Clinical trials are a costly business, but with trial quality being so critical to patient safety and data integrity, getting it right is key. So much of that comes at the planning stage.
There are a few common mistakes that researchers, Contract Research Organisations (CROs), and sponsors may make when planning a clinical trial. It’s essential to carefully consider and overcome these obstacles to ensure the trial’s success and the generation of reliable and meaningful results.
Here are 12 common mistakes you can make when planning a clinical trial:
1. Inadequate Study Design
Failing to carefully design the study can lead to biased results or an inability to evaluate the objectives effectively. Common issues include inappropriate sample size, flawed randomisation, or the lack of a control group.
2. Poorly Defined Endpoints
Unclear or inappropriate primary and secondary endpoints can undermine the trial’s ability to measure the desired outcomes accurately. It’s crucial to clearly define and justify the chosen endpoints. Similarly, ensuring robust inclusion and exclusion criteria can have a huge impact on trial success and requires careful consideration.
3. Inadequate Patient Recruitment and Retention
Failing to recruit a sufficient number of participants or losing them during the trial can compromise statistical power and affect the trial’s validity. Understanding the target population and implementing effective recruitment and retention strategies is vital.
MAC Clinical Research (MAC) is an expert in patient recruitment and retention. Our bespoke recruitment engagement software suite, MAC EnVision®, takes a science-based approach with a purpose-built innovative software solution and an in-house team of specialists to find volunteers and patients with accuracy and precision. This participant-centric model follows participants throughout their full clinical trial experience, including expertly pre-screening participants effectively according to the study’s inclusion and exclusion criteria.
MAC EnVision® provides valuable insight into the participant’s journey. This insight forms the basis of our strategic and successful study planning, including the implementation of recruitment and retention strategies.
4. Lack of Protocol Adherence
Deviating from the established study protocol can introduce bias and affect the reliability of the results. It is important to ensure that all study personnel adhere strictly to the protocol throughout the trial.
5. Insufficient Statistical Planning
Inadequate consideration of statistical methods and analysis can result in data that is difficult to interpret or lacks statistical power. From the very beginning of a study, MAC’s statistics team can support the development of the clinical research protocol by choosing primary outcomes and proposing a study design with the appropriate sample size. Their role is crucial to study randomisation and supporting regulatory submissions.
Later in the study, they’ll also collaborate with our statistical programming team to carry out the statistical analyses, interpret the results, and safeguard the integrity and validity of the study.
6. Ethical Concerns and Regulatory Compliance
Failure to adhere to ethical guidelines or regulatory requirements can lead to serious consequences, including delays in regulatory approvals , non-approvals and non-acceptance from regulatory authorities, study suspension or even withdrawal. Proper ethical review board approvals and compliance with regulatory standards are crucial.
7. Inadequate Monitoring and Quality Control
Regular and thorough monitoring is essential to ensuring data integrity and participant safety. Lack of monitoring can lead to undetected errors or misconduct, jeopardising the trial’s validity.
8. Not contracting the right sites
Most clinical trials are run at clinical research units; process, quality, and infrastructure can all play a part in the execution of the trial on site. It is critical that the right sites for the right studies are selected. As a CRO, MAC can run trials at any site globally. We also own a network of sites, and for this reason, we are optimally placed to support any site with their work; we understand the challenges faced and have tried and tested strategies to mitigate risk.
9. Inadequate Budget and Resource Planning
Underestimating the financial and personnel resources needed for a trial can result in delays, premature termination, or compromised data quality. Adequate budgeting and resource allocation are vital.
10. Ineffective Communication
Poor communication among study personnel, investigators, and sponsors can lead to misunderstandings, delays, and errors. Establishing clear communication channels and maintaining regular updates is essential.
11. Failure to Consider Real-World Factors
Ignoring practical challenges such as patient compliance, variations in clinical practice, and logistical issues can impact the trial’s feasibility and applicability to real-world scenarios.
12. Not selecting the right CRO
A good CRO can help with some of the above, but a great CRO can help with it all and ensure planning is seamless and robust, avoiding mistakes and reducing risk. We recently wrote about the importance of selecting the right CRO.
Addressing these potential pitfalls during the planning phase will increase the likelihood of a successful and scientifically sound clinical trial. Engaging a multidisciplinary team and seeking input from experienced professionals in clinical research will both contribute to more robust trial planning and execution.
At MAC, we see our relationship with our sponsors, whether they’re small biotech or large pharma, as consultative and supportive. Early engagement can mitigate many of the common risks discussed above. Read about our strategic consulting services to find out more.
