Introduction to Clinical Research

Clinical Research

Clinical research is a type of science that incorporates human subjects. People voluntarily take part in carefully crafted studies that ultimately reveal better techniques and knowledge for disease screening, diagnosis, treatment, and prevention, as well as for promoting health and healthcare. Interventional or observational clinical studies are both possible. Research on how medicines work, studies on health economics, and qualitative clinical research like figuring out patients' experiences are examples of initiatives that fall under the category of observational studies. A participant in an interventional study is assigned to either the treatment or control group at the beginning of the study. Interventional studies are controlled experiments like clinical trials. "Interventions can include medications, cells and other biological products, surgical operations, radiologic procedures, gadgets, behavioural treatments, process-of-care improvements, preventative care, etc.," the WHO's International Clinical Trials Registry Platform explains. Studies may be conducted in a single location (known as a "single centre study") or over several places (known as a "multi-centre study"). The nature and scope of the research being conducted will determine whether a study is single- or multi-centered.

Clinical research is conducted to gather data on common and uncommon occurrences, conditions, and population groups to enable us to:

• observe health care delivery and management practises to understand how they can be improved;
• test interventions to create new drugs and vaccines; discover new applications for current therapies;
• and learn more about specific diseases to improve our knowledge of how to manage, treat, and prevent them.

The ultimate goal is to have a better understanding of how clinical research might be used to enhance health outcomes. Large-scale advancements in global health during the 20th century were mostly the outcome of clinical research expertise; examples include: In the 1920s, research revealed that enhancing children's diet helped fight rickets and other paediatric illnesses. Epidemiological studies conducted in the 1950s established the link between lung cancer and smoking. In the 1980s, studies showed that providing folic acid to high-risk pregnant women reduced the number of spina bifida-affected births. Clinical experiments conducted in the 1990s revealed that combining antiretroviral medications could halt the progression of AIDS.

The greatest potential for health improvement in terms of numbers exists in areas with the highest disease burden, such as low-income countries, and there is significant potential gain from very straightforward therapies. These areas stand to benefit the most from clinical research. However, these groups are currently underrepresented in global research efforts. Hopefully, ongoing and future research will result in more potent medications and vaccines to combat diseases like malaria, HIV, tuberculosis, and neglected ones like dengue and visceral leishmaniasis. These initiatives ought to enhance our knowledge of the various communities, groups, and individuals' healthcare needs as well as the medical services necessary to address those needs. The most effective strategy to improve health outcomes is through ongoing clinical research that is rigorous, credible, diverse and incorporates a range of people and communities.

Principles of Research Ethics:

The Belmont report outlines three fundamental principles that are especially important to the morality of research involving human subjects. The following are these three guidelines:

• Justice: No group should be unduly burdened with more research costs than they should, and everyone who participated in the study should be able to take use of the findings. In their work, Minnies et al. (2008) stress that "participants are particularly prone to research exploitation due to poverty, disease, lack of knowledge, hardship, submissiveness, the effects of war, starvation, pandemics, and social insecurity widespread in developing nations."
• Beneficence: Potential harms should be reduced, and potential gains should be increased.
• Respect for autonomy: Vulnerable people must be protected while the right of individuals to freely choose and act must be upheld.

An additional principle is listed in the "International Ethical Guidelines for Biomedical Research Involving Human Subjects" published in 2002 by the Council for International Organizations of Medical Sciences (CIOMS): Non-maleficence: A participant in the study shouldn't purposefully hurt or harm themselves as a result of their participation.

Clinical Trials

Data on the efficacy and safety of health treatments (such as medications, diagnostic procedures, medical devices, and treatment protocols) can be gathered through randomised controlled trials (RCTs). Depending on what the trial is examining and where it is in the development process, it may be undertaken using healthy volunteers or patients. Phase I to Phase IV are the typical trial phases:

• Phase I evaluates the safety of an experimental drug or treatment, establishes a safe dosage range, and identifies side effects in a small group of healthy individuals. There are typically less than 100 participants in this phase.
• Phase II studies the drug or treatment in a small number of patients to determine its efficacy and further assess its safety. There are often only a few hundred participants in this phase.
• Phase III involves testing the experimental drug or treatment on large numbers of individuals to determine its efficacy, track any side effects, compare it to therapies already in use, and gather data that will enable the safe use of the product. Several hundred to several thousand people typically participate in this phase.
• Phase IV, which is regarded as the surveillance stage, gathers more data regarding the drug's risks, advantages, and ideal application. The broader public will be involved in this stage.

Informed consent:

"Informed Consent" is the primary tool for guaranteeing a person's rights are protected. In order to obtain the possible participant's agreement to participate in the study, all study-related activities that go above and beyond standard care must be disclosed to the potential participant. Agreements for the conduct of clinical research were developed in response to well-known incidents like the Nazi experimentation on concentration camp inmates during World War II and the Tuskegee syphilis study (1932–1972) on black American men. These agreements, which also influenced the creation of the International Conference on Harmonization Principles of Good Clinical Practice (ICH GCP) 1996 standards, included the 1947 Nuremberg Code, the 1964 Helsinki Declaration, and the 1979 Belmont Report. Despite the fact that the ICH-GCP recommendations are for trials, the majority of the concepts can be used for any kind of study. These guidelines define informed consent as: ‘the process by which a person freely confirms their willingness to participate in clinical research after having been informed of all parts of the study that are relevant to the individual’s decision to participate’.

Future of Clinical Research:

Technology advancements and data analytics are projected to be the driving forces behind clinical research in the future, resulting in patient treatment that is more individualised and effective. Patient-centred outcomes and the use of real-world evidence to guide therapeutic decision-making are expected to receive more attention in the future. Decentralized clinical trials, virtual healthcare choices, and a stronger emphasis on diversity and inclusion in clinical research participation are further trends that are likely to continue.