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PRECLINICAL TESTING AND CLINICAL TRIALS – Credihealth Blog

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Preclinical test facility helps you to reduce body disease. During the preclinical testing process of developing a compound for medicine, the compound in question must go through phases of testing. First, it is necessary to identify a potential target to treat a disease. Multiple compounds are then screened, and any that show potential as a drug to treat the disease must undergo toxicity testing before clinical trials to reduce the potential for harm. 

Clinical trials are medical research studies that engage sick and healthy volunteers to test treatments to prevent, identify, or cure disease. In many cases you have to need for preclinical te

Medical researchers are constantly proposing and reviewing new and existing treatments, diagnostics, and surgical procedures and devices. The clinical trial is the only reliable method to determine what is effective for patients and what risks are involved.

How is a clinical trial carried out?

In order to answer a clinical question, the research team determines a clinical trial protocol with all the relevant information of the study, with the aim of obtaining the approval of the competent authorities, an Ethics Review Committee.

The process depends on the type of clinical trial you might be considering. For example, clinical trials, which determine whether a new treatment should be adapted, must verify whether it is more effective than the standard treatment already in use, without causing unacceptable consequences for patients. Nevertheless, a clinical trial relies on the synergy of a research team with doctors, nurses and possibly other health care professionals who work closely with patients, in addition to statisticians and computer specialists who analyze the test results. Studies are conducted in universities, medical centers, clinics, hospitals or even in doctors’ offices.

If you want to take part in a clinical trial or have offered to take part, a qualified member of the research team will explain the details to you and you will have the opportunity to ask them any questions you have during a face-to-face meeting (see section). You will receive all required information in writing. You will need to fill out a form, sign it and return it if you decide to participate (this is informed consent).

If applicable, the trial team will review your condition, provide you with instructions for participation, carefully monitor any side effects and improvements you may experience during the trial, and keep in touch with you afterwards. 

Are there different types of clinical trials?

The most important difference between the studies is whether they are interventional or observational.

Interventional clinical trials, as the name suggests, require participants to try some type of treatment, “tested” under strict, well-defined rules outlined in the study protocol. Randomized clinical trials are interventional studies, considered to be the most reliable tools used to collect information on the efficacy and safety of treatments, because they allow researchers to reduce possible confounding factors (bias ).

However, setting up a randomized clinical trial is not always possible, sometimes for ethical reasons, but in other cases because of the costs and the length of time required or the type of questions that the essay aims to solve. In addition, the time and number of people required to be able to examine rare adverse effects through randomized trials would be too great.

Observational studies therefore represent another possible method for evaluating the effects of treatment. Participants are “followed” – observed – sometimes for years, to better understand risk factors, possible effects of exposure to certain substances, lifestyles, etc. Although they can provide useful information about daily practice, possible risk factors, or safety issues, observational studies are potentially more prone to bias because participants are not assigned to groups in a specific way. random, and their results should be studied in new clinical trials, if possible.

For example, the efficacy and safety of hormone therapy for menopause have been evaluated over decades by observational studies. Groups of postmenopausal women receiving treatment or not receiving any, have been observed for years by research teams to assess the benefits (control of menopausal symptoms, prevention of cardiovascular disease, prevention of osteoporosis , prevention of endometrial cancer, etc.) and the risks (breast cancer, appearance of cardiovascular diseases, etc.).

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What are the phases of clinical trials?

The clinical trial process is very rigorous and usually consists of 4 different phases when researchers test a new drug. Each phase serves a distinct purpose, allows the research team to address different treatment issues, and involves different risks and benefits that affect you.

Clinical trial registries tell you about the active phases of any clinical trial you might think of.

As already indicated (see the introductory box) the process described below is more typical of the development of new drugs, but also applies to any other type of intervention when determining the doses, placebo, etc., which may sometimes not be relevant.

Disclaimer: The statements, opinions, and data contained in these publications are solely those of the individual authors and contributors and not of Credihealth and the editor(s). 

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