Clinical trials are not cheap to conduct, and with data integrity and patient safety being so critical, it is essential to get everything right. The key to success can be found in the study planning.
It might be surprising to learn that there are several common traps that Sponsors and Contract Research Organisations (CROs) frequently fall into when planning clinical trials. We list a few of the more obvious (and ones we have frequently encountered at Niche) oversights here to help you ensure your trial’s success and that you generation a reliable and meaningful data set.
It might seem obvious but, failing to take appropriate care when design your study will lead to confounding observations or possibly the inability to meet your objectives. Issues that frequently are not given due consideration include sample size, inappropriate randomisation, and the failure to address the necessity (or not) of a control group.
Failing to clearly define the primary and secondary endpoints will undermine your trial’s ability to meet its desired outcomes precisely. You must clearly define your endpoints and be able to justify their selection. Equally, selecting robust inclusion and exclusion criteria will have a marked impact on your success – even in healthy volunteer studies your inclusion/exclusion criteria require careful consideration.
Sponsors often see the early stages of clinical development as a ‘slam-dunk.’ Having little concern over the ability of the Phase I unit to recruit and/or retain sufficient particiapants for their study. However, complex and/or unpleasant procedures can deter participation. It is essential to give consideration to your target population in your study protocol and implement effective recruitment and retention strategies. Failing to recruit sufficient subject numbers or losing them during the trial will either compromise statistical power and affect the trial’s validity (if you cannot replace them) or increase the study cost and delivery time (if you do decide to replace them).
Consideration needs to be given to the deliverability of the protocol for the site staff. Deviating from the established study protocol has the potential to introduce bias and impact on the integrity of the data. It is important to ensure that the study procedures can be delivered by all study personnel throughout the trial.
Failure to due consideration to statistical methods necessary meet the study objectives and the data analysis has the potential to confound the study data making it difficult to interpret or failure to achieve its planned statistical outcomes. Your statistical team must support development of the clinical research protocol by selecting appropriate primary outcomes and proposing a study design with the appropriate sample size.
The role of the statistician is central to study nailing the randomisation and supporting regulatory submissions. Later in the study, the statistician will consider the study conduct within the statistical analyses, contribute to the study data interpretations, and oversee the integrity and validity of the study.
Failure to consider the necessary ethical or regulatory requirements has potential to delay the regulatory approval of your study. You could face delays in regulatory approval, non-acceptance from regulatory bodies, suspension of the study or even withdrawal. The secret to success in your ethical and regulatory authority submissions is taking care to comply with all required standards in your protocol from the outset.
Establishing an appropriate monitoring schedule that addresses both the data density and patient numbers and performing thorough monitoring conducted under a maintained Quality Management System is essential to ensuring data integrity and participant safety.
At Niche we encourage our Sponsors to consider including visit redundancy into the monitoring plan so that emerging issue can be addressed promptly and minimising the potential for undetected errors or misconduct.
Most early phase clinicals studies are conducted at clinical research units. Not all Phase I units are created equal: process, quality, and infrastructure all play a part in trial execution. It is crucial that you select the right site for the study you are planning. Certain CROs have differentiating specialities and experience that can identify them as ideal for your project. In addition. Certain sites have similarities that single them out as ideal for networking if you need to combine resources to facilitate timely delivery. At Niche we have close relationships with all the UK Phase I sites. We can advise on which sites are optimally placed to support any your work; we understand the challenges you face.
Many early Phase projects that we work on at Niche are conducted by biotechs and/or established pharmaceutical companies where, for different reasons, the focus is on negotiating and maintaining constrained budgets. However, underestimating the financial and personnel resources needed for a trial can result in delays, compromised data quality and potentially premature termination. We advocate adaptive budgeting to address resource challenges.
Establishing clear communication channels and maintaining regular updates between study personnel, investigators, and sponsors is essential to successful study conduct. Failure to set up a culture of open communication will see errors that can lead to misunderstandings, delays, and error.
Addressing these common pitfalls during the planning phase will increase the likelihood of you conducting a successful, scientifically sound and stress-free clinical trial. The secret is in understanding the risk of not considering these challenges when preparing your protocol. The process can be facilitated by creating a concept or synoptic protocol to serve as a stalking horse for the wider project team (see our Insider’s Insight on concept protocols [1]).
A good CRO can help with some of the above, a great CRO will guide the project team with seamless and robust planning. The greatest benefits can be derived by engaging a multidisciplinary team with experienced clinical professionals both in robust trial planning and execution. 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.
At Niche we are ready to help.
References
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