How a unified approach to clinical trials can improve productivity and compliance
As organizations are focusing on improving clinical trials, they are faced with several challenges. By creating a unified approach that utilizes data-driven methods and technology, they can create unified clinical trials that offer sustained growth and productivity.
Unified clinical trials are built on a triangular approach—the need to make them more efficient, continued emphasis on patient centricity and improving adoption. However, sustained growth, productivity and compliance depend a lot on data and technology working together. Organizations need to build a cohesive and harmonized ecosystem that allows data to flow seamlessly and technologies to complement each other, thus improving patient outcomes.
Current challenges in clinical trials
The evolving healthcare ecosystem requires bringing innovative therapies to the market and improving patient outcomes. However, a number of challenges can impede the growth and value of life-saving therapies.
Increasing clinical trial development costs
The process of developing a new medicine is extensive and requires significant investment throughout the trial process. The average cost is estimated at more than 2.6 billion dollars, and a large portion of this cost is tied to inefficiencies and trial failures. This cost is derived from a number of factors, including access to advanced equipment, expertise and comprehensive data management systems not only burn resources but also increase the trial budget beyond sustainability.
Timelines and delays
From pre-clinical testing to the approval stage, clinical trial development can easily take up to 10–15 years. The process of seeking regulatory approval itself can be formidable and time-consuming. It can be a result of the complex trial protocols and amendments imposed by the governing bodies, site setups and failing to find suitable participants, often pushing approvals months beyond their original duration.
Higher dropout rates
A significant number of clinical trial participants often drop out before trial completion. While many trials fail to enroll sufficient patients in the first place. It could be because of various reasons, including the lack of awareness or accessibility, time consumption, burden of frequent site visit schedules and paperwork, poor communication, limited diversity in the trail design or simply due to inadequate digital literacy.
The traditional way of conducting clinical trials has long been the standard approach, often offering a fragmented experience. However, given that there is a need to meet the challenges head-on, life science organizations must shift from fragmented clinical trial development to a unified ecosystem. Life sciences consulting turns out to be beneficial for many organizations which often utilize a modern and transformative approach that involves both data and advanced digital technologies to help streamline the process and enhance every stage of the trial process.
The importance of a unified approach to clinical trials
The shift towards a unified approach that eliminates inefficiencies and delivers better outcomes across the clinical trial development is grounded in a few principles. But before that, what does unified mean?
A unified platform is referred to as an “all-in-one” solution that brings together capabilities across the full clinical trial lifecycle. From clinical data management to regulatory compliance, safety, and trial quality, everything is within a single, integrated system. The advantage, rather than relying on disparate tools, siloed clinical data and disconnected workflow, a unified platform centralizes the entire operations, automates workflows, simplifies vendor management, offers real-time visibility and enhances control over trials.
Platform Level Unification
At the infrastructure level, unified data solutions enable faster data collection by leveraging diverse technologies and data sources. From mobile applications to wearable devices, electronic health records (EHR) and telemedicine platforms, the consistent set of software simplifies workflows and improves outcomes. Organizations can utilize decentralized clinical trial (DCT) solutions for remote patient monitoring, reducing the need for patients to visit trial sites frequently.
Data Layer Unification
Clinical trials utilize data from multiple resources, be it structured, unstructured, internal or external. However, much of this data is scattered across multiple clinical systems and applications. Through a unified platform, organizations can centralize data to prevent duplication and make regulatory reporting and audits easier. This data can also be used for resource allocation, educating patients, optimizing trial operations and cost saving.
In the dynamic clinical trial development journey, unification is not without its challenges. However, by creating a cohesive and standardized system, life science organizations can expedite trials, reduce costs and sustain growth.