Clinical research is a healthcare science branch that determines the safety and effectiveness of diagnostic products and treatment regimens intended to be used by human beings. The fundamental tenet of clinical research involves the collection and analysis of data from human participants to gain an understanding of research hypotheses.
On the other hand, standards in clinical research refer to set guidelines and principles that ensure the quality, accuracy, and consistency of research methods used by clinical researchers. These standards inform the parameters for data collection, analysis, reporting, and other ethical considerations in clinical research.
The most commonly used clinical research standard in the US is the Clinical Data Interchange Standards Consortium (CDISC), which the Food and Drug Administration (FDA) mandates for anyone looking to conduct clinical research and trial. The CDISC created research standards for clinical trials, healthcare, and the pharmaceutical industry. From CDISC, many more standards have risen, including the Analysis Data Model (ADaM), which among other things, focuses on organizing data collected in human and animal trials.
Gaining further knowledge on ADaM, like how it facilitates confidence and transparency in clinical research data through its traceability features, shows precisely why standards matter in clinical research.
Here are pertinent reasons why standards matter.
1. Standards Allow For Transparency And Credibility In Clinical Research
The World Medical Association (WMA) Declaration of Helsinki, last amended in 2013, set the standards for clinical research. Part of the agreement governing clinical research was that a research ethics committee would scrutinize a research protocol before any clinical research study began.
This committee was granted full rights and access to monitor the clinical trial [mfn]https://www.healthline.com/health/clinical-trial-phases[/mfn] and allowed to receive a final report when the study ended. Such standards governing clinical research across the globe opened the door to transparency and credibility in clinical research.
The WMA also sets standards to govern scientific requirements, research protocols, and general principles to govern research protocols and the selection of clinical research participants.
2. Standards Improve Quality And Integrity Of Clinical Research
Standards provide guidelines on, among many things, data collection, management, and analysis. The research will be thorough, accurate, and consistent with these guidelines. Stringent guidelines governing data collected during clinical research improve the quality and reusability of data gathered.
Standards set the bar for clinical research accurate and fraud-free results. Other clinical researchers can then reuse these results to inform medical development in their own regions.
3. Standards Ensure Safety And Ethical Treatment Of Study Participants
Standards generally provide guidance that must take precedence regarding clinical research and trials. This is an essential requirement because clinical research, as defined earlier, deals with medical interventions that have the potential to cause harm to trial participants.
Some of the standards emphasized include:
- Informed Consent: Informed consent refers to providing a clinical trial subject with enough information to make an informed decision. Ethically, the investigators are also required to facilitate the trial subject's understanding of the information, obtaining their voluntary will to participate and allowing time to ask any questions they may have.
- Use Of Research Methods That Minimize Participant Risk: Good Clinical Practice (GCP) is a standard that dictates how trial subjects should be cared for when participating in clinical research. Some measures include documentation and addressing any adverse events or side effects during clinical trials, possibly avoided during future studies. While clinical research standards emphasize results, it insists that results should not be an adverse risk to a trial subject.
- Protection Of Participants’ Privacy And Confidentiality: Protecting the privacy and confidentiality of trial participants is critical to clinical research. It is essential to maintain the trust and integrity of the research process.
In summary, adhering to these standards in clinical research and trials is vital to ensure the safety, well-being, and ethical treatment of all trial participants.
4. Standards Encourage Collaboration in Clinical Research
In 1990, the International Conference on Harmonization of Technical Requirements for Regulation of Pharmaceuticals for Human Use (ICH) occurred. This clinical standard was the brainchild of the United States, Europe, and Japan. One of the aims of this organization was to make recommendations that would achieve harmonization in technical guidance interpretation and application for pharmaceutical product registration. Such a move, the three countries concluded, would reduce duplication of testing conducted during the development of new human medication.
ICH developed a document called Good Clinical Practice (GCP) which describes the clinical research guidelines to be followed by investigators (professionals conducting clinical trials), monitors, sponsors, and review boards. Having common collaboration standards has encouraged collaboration between countries in clinical research, reducing the need for research duplication and encouraging the reusability of data.
Parting Shot:
Standards have been built upon the tenets of reliable data and the ethical conduction of clinical research. Standards matter in clinical research because, when upheld, the results of clinical research not only give an accurate picture of the situation under investigation but also dignify human life. Therefore, clinical research standards have accelerated growth in the clinical research sector, in essence, improving human life.