Medical research with human participation is known as clinical research. It may take the form of a randomized controlled trial or an observational study and is designed to take the findings of basic science and apply them to improve the lives of individuals. Clinical research can be used to carefully consider the pros and cons of different medical treatments for both patients and healthcare systems.
Costs
Ultimately, outcomes in clinical trials aim to help inform healthcare decisions, whether by patients or health professionals. It is possible to gain knowledge about the efficacy of various therapies or medical interventions by analyzing the findings of clinical trials and other investigations. The resulting information can be used to determine the most effective treatment or procedure for a patient, which may improve the quality of life or save lives.
The costs associated with a study can include personnel, supplies and data analysis. The amount of personnel required varies depending on the nature of the study. So if there are more patients involved, it might cost more to run the tests and carry out the necessary analysis needed for these results. however, there are corners that can be cut with this. For example, by utilizing a software-based solution like this LIS system from NovoPath, which is full of features that support a modern laboratory’s operations to improve efficiency and performance, certain costs associated with a study can be cut as the processes will be simplified thanks to the software.
While cost-containment is an important consideration for the healthcare system, the importance of quality should be noticed. Outcomes research can provide the necessary tools to determine the best medical practice for individual patients and to ensure that all parties involved in a patient’s health care receive optimal outcomes.
The benefits of clinical research can be immense for both participants and the medical community. Participants benefit by trying new treatments or procedures that are not yet available to the general public and gaining a better understanding of their illness. Those who participate in clinical research can also help scientists make advancements that will benefit humanity for future generations.
Primary Outcome
The primary outcome measure in clinical research must be clearly defined during study design. It is important for two reasons: it reduces the risk of false-positive errors caused by multiple statistical tests of many outcomes. It also enables the study to be designed and powered appropriately to address the research question.
A primary endpoint must be well-defined in the study protocol, definitive concerning the disease process, and not require subjective assessments by investigators or patients. It should also be measurable over a reasonable period. It may be necessary to monitor several outcomes as secondary measures to help interpret the results of the primary product.
Secondary Outcome
As a trial progresses, it is important to be sure that the primary and secondary outcomes match the research question. It is where problems often arise in trials and is why the CONSORT guidelines suggest a thorough list of potential products for any clinical trial. These should include what is known as a hard (biological or statistical) measure, a quality of life score or instrument, and a risk score change. A trial may have multiple composite or other endpoints, which must be clearly defined upfront. Having too many secondary outcome variables can result in a less focused study and a difficult interpretation of the results. Similarly, more primary endpoints must be maintained to maintain the trial’s power calculations.
It is often helpful to design a trial with a composite primary endpoint if it would take more work to estimate the effect of an intervention on one particular event. However, the components of such an endpoint must be chosen judiciously so that the researchers can be confident in interpreting the results. All analyses of both primary and secondary outcomes should be published in the paper on which the original study is reported. It is the most efficient way for the scientific community to use a study’s findings. It also reduces the risk that some of a trial’s secondary analysis will be buried in footnotes or a separate publication and missed by readers.
Adverse Events
Clinical research tests new drugs or medicines, medical devices and treatment regimens to determine whether they are safe and effective for people. It may also try new ways to diagnose or measure the extent of disease or determine what causes some diseases. Clinical trials can be conducted at hospitals, clinics, research centers, universities, doctors’ offices and over the Internet. Some studies follow participants for a few weeks, months or even years. Other studies only observe people in their normal settings and ask about their health habits or behavior. Using observational studies, researchers can find potential novel therapies or preventative measures to evaluate in clinical trials.
During a clinical trial, an adverse event (AE) is any unwelcome side effect of a study medication or procedure. AEs can be mild, such as nausea or headache, or serious, such as a heart attack or stroke. Researchers try to keep AEs to a minimum during a clinical trial by following strict guidelines for evaluating and reporting them. Serious AEs result in death, require either hospitalization or prolonged hospitalization, cause permanent or significant disability/incapacity, create a congenital anomaly or congenital disability or significantly interfere with a participant’s quality of life. Other important medical events, based on the judgment of the appropriate medical authority, should also be reported.
