Clinical trials have a research site request and a supply crisis. Here’s how to solve it

Clinical research sites face an information challenge that hinders efficiency and collaboration. As the complexity of the tests increases, multiple connections, devices and spreadsheets use site staff to carry out studies create partitioned work currents. In addition, each sponsor has its favorite software solutions for each test, which means that the collection, access and sharing of data a tedious effort. The result is overloaded investigators who are too thin.

The impact is a significant capacity on site and probably explains why a recent survey report has revealed that more than half of the clinical sites have trouble assuming new trials. A significant drop in doctors in clinical research – from 5% to less than 2% per year – aggravates the problem. Stressing the imbalance of supply and demand, 29% of sites that take a trial fail to register patients.

Realizing that fewer sites participate in the tests, the industry is starting to meet and meet the basic needs of research sites. Sponsors, CROs and sites discuss real challenges and solutions to improve the efficiency of trials in workshops and forums. This is an important step towards a solution.

Site personnel in narrowing, increased the problem of tools

As the demand for trial sites increases, training tools and requirements reduce the overall functional capacity of a site. This creates an extended difference between need and capacity, and disparity directly affects the effectiveness of clinical trials. The sites represent the heart of clinical research because they perform trials, collect essential data and provide care for patients. However, they are overloaded by the requirements of the study.

In its heart, this is aggravated by technology intended to make the processes more effective. Without meeting interoperability challenges and improving site processes, industry may block innovation to the point where it is most necessary. The use of more technology is not the best approach, as more than 60% of sites use more than 20 applications per day.

Three key challenges are the cause of this problem. The first is increasingly complex study conceptions, where the growing number of data points and test procedures complicate execution. For example, a recent report on the TUFTS impact indicates that phase 3 trials have increased 41% of procedures, diagnostics and laboratory work.

Staff shortages are an important factor in site supply, as talent pools in clinical research are shrinking. Sponsor teams also become smaller. Associated with the slowdown in doctors in research and a lack of research nurses – a nurse for 10 open positions – the industry faces a shortage of human resources.

Finally, the sites are invited to use too many different technologies. More than half of the sites say that managing several systems is their main obstacle to efficiency. Connection to various applications with different interfaces, configurations and frustrating identification information staff and slows down the processes.

Develop a more holistic approach and at the level of the clinical research industryH

The industry approach to solve the problem of the site’s capacity has historically been to add more technology. While some more important sponsors and CROs have tried to introduce internal portals for more consistency, these efforts are insufficient due to a lack of integration between the tests.

A more holistic approach to industry can reduce the burden of clinical sites. Many sponsors are starting to standardize the processes and technology between trials for smoother operations. This is aligned with what sites require, because many express the desire for standard and simple approaches to the execution of the tests.

A recent survey carried out by the Society of Clinical Research sites on site, Sponsor and CRO collaboration revealed that sites massively prefer integrated systems and the coherent adoption of solutions between sponsors and CROs. These sites require a central platform that works on several sponsors and tests, reducing the number of systems with which they must interact daily.

Sites can benefit from a standardized platform, reducing the number of applications generally used in a unique system which incorporates essential functionalities – such as document management, data collection and regulatory compliance. This approach allows data to flow transparently, which saves time for site staff focused on basic search activities and patient care.

To meet the different requirements of each study protocol, industry can apply universal best practices and standardized training programs. For sites, this change can considerably reduce the learning curve for new studies and, in turn, accelerate the initiation and execution of tests.

Collaboration with research sites to apply a more holistic approach to clinical research can help reduce the duplication of data and minimize errors while improving precision. With standardized systems and processes, stakeholders can quickly share and access data in real time to make informed decisions.

Advance clinical research careers

Beyond an approach more connected to technology, the simplification of test workflows can make clinical search careers more attractive. Tests with less administrative tasks can reduce the chances of exhaustion of investigators and coordinators. Changes could encourage more professionals to stay in the field and make it more attractive for new graduates.

With a planned growth rate of 9% per year, clinical research offers difficult and fulfilling work. However, he is not aware of recruiting new entrants. The addition of clinical research as a career at US Census Bureau is a first positive step that the association for Clinical Research Professionals (ACRP) continues before the next survey. The organization requests a new profession code for the clinical researcher within the framework of the Code of Health Professionals 29-0000 and the Technical Code.

Awareness is essential to stimulate growth in the field and help make a breach in the clinical research research crisis. Improving the sustainability of the career thanks to improved work environments, competitive remuneration and professional development opportunities is also essential for the long -term success of industry.

Collaboration to go from a chaotic crisis to a unified solution

The industry listens to the challenges of research sites and takes measures to meet them. By integrating technology, by normalizing processes and giving the site staff time to focus on what they care (treat patients), sponsors and CROs can stimulate the speed and efficiency of clinical trials.

Investment in the construction of the workforce and the realization of clinical research An attractive career is also necessary to guarantee long-term sustainability. Training programs, incentives to clinical investigators and improved site support structures help fill the gap between supply and demand. Regulatory organizations and industry leaders can start by working together to establish policies that encourage standardization of processes and data while promoting innovation in the execution of clinical trials.

These efforts are barely starting to scratch the surface. Working in close collaboration with sites, sponsors and CROs can provide a more efficient and scalable model to conduct trials. This transformation will ultimately benefit patients, ensuring that important new therapies reach those who need it the fastest and effectively.

Photo credit: Appledsign, Getty Images

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