Inefficiencies of Clinical Trials

Clinical trials are the cornerstone of innovation and medical research, helping to evaluate the safety and efficacy of new treatment options, drugs and medical devices. These trials not only drive scientific progress but help with groundbreaking therapies that could potentially improve patient outcomes and quality of life. Despite the crucial role, they are often hindered by inefficiencies including high cost, lengthy timeline, and patient recruitment and retention. These barriers can hinder progress in an unmet patient population with limited access to innovative treatments. Furthermore, regulatory complexities, ethical considerations, and disparities in trial participation add to the challenges of clinical trials. 

Recruitment and Retention Challenges 

One of the most significant obstacles of clinical trials is the issue of participant recruitment and retention. The process of enrolling in clinical trials is not straightforward; it requires finding a participant who meets the specific criteria for a study which can be time-consuming and expensive. Many trials face delays or even cancellations due to insufficient enrollment because of these requirements. Up to 80% of clinical trials fail to meet their recruitment timelines which leads to an extended duration and increased cost. This could be from underperforming research sites, high dropout rates and unqualified referrals. On average, 25-26% of participants drop out after giving consent which could compromise the statistical power of the study and lead to biased results.  

To address recruitment and retention challenges, researchers and sponsors are leveraging social, medical, and digital platforms for targeted recruitment. They are also implementing patient-centric trial designs to reduce burden and utilizing mobile health technology to minimize transportation needs.  Furthermore, improving communication with participants, as well as providing continuous support throughout the trial can enhance retention rate. Many of these trials can be on mentally, emotionally and physically taxing on both the patient and the family as well. Studies have shown that personalizing patient engagement strategies, like frequent follow-ups and educational resources has significantly improved patient adherence towards the trials. 

Data Management and Quality Issues 

Another obstacle faced in clinical trials is data management and quality. Traditional paper-based methods of data collection are prone to error, time-consuming and are difficult to analyze. Even with enhanced technology like electronic data capture systems, many problems still persist with data integrity, standardized operations and the use of different platforms. These challenges can also lead to a delay in data analysis, high cost for data cleaning and verifications, and could compromise the reliability of study results. 

To help with these obstacles, many are using artificial intelligence (AI) and machine learning (ML) algorithms to help improve data quality check, detect trends and outliers, and overall streamline the data analysis process. These implementations help standardize data collection and promote interoperability between different electronic systems used at different research institutions. 

Regulatory Complexities 

The regulatory body surrounding clinical trials also contribute to the inefficiencies of them. While regulations, that are created by the FDA and other regulatory bodies, are important to help ensure patient safety and efficacy of the drug, the complex and varying requirements across different regions of the world lead to delay and increased costs. For example, if the majority of patients are in two different regions of the world, like the US and South Africa, this would require different trial protocols and submissions to different health authorities. This may not only be time consuming but add variability to the trial itself. 

To help solve these regulatory complexities, there is movement for harmonization of clinical trial regulations across different regions. For example, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) goal is to help streamline regulatory processes and help reduce unnecessary cost and time. If duplicative efforts could be reduced, the efficiency of clinical trials could be improved which could then lead to faster drug approval. 

Conclusion 

Clinical trials are an essential component of drug development, however, given the multitude of factors involved, their inefficiencies require a multifaceted and collaborative approach. The integration of advanced technologies, patient-centric methods, and regulatory cohesiveness is important to improve clinical trials and drug development as a whole. 

Key areas of improvement include using AI/ML and digital health tools in order to streamline data collection, improve recruitment strategies, and enhance regulatory compliance. Also, using patient-centric trial design would help improve retention through fostering transparency and personalize participant support for both patients and their families. Furthermore, regulatory harmonization is also crucial. Encouraging regulatory alignment from different regions by invitation like the ICH could help with both time and financial burden when conducting international trials. 

By addressing these inefficiencies, the clinical trial landscape can become more cost-effective, timely, and reliable. Improving clinical trials, research will not only accelerate the development of new treatments but also help improve patient access to these treatments. 

About Centrova

Centrova is committed to transforming the landscape of clinical trials by breaking down the barriers that traditionally limit access to research opportunities. Every patient, regardless of their location or the size of their healthcare provider, should have access to the latest clinical trial opportunities. Centrova is democratizing research participation and accelerating the development of effective treatments through the decentralized clinical trial model by facilitating the resources needed to engage in clinical trials. Our goal is to ensure that all patients, no matter where they are, have the opportunity to contribute to and benefit from the latest advances in medical research.

By Karena Brijlall

Doctor of Pharmacy Candidate 2026