Clinical Research Design

Investigaciones

Table of contents

Clinical investigations are trials that seek to test the efficacy and safety of new treatments and medicines, as well as those that have already been approved. Clinical research is designed with a number of parameters in mind in order to achieve a positive outcome for a medicine or treatment. These parameters include the patient population, the type of treatment to be investigated, and the objectives of the study.

Research or clinical trials that involve volunteers aim to detect diseases, diagnose them and measure their spread. Trials offer an excellent way to find out what works in treating diseases, and some even investigate ways to prevent them. Clinical research is therefore very important and can take many years to complete.

Phases of clinical research

Clinical trials are usually conducted in different phases, the results of which determine whether the new medicine or treatment to be tested is effective and safe. The results of one phase are of great use for the next phase and provide knowledge about what is known so far about the treatment or disease being investigated.

On the other hand, before a clinical trial can begin, it must be approved. Researchers must submit an application to begin research on a new medicine, so that a decision can be made as to whether the treatment is safe to be tested in people. The application must include information about the research team, the study protocols, what the medicine contains, and who is producing it, among other information. The study sponsor must agree to obtain consent from each participant, follow all rules, and submit to review by an institutional review board.

Pre-clinical (or laboratory) studies

Once the application is approved, the results of pre-clinical studies, also called laboratory studies, must be obtained before clinical trials can begin. While they provide useful information, preclinical studies do not cover everything that needs to be known. This is partly because humans and animals react differently to medicines or treatments.

In the following, we will take as an example the pre-clinical studies that are carried out in the case of drug research and cancer treatments:

  • Cell studies: to determine whether a new treatment is likely to be effective, how it reacts on cancer cells grown in a laboratory dish is analysed.
  • Animal studies: treatments that appear to be effective in cell studies are then tested on live animal cancers. This allows researchers to get an idea of how safe the new treatment is in a living being.

It should be mentioned that in many cases, trials compare two populations, called the treatment group, composed of people receiving the treatment, and the control group, composed of people receiving a placebo or a different treatment. When selecting research participants, the aim is to ensure that there are no variables outside the study that could influence the outcome.

Types of clinical research design

Research designs can be divided in several ways. Firstly, they can be divided according to how participants are allocated to the treatment or control group.

On the one hand, allocation can be randomised and controlled. In this case, study participants are randomly assigned. People have an equal chance of being part of either group. Within randomised studies, there are two types:

  • Parallel group design: each participant gets the same treatment throughout the study process.
  • Cross-group design: each group of people first receives one treatment, and after a period of drug rest, gets a different treatment.

On the other hand, the study can be controlled and non-randomised. In this case, the allocation is not randomised, but the researcher is the one who assigns people to the different groups.

Another way of dividing clinical research designs is according to the participants’ and/or the researcher’s knowledge of the group to which they were assigned. This type is divided into:

  • Open clinical research: Participants and the researcher know which study group they have been assigned to.
  • Single-blind clinical research: in this type of trial, the participants do not know which group they have been assigned to, but the researcher does.
  • Double-blind clinical research: In this case, no one knows which group each participant has been assigned to.

Finally, clinical research designs can be divided according to the researcher’s intervention:

  • Observational clinical research: the researcher does not interfere, but only observes what happens in the process.
  • Non-observational clinical research: in this case, the researcher assigns a study factor and controls it throughout the research.

Certain comparators may also be included in the design. These are called comparative trials and are categorised as follows:

  • Superiority or inferiority: shows that the drug under investigation is better or worse than the control.
  • Equivalence: shows that the drug is similar to the control.
  • Dose-response relationship with the target: determines dose-related parameters.

As we have seen throughout this article, clinical research is crucial to prevent, detect, diagnose, and measure the spread of diseases, as well as to determine the safety and efficacy of new treatments and medicines. Good clinical research design is essential.

At Ambar Lab we offer more than 3,000 laboratory tests, support in business management and the development of new projects. We work to ensure that our wide and growing catalogue of tests, as we know that knowledge is the key that facilitates our clients’ work. Contact us if you have any questions and visit our blog to keep up to date with all the latest news in the clinical field.

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