Clinical research studies are critical in discovering new vaccines, oral medications, therapies, and medical treatments. But contract research organizations (CROs) and other research bodies face numerous challenges, such as encouraging people to participate in clinical trials, government pressure, cybersecurity risks, and the high cost associated with advancing technologies.
Despite these challenges, many research companies have ventured into conducting more studies because of the high demand for new healthcare products. The demand for more effective drugs and sophisticated medical equipment in the healthcare industry is increasing. Therefore, frontier pharmaceutical or healthcare companies manufacturing the latest medical equipment and supplies generate higher revenues.
But what makes a clinical study successful? Read this article to learn more about requirements, regulatory compliance, and other relevant clinical research basic info.
1. In-Depth Understanding Of Clinical Research Standards
The standard-creating body, Clinical Data Interchange Standards Consortium (CDISC), sets specific requirements for CROs and research firms to follow. The CDISC collaborates with regulatory bodies, including the Food and Drug Administration (FDA). This non-profit organization develops and disseminates information about acquiring, exchanging, submitting, and archiving clinical study data.
One of the CDISC standards is the Study Data Tabulation Model (SDTM). With SDTM, researchers can use the guide to create human clinical trial data tabulations. These tabulations are a must in an FDA product approval and other regulatory agency product application.
Clinical researchers must know the basics, such as National Cancer Institute- (NCI), CDISC-, and SDTM controlled terminology, to understand the underlying concepts and subsets better. Without basic clinical research knowledge, CROs encounter communication gaps, data inaccuracies, and longer marketing authorization.
2. Full Compliance With Clinical Research Standards
The CDISC standards serve as the language of clinical research studies. Before a pharmaceutical company can launch a new vaccine, oral drug, or cancer treatment on the market, it needs marketing authorization from the FDA. Non-compliance can lead to a slow regulatory process, which leads to costly expenses and prolonged timelines.
On the other hand, a pharmaceutical company that follows the CDISC standards can quickly obtain authorization. That’s because FDA reviewers can promptly review the details of the study without confusion and error.
Aside from the STDM, another CDISC standard is Clinical Data Acquisition Standards Harmonization (CDASH). This CDISC standard guides in building case report forms (CRFs) in clinical research across therapeutic areas.
While SDTM standards tabulate data, CDASH resolves data capture needs to ensure clear clinical research questions. That way, the study can generate consistent answers. Complying with and maximizing CDISC standards help in quicker data collection, analysis, reporting, and approval.
3. Automating Clinical Research
Conducting clinical research studies costs a lot of money, and automating clinical studies is one way to offset the costs associated with traditional methods. In the past, data collection in clinical trials was manual. When technology evolved, CROs digitized clinical research forms. But poorly designed forms can lead to study inaccuracies.
Automation can help CROs obtain accurate clinical study results from initiation through completion. Researchers can finish interviewing more subjects and submit filled-out forms to the next study stage. Moreover, this technology can automatically generate case report form (CRF) templates and annotations.
Aside from CRF development, the other study areas to automate include clinical metadata management and dataset conversion processes. CROs can use centralized systems for clinical metadata management. These systems enable them to store and handle metadata assets, including CRFs, datasets, controlled terminologies, and revision checks for clinical research studies. With standardized metadata, CROs can reuse these assets, saving time and money in creating new ones.
Dataset conversion involves submitting and resubmitting data following the CDISC format. This process can be time-consuming. The FDA can quickly review and approve clinical studies with automatic dataset conversion. It eliminates complex programming to introduce new medications and treatments to the public.
4. Good Communication And Collaboration
The most successful clinical studies have good communication and collaboration workflows. If medical researchers, patients, and other staff members understand each other, there’s no room for gaps, loopholes, errors, and miscommunication. Therefore, every CRO or research facility must design a good communication and collaboration workflow.
Automating communication and collaboration workflows using a centralized system is essential to attain this goal. Aside from embracing relevant communication technologies, CROs should promote the human factor. For instance, greeting patients warmly and talking in a friendly manner can help them express their thoughts and emotions about the study findings more openly.
A successful clinical study entails full compliance with industry and regulatory standards. Clinical research firms must embrace the latest technologies to ensure accurate data gathering, analysis, and reporting, particularly in data management and governance. In that way, clinical research studies generate more positive results that can benefit more people, saving and improving their quality of life.