula, and pharmaceutical companies have all been criticized as possible nonscientific influences on medical research. Financial interest related to the research means financial interest in the sponsor, product, or service being tested or a competitor of the sponsor, product, or service being tested.
Ref: Evaluation of Conflict of Interest in Economic Analyses of New Drugs Used in Oncology
Through outsourcing clinical trials, Contract Research Organizations (CROs) have been somewhat well-known in the medical device industry helping to reduce expenses, timeframes, and regulatory complexity. Outsourcing can increase production, worldwide reach, and access to specialist knowledge—that which might not be available in-house—with the proper partner.
One of the main advantages is speed; pre-built infrastructure, seasoned personnel, and simplified procedures would help to accelerate trial start-up and implementation usually defining CROs. They also give extensive understanding of legal standards in a variety of fields, which is critical for organizations looking to enter multiple markets. However, maintaining control and quality assurance is a significant challenge. If expectations differ or if communication is poor, trials may suffer from protocol deviations, delays, or data quality issues. Good outsourcing depends on carefully stated agreements, regular meetings, and good relationship between sponsor and CRO.
In what ways may companies ensure alignment and quality while outsourcing clinical research? Should they pay great attention to CRO operations or concentrate more on selecting the suitable partner from start?
