Featured article by Evheniia Smilianets, Head of Digital Communication OnlineCRF LLC
Clinical research is one of the most critical areas of the pharmaceutical industry. Its main task is to study the safety and efficacy of new drugs before they enter the market. These studies are conducted with the participation of volunteers (patients).
All processes in the clinical trials involve a number of difficulties and risks. Specialists in this field are primarily responsible for the health of patients who will use the medicine. Therefore, the entire scope of clinical research is regulated by regulatory documents, standards, and procedures. This makes it field conservative; therefore innovations in clinical trials are much more difficult and take longer to introduce than in other areas.
How IT technologies were previously involved in clinical trialsÂ
A few decades ago, most clinical trials were conducted on paper. Data on the patient’s health while taking the drug was collected on paper Case Report Forms (CRFs).
Imagine that during the study, the patient comes to the doctor five times a year. Each of these visits corresponds to at least one sheet of CRF. Moreover, about 50 patients participate in one study – that 250 sheets of paper just to start. And if such a study lasts five years, then the number of paper documents grows even faster.
We gave an example of a small study, but there are also large-scale projects that can last more like ten years and include more than 500 patients. Such data volumes are very difficult to manually qualitatively analyze. There is also no way to scale and accelerate clinical trials because every time everything depends on lengthy work with data on paper.
This state of affairs greatly impeded the development of the sphere of wedge research and slowed the appearance of new drugs on the market. That is why progressive pharmaceutical companies began to introduce IT systems to optimize problematic processes, and eventually — to complete the entire study.
Such a transformation took time because it was necessary to adapt the documentation to new IT solutions to prescribe a number of new standards. But despite all this, the benefits of using electronic systems outweighed the negatives.
Today, about 75% of projects are carried out using electronic systems, and this number is growing every year.
What problems do IT technologies solve in clinical research?
Consider the main difficulty points and how they could be simplified through the introduction of IT systems.
Effective drug development
This is a process that precedes a clinical trial. It is about finding formulas for drugs that will subsequently become the basis of a new drug. To find such a substance, it is necessary to analyze several thousand variants of various molecules and draw conclusions about their potential effect. This work involves a huge amount of data. Manual analysis can take more than one month and is totally ineffective.
That is why special computer simulation programs are used to search for new substances. They help to quickly analyze different variants of the molecule and select promising substances for further work.
Clinical trial speed optimization
Thanks to the use of special programs for clinical research, the speed of the project can be significantly improved. This is mainly due to the reduction of delays during the study.
The fact is that a clinical study involves many participants, often from around the world. It is very difficult to supervise their work without special programs, so delays and inconsistencies occur regularly. And this affects the overall duration of the study.
Special Clinical Trial Management Systems (CTMS) and Electronic Data Collection Systems (EDC) provide support. It helps responsible managers see the full dynamics of the trial, quickly identify problem stages and eliminate delays.
Improving the quality of the drug data collected
Information about the safety and efficacy of drugs should be reliable and properly collected. Before the using of IT products, information processing could take a lot of time. Due to the influence of the human factor, the data often contained errors and inaccuracies, and this required additional time to review and clarify the information.
However, with the advent of electronic data collection systems (EDC systems), data collection has become more efficient and easier. These systems allow the investigators (doctors) to enter and save information in an electronic database. EDCs are equipped with various input verification systems. Automatic checks do not allow doctors to save erroneous data and oblige them to check it. This greatly improves the quality of the final database and allows for reliable statistical analysis in the future.
EDC systems also simplify the work with data. All information about the patient’s health is stored electronically in one program. If necessary, responsible research participants can easily access them. Information cannot be lost or mixed up, as it is stored in a structured database on secure servers.
Clinical trial cost reduction
The use of IT technologies in clinical research makes trials more effective both in terms of time and budget.
The Function of Data Collection Systems (EDC), Clinical Trial Management Systems (CTMS), and other types of programs take clinical research to a whole new level. They help reduce a lot of costly items of expenditure and optimize resources. Therefore, with the competent use of such systems, clinical trials become much cheaper as a result. The clinical trial rate is a significant component of the final drug price. Therefore, in reducing the cost of research, the price of medicine for patients lowers.
Today, IT technology plays a valuable role in clinical research. It is thanks to the introduction of such programs that this sector is able to become more flexible and effective. And this plays a significant role in the emergence of new drugs and their accessibility to patients.
