The development of medical devices and drugs is a complex and high-stakes process with many moving parts and various milestones. If you’ve been through it, then you already know that one of the biggest milestones and highest dollar items are clinical trials, which are essential for demonstrating safety and efficacy.
Ensuring a successful clinical trial means proper clinical trial startup, management, and close out. This in turn requires resources that can navigate the various challenges associated with study design, regulatory compliance, patient recruitment, and data management.
In this article, we will discuss the importance of hiring a knowledgeable team for clinical trial management, the key aspects of study management that a Clinical Research Organization (CRO) can help with, and the potential problems you may encounter when inexperienced personnel attempt to manage a clinical trial.
First up: The importance of hiring a team with experience.
As a company, there’s no doubt you’ll invest significant resources into the development of your medical device or drug product with the goal of bringing a safe and effective product to market. The success of your product heavily depends on the proper conduct of bench testing, animal testing, and ultimately clinical testing. Clinical testing is often the biggest contributor to the safety and efficacy data of a submission. Having a team that knows the ropes is not only smart, it’s absolutely necessary.
You see, a knowledgeable team can ensure that the clinical trial is designed and executed according to regulatory guidelines and industry best practices all while maintaining patient safety and data integrity. Well managed trials often undergo a smoother approval process, have reduced risk of study delays or failures, and have faster times to market for the product. Furthermore, a knowledgeable team can help you mitigate potential financial risks associated with failed trials and protect your company's reputation and credibility within the industry.
There is also the consideration of resources. Hiring and maintaining a team of trained professionals can incur significant costs. Moreover, it’s not only hiring for the experience that’s obvious, but it is often the need for collective experience when something goes wrong… and it will. When things go wrong, you will likely need experience that you may not have planned for. This means it’s important to interview a company's problem-solving skills.
Finally the team should be a good cultural fit. Don’t just look at how many studies a CRO claims to have done. CROs usually acquire their experience in ways you may not appreciate, such as through acquisition. As one CRO merges or acquires another then they have also bought the rights to say how many studies the previous organization performed. In this instance, a CRO may say that they have worked on hundreds of oncology studies in the past, but the collective organization may not have done ANY studies. Moreover, experience can be fleeting as people move from organization to organization. It is best to have both experience and skills, just don’t fall into the trap of placing too much value on previous experience. This is called experience bias. It’s a common bias we all are subject to every day. It can be tricky so look out for it.
So, what are some key aspects of clinical trial management that you should know?
A Clinical Research Organization (CRO) can provide expert guidance in navigating the key aspects of clinical trial management.
These aspects include:
Study Design: A robust study design is necessary for generating reliable and meaningful data. CROs work closely with sponsor companies to develop a study design that considers the objectives, endpoints, and statistical analysis plans, ensuring that the trial has the potential to yield valuable insights that ultimately support regulatory approval. Additionally, well-designed studies can minimize the number of required participants, thereby reducing costs and ensuring a more efficient trial.
Regulatory Compliance: Clinical trials must adhere to local and international regulatory requirements, such as those set by the regulatory agencies like the FDA and be conducted under Good Clinical Practices (GCP) in the US or an equivalent. Good Clinical Practice is not necessarily a set of rules and regulations spelled out exactly for someone to follow, but rather aspirational goals guiding the conduct. The best practices have been developed over years of practice and are often not necessarily obvious to people that have never worked in the industry. CROs ensure compliance with these guidelines and help to prepare and submit the necessary documentation to secure approvals and maintain compliance throughout the study. By maintaining compliance, your company can avoid costly delays or termination of the trial due to regulatory violations. Furthermore, a CRO's familiarity with regulatory requirements allows them to anticipate potential issues, providing proactive solutions to ensure a smooth clinical trial process.
Patient Recruitment and Retention: The success of a clinical trial depends on the ability to find and retain suitable patients. CROs develop strategies to identify and engage the right patients for the study, reducing the risk of high dropout rates that can jeopardize the trial's success. Effective patient recruitment strategies may include targeted advertising, partnerships with medical professionals, and the use of specialized patient databases. Moreover, CROs can help develop and implement retention strategies, such as regular follow-ups, patient education, and providing support services, to minimize dropout rates and ensure enough participants complete the trial.
Data Management and Quality Control: CROs manage data collection, storage, and analysis, ensuring data integrity and minimizing the risk of errors that can lead to regulatory scrutiny or rejection. This involves implementing quality control measures and using standardized data management practices to guarantee the reliability of the data generated during the trial. Proper data management allows companies to draw accurate conclusions from the trial, supporting regulatory submissions, and informing future product development efforts. Additionally, secure and efficient data storage practices protect patient privacy and maintain compliance with data protection regulations.
The problem with inexperienced teams managing clinical trial.
By now, you’ve likely caught on to the emphasis placed on the word “experienced” when it comes to assembling a team for your trials. If not, let us drive it home. When inexperienced personnel attempt to manage a clinical trial, several issues can arise, leading to delays or failures in the study. These issues are typically related to poor study design, regulatory violations, inefficient patient recruitment and retention, and compromised data integrity. Other times, it’s just a matter of not being familiar with the process.
Here are 5 challenges we’ve seen inexperienced companies run into:
1. Underestimating Internal Resources: Companies often fail to fully recognize the extensive internal resources required to successfully conduct a clinical trial, leading to unanticipated setbacks.
2. Regulatory violations: A lack of familiarity with regulatory requirements can lead to non-compliance, potentially resulting in fines, delays, or termination of the trial. These consequences can damage a company's reputation, reduce investor confidence, and hinder future product development. Furthermore, regulatory violations can lead to increased scrutiny from regulatory bodies, which may result in more stringent requirements for future trials.
3. Inability to Solve Problems: When faced with challenges such as recruiting suitable participants, managing difficult trial sites, maintaining transparent data reporting, or dealing with deviation creep, inexperienced teams may struggle to find effective solutions.
4. Failure to Anticipate Issues: Inexperienced management often fails to foresee potential problems until they are already in the middle of the trial. Needless to say, this lack of foresight can have a negative impact on the trial's progress.
5. Resource Exhaustion: In their attempts to address the aforementioned challenges, inexperienced teams may deplete their resources, both in terms of finances and personnel. This can have detrimental effects on the trial and strain the overall financial health of the sponsor company.
So to put it all together, what does this mean?
Basically, hiring a knowledgeable team to perform study management is vital for the successful development of medical devices and drugs. This is where an experienced CRO comes into play. We understand the importance of putting you, the client, right at the heart of our mission for your ultimate success. Our commitment to accountability, unity, and excellence is what drives our ability to provide the support you need throughout the entire clinical trial process. You should be able to expect to benefit from a smoother approval process, reduced risk of study delays or failures, a faster time to market for the product, mitigated financial risk associated with failed trials, and protection for the sponsor company's reputation and credibility within the industry. On the flip side, you’re looking at potential problems that can arise from inexperienced management, such as poor study design, regulatory violations, mismanagement of resources, and poor team cohesion, all of which can lead to significant financial losses and delays in product development.
So, the bottom line is when assessing whether to go it alone or work with a partner, make sure to interview appropriately, place the appropriate weight on experience and culture, and estimate your resources appropriately.
