What is the expertise required for the management and conduct of clinical trials?
Performing a clinical trial can be the most exhausting part of developing a new medical device but is also the most important portion of the process for presenting a new technology on market today. In addition, a clinical study also can be the gateway to a discuss about cost coverage and reimbursement for your device.
In other words, a good quality performance of risk analysis is indispensable to your product’s development plan, and that’s why the management of clinical studies must be done in a most precise and regulatory-accordance manner.
This article will discuss particularities of clinical trials design and management to ensure the success of your device. Keep reading!
What are the key considerations in designing clinical trials?
After developing a new technology, your medical device or product is often requested to have their performance, safety and claims analysed. The process in which those questions will be answered is called clinical trial or clinical study.
A clinical trial can be a time and money consuming procedure, so is important to not only understand the steps and requirements, but also count on experienced professionals’ help for completing the studies requested by the regulation organs of the targeted market country(ies) and raising additional funds through investors.
The first step in designing clinical trials is getting to know if your device needs to present one. Sometimes, when the manufacturer is able to show that relevant risks can be mitigated, the trial is not a regulatory obligation to obtain market approval.
What are the factors to consider when managing larger clinical trials that require additional assistance?
The clinical trial process may be a winding road for the manufacturer institute to navigate alone. More often than not, regulatory affairs are different in each country, so partnering up with professionals that have the proper knowledge can make the process faster and error-free, therefore hiring a Contract Research Organization may be your best option, not only economically speaking, but mostly for the expertise CRO teams can offer.
For that reason, a search for the best fitting CRO company must consider the targeted market and the needs of your medical device, regarding their therapeutic claims and potential risks.
What are the strategies for effectively organizing and managing the individual tasks involved in a clinical trial?
Decisions will be made for the entirety of the study process, and for that the team must consider many different variables according to what the analysis shall prove (or disprove).
For example, calculating the number of patients needed to enrol and knowing how to retain them throughout the follow-up period, or even determining what type of clinical trial should be conducted in the first place, is important to the overall success of the procedure
Once more, having an experienced team besides your own will make those decisions being the right ones and the management of the tasks will be more productive and effective.
Management tools
A clinical trial can count on the help of a few management tools to make the work as precise as it must be. Some of those tools are:
Clinical Events Committee (CEC)
CEC is a group of physicians that follow the trial and have the role to decide whether or not individual serious adverse events are relates to the device under study. Those physicians must not be connected to the manufacturer in any way.
Core Laboratory
A central laboratory set up is able to provide analysis of specific results with consistency for a more complex clinical trial. Imaging, measurements and analysis of all clinical specimens are some of the materials a core laboratory can offer to the study.
What is the role and significance of a Data Safety Monitoring Board (DSMB) in clinical trials?
As a Clinical Research Organization (CRO), understanding the role and significance of a Data Safety Monitoring Board (DSMB) is crucial. The DSMB plays a vital role in ensuring the safety of participants and the integrity of the trial.
The primary role of a DSMB is to independently monitor and review the accumulating data from a clinical trial. Its main responsibility is to safeguard the rights, welfare, and safety of study participants. The DSMB achieves this by assessing the ongoing safety data, efficacy outcomes, and overall study progress.
The significance of a DSMB lies in its impartial and expert evaluation of trial data. By conducting regular reviews, the DSMB can identify any potential safety concerns or treatment benefits early on. This helps maintain the scientific validity and ethical integrity of the trial.
Specifically, the DSMB performs the following key functions:
- Data monitoring: The DSMB reviews the interim and final data collected during the trial to ensure the safety of participants and evaluate the efficacy of the intervention.
- Safety oversight: It closely monitors adverse events, serious adverse events, and any other safety-related concerns that may arise during the trial. If necessary, the DSMB can recommend modifications to the trial design or even early termination based on safety considerations.
- Unblinded analyses: In some cases, the DSMB may perform unblinded analyses to assess treatment effects and make informed decisions regarding the continuation, modification, or termination of the trial.
- Recommendations and reporting: The DSMB provides recommendations to the sponsor or trial steering committee based on their evaluations. These recommendations help guide the trial’s progression and ensure the highest level of participant safety.
In summary, the DSMB is a critical component of clinical trials conducted by CROs. Its role in monitoring data, ensuring participant safety, and providing independent assessments greatly enhances the reliability and credibility of the trial results.
What are some valuable tips for effectively running a successful clinical trial?
Choose a CRO with medical device expertise to head the operation. The ideal CRO is capable to demonstrate success in running clinical trials in your product’s field.
Guarantee integration between your team and the CRO professionals, as they will need your guidance, feedback and support.
Maintain an open communication with prospective vendors as early as possible at the beginning of the trial process.
Understand the importance of a clear communication in collaborative partnerships. You should be direct in expressing your project needs and how much you can afford.
ECLEVAR
ECLEVAR MEDTECH is a unique CRO, that brings competent authority, notified body and expertise together to complete your clinical evaluation (CER), clinical trials and regulatory challenges from pre-market to post-market follow-up.
