Evolution of Clinical Trials: Address the Challenges of the Future

The first modern randomized controlled trial took place in 1948 testing streptomycin for pulmonary tuberculosis. Since then, clinical research trials have significantly evolved in terms of their impact on regulation and scientific and statistical foundation. Important developments over the last decade came with the Clinical Trials Transformation Initiative (CTTI). The CTTI addressed and proposed solutions for a range of operational and scientific trial-related issues.

Clinical trials are still evolving and the need to address challenges continues. Here we’re sharing a few key challenges facing the clinical trial community with proposed clinical development solutions to make trials more relevant, feasible, and credible.

Globalization of Clinical Research Trials

Most of the 20^th century featured disjointed and compartmentalized clinical trials from around the world. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brought a successful new approach. Today, most trials become global trials by necessity.

Even though global trials increase the efficiency of drug clinical development, they bring three main challenges:

1. Participating regions may request predefined numbers of patients from their area or health care environment to be included.
2. Regulators of various regions often have different requirements making it difficult to develop a single, globally-acceptable trial protocol.
3. Detailed national regulatory frameworks or ethical requirements regarding the conduct and approval of trials increase operational complexity across several regions.

To address these issues, a multi-pronged approach is needed:

1. Regulators must be willing to work together to synchronize requirements.
2. Innovative methodology is critical for preplanned extrapolation of clinical research results. Samples sizes should be within a manageable size while satisfying regional regulatory requirements.

The Complex Operation and Expense of Trials

The expense and operational complexities of running a clinical trial have increased over the last decades and continue to rise. This is often due to needing intensive monitoring, reporting rules, and governance.

As the complexity and cost increases, the efficiency of gleaning clinical knowledge decreases and can negatively impact patients. The nature of performance metrics needs to align better with the overall objectives of medicine development rather than simply the delivery of the different parts of the trial process. There’s a need to reconsider what makes a trial relevant and adopt a risk proportionate approach to trial design and management from the start.

CTTI and ICH are working to make clinical research trials more efficient and responsible for clarifying the roles and responsibilities of parties conducting trials.

Transparency of Clinical Trials

Much debate has taken place in the last decade regarding public availability of clinical research data from completed trials. Most believe the data and results should be rightfully shared with participants.

This shift and increase in transparency could improve the usefulness of future trial outcomes and increase efficiency. Soon, patient-level data from completed clinical trials could become available to researchers which could change how clinical trials are conducted.

Several bottlenecks in achieving transparency remain unresolved. However, the sooner issues slowing data sharing and secondary analysis are resolved, the sooner we can move from stand-alone to best-utilized clinical trials.

Transparency also benefits patients and the public. By making information available, it builds trust. In addition, it empowers individuals to learn about trials for which they may be eligible and become better informed to support their own health care choices.

At Pharmaron, we offer a comprehensive clinical research center to support clinical trials. Contact us to learn more today.