5 steps to ensure a successful clinical trial

Nicola Pearson Date published: Apr 03, 23

Clinical trials are vital to helping developers deliver products that are safe, meet the needs of potential patients, and get drugs to market as quickly as possible. But factors like patient recruitment and retention or securing a site location can delay the proposed timeline and hinder a trial’s success. 

The development stage of any new drug will see challenges that form pivotal moments in whether it reaches needy patients as quickly as possible. But putting steps in place to master the clinical trial basics every time can ensure these potential stumbling blocks don’t become insurmountable obstacles.

How to ensure a successful clinical trial

The following guidelines will help developers ensure they have the foundations in place to deliver successful clinical trials:

Effective patient recruitment and retention

A clinical trial can only be as good as the patients it recruits to test the drugs being developed. Developers typically have a vast pool of willing participants, given recruitment firm Accelerated Enrollment Solutions alone has a database containing more than 100 million patients, 160 global research sites, and 700 investigators.

However, it’s vital to select patients that match the drug’s required target population, including appropriate ethnic and racial groups. Developers can improve patient recruitment and prevent dropouts by regularly assessing contract research organisations’ (CROs) retaining methods.

Retention is also bolstered by holding clinical trials in site locations convenient to participants and where patients are treated well or with compassion by staff. This again falls back on working with the right CROs to save time and resources.

Smarter clinical trial methodologies

Many pharmaceutical companies deploy ineffective processes to manage and predict clinical trial costs. For example, spreadsheet-based models rely heavily on human input and struggle to capture or predict variables compared to forecasting solutions powered by artificial intelligence (AI) and machine learning-powered technologies.

These capabilities improve accuracy, increase visibility, and account for multiple variables in real-time, helping firms generate better-informed forecasts. AI-based forecasting also simplifies scenario planning, improves enrolment risk prediction, and improves access to real-time data to inform firms’ decision-making processes. As a result, companies’ patient recruitment and site selection are more accurate, and they’ll enjoy significant time and resource savings.

A standardised process for document reviews

Another critical but often overlooked step in delivering smooth and successful clinical trials is having a tool in place to support a standard process for document reviews.

As discussed in our recent webinar, many medical organisations struggle with their medical writing review and documentation processes due to a lack of standardised methods and tools. As a result, they miss critical deadlines and suffer issues like document deduplication, collaborators’ insights being overlooked or deleted, and a lack of accuracy and consistency in documents.

A standardised process, through a tool like Ideagen PleaseReview, helps to speed up and simplify medical writing and reviews. It guarantees higher-quality documents delivered in shorter timescales, time and cost savings, and allows medical firms to comply with increasingly stringent industry regulations and standards.

Harness real-world evidence

The United States Food and Drug Administration (FDA) uses real-world evidence (RWE) to inform regulation, monitor drug safety, develop guidelines, and enhance clinical decisions. But drug developers can also use RWE to inform the design of clinical trials and observational studies. This approach significantly benefits developing more innovative products and devising unique treatments.

Crucially, RWE enables a more patient-centric approach to clinical trials, which mitigates the risk of drug development delays and increases the chances of product success. Again, access to the right technology is vital, so companies need to look to tools that enable and simplify digitisation, virtualisation, and data collection and analysis.

A smarter approach can help firms design clinical trials based on patient preferences, help them better understand patient needs, and devise endpoints based on patient insights. All of this is crucial to recruiting suitable patients, improving the outcome of clinical trials, and ensuring better-informed treatments.

Find the right project approach

Many clinical trials fall short because firms don’t have the right approach to resources, be it over-relying on in-house talent or placing too much focus on outsourcing. A strategic approach to outsourcing will enhance a trial’s efficiency, quality, and operational success. 

However, coordinating the appropriate level of in-house and outsourced resources to meet project goals is often challenging. Companies can overcome this by working with a functional service provider, which can customise engagements to companies’ specific requirements and offer a pool of leading talent.

Deliver more successful clinical trials

Establishing a solid approach to clinical trials based on standardized processes and tools can help drug developers ensure every trial delivers on its targets. Tests must target the right patients using suitable methodologies and utilising data as effectively as possible.

While the success of clinical trials is underpinned by mastering the administrative basics. For example, Ideagen PleaseReview helps medical organizations write and review higher-quality documents in less time and at lower costs.

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