According to Johns Hopkins Bloomberg School of Public Health, clinical medical intervention trials that companies use to support FDA drug approvals cost approximately $19 million per trial. While this may only be one percent of the total cost of developing a new drug or other medical intervention, it means creating a low-quality clinical trial — or getting low-quality data from the endeavor — can be very costly. It's important to consider quality at every stage of the clinical study, from initial design to continual data checks and final analyses. This article will explore what quality means in a clinical trial setting and how to ensure quality throughout the project. That begins with understanding the nature of clinical trial strategy.
What Is Clinical Trial Strategy?
The National Institute of Health defines a clinical trial as:
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
A clinical trial strategy is the overall methodology and approach that is designed to ensure the trial is successful. Creating a proper strategy before the trial begins allows teams to be more cost-effective, robustly document evidence of the product's effects or value, and better meet the FDA and other regulatory bodies’ requirements. Clinical trial strategies include the following elements:
- Determining the reviewer's standards for high-quality trial practices
- Establishing a trial process that has the most likelihood of substantiating the product’s (i) effectiveness in its primary purpose and (ii) safety
- Following protocols for regulatory compliance
- Identifying ideal clinical conditions
By considering the prerequisites, process particulars, and expected outcomes of the trial, you can better manage each stage of the trial and ensure high-quality results.
However, the term "quality" can be subjective. Before you begin designing your strategy, it's important for all members of the clinical trial team to have the same understanding of quality.
What Is "Quality" in Clinical Trials?
In order to meet regulatory standards, clinical trials have to be high-quality. This means adherence to your company's policies, adherence to the reviewer's quality expectations, and compliance with applicable regulations.
It can seem impossible to predict the subjective factors that color others' ideas of "quality," which focus on a wide range of objectives such as adherence to trial norms, efficacy of the results, minimization of liability, or smooth approval processes resulting from the study. That’s why it is essential to follow standards and regulations.
Beyond regulatory compliance, there are two key areas of the trial that cover most objective and subjective standards of quality: within-study quality and quality of results.
One quality-centric aspect is to focus solely on the procedures of the trial itself. Did all participants properly conduct the trial within their roles? Are the results unbiased? Did the trial as a whole comply with the standard operating procedures outlined in the clinical trial strategy? Most importantly, did it comply with all applicable regulations?
Quality of Results
The quality of results examines whether the results genuinely demonstrate the efficacy and safety of the product. In other words, would regulatory bodies accept the trial results as evidence that the product works?
If a product does not function as intended, then no amount of within-study quality will lead to high quality of results.
It's essential to focus on both quality aspects while undertaking the trial project. A high degree of within-study quality doesn't guarantee a high quality of results, and high-quality results can't be trusted without excellent adherence to within-study quality.
How to Ensure Quality in Your Clinical Trials
Creating a robust clinical trial strategy that lays out the trial protocols, accounts for potential biases, and complies with regulatory requirements is the only way to proactively maintain the quality of clinical trials. You must follow the below requirements as you create your strategy:
Identify the Clinical Conditions
Narrow the lens of your trial's focus to specific clinical conditions. Determine (i) what the condition(s) is/are, (ii) what effect the trial intervention should have on the condition, and (iii) to what degree the effect should take place to be considered successful. Clearly outline this in all clinical trial documents and remain consistent throughout the approval process.
Use the Right Clinical Trial Design
In the broad arm of clinical research that goes into medical intervention and drug development, regulatory bodies establish different phases of clinical trials. For example, the FDA has established four main phases of clinical trial progression:
- Phase I: These trials help determine the medical intervention's safety, proper dosage, and potential side effects.
- Phase II: These larger trials further test an intervention's safety and effectiveness.
- Phase III: These trials continue the examination of the intervention's effectiveness and safety. They simultaneously compare the tested intervention against common treatments.
- Phase IV: Phase IV studies are only conducted after the FDA approves the medical intervention.
Clinical tests must be matched with the best format for each phase. Determine if your chosen clinical partners have the right skills and experience to conduct a particular trial type. This supports within-study quality.
Use Peer Review of Protocol
Peer reviewed protocols establish some degree of quality control beyond clinical trial design strategies. Third-party professionals can test, investigate, and critique a medical trial's protocols to find potential errors or make claims more robust through further study. This supports within-study quality and the quality of results.
Routinely Check the Data
Reviewing the data throughout the course of the trial is necessary for ensuring high-quality results. This step includes the following checks:
- Ensure the raw data is robust and error-free enough for statistical analysis.
- Look for deviations in the data. If deviations or discrepancies exist, look for the underlying cause and correct for it or understand the nature of it. Discrepancies may happen, but they must be clearly documented and evaluated.
- Determine the markers of what is considered sufficient clinical evidence of safety and effectiveness. Measure the existing data against these standards to ensure the trial is progressing smoothly, and you're receiving enough evidence.
Monitoring the trial through a data-based lens allows your team to monitor the quality and success of a trial. Progress checks let you evaluate if the trial needs to be restarted, halted, or modified.
Make Quality Your Top Priority During Clinical Trial Design
Designing your clinical trial thoughtfully will make the difference between high-quality, trustworthy results and failure. Start by designing your clinical trial strategy with a focus on:
- How you will ensure within-study quality
- How you will set the best conditions for a high quality of results
Proactively focusing on these two elements will minimize the risk of needing to repeat trials, which will lower the cost of the project and make your medical intervention's effectiveness more clear to peers and regulatory bodies.
Creating a high-quality clinical trial strategy requires experience and skill. However, hiring a full-time strategist is not always the best choice economically. Medpoint’s network of over 200 technical advisors includes experts in all aspects of clinical trial strategy. To find the right expert for your needs, contact Medpoint today.