Eilogics Clinical Trial Design Atlanta

The design of a clinical trial refers to formulating sequential and structured activities aimed to determine a causal relationship between multiple existing factors and variables.

A causal relationship, which may also be referred to as a cause-and-effect relationship, occurs when one variable directly impacts another. All trials begin with a research question to establish this casual relationship.

Clinical trials begin with a single group of participants. These participants— the cohort chosen to represent a population— may then be divided into several groups. These groups then receive either interventional or comparator treatments and are observed to determine the outcome and the efficacy of the interventional treatment.

Phases of Clinical Trials

Phase I trials typically test an experimental intervention on a small group of relatively healthy people. This is done to ensure the safety of the drug and monitor side effects and correct dosages. The number of participants at this stage varies between 20-80.

The number of participants increases in Phase II. Here, the focus is on the efficacy of the drug rather than its safety. This phase attempts to gather statistical data on the specifics of the intervention, such as its impact on people with certain conditions. This phase can be lengthy and typically measures short and long-term side effects.

Phase III gathers even more comprehensive data about the efficacy of the drug, studying different dosages, populations, and interactions with other drugs. At this stage, the number of participants can range from a few hundred to 3000 people. The Food and Drug Authority approval is acquired at this stage if they deem the intervention, device, or drug safe.

After FDA approval, the trial progresses to the fourth stage, where the intervention is monitored at large. It may take several years for certain side effects to become clear. Therefore it’s important to continue monitoring at this stage.

Types of Clinical Trial Design

There are several different forms of clinical design trials, as detailed below. Each form is picked according to the needs of the treatment being tested. EILogics clinical trial design Atlanta ensures that each trial is conducted reliably. For a clinical trial to be effective, several strategies can be adopted.

The research question should be clearly and adequately defined. Vague questions will, over time, lead to confusion. Therefore, they should be developed into quantifiable hypotheses. Once this is done, the research team can identify and address the core challenges of the study.

Furthermore, it is highly imperative to reduce variables. Any confounding variables could lead to unreliable results that do not clearly define the effect of the treatment. Having standardized definitions and consistent parameters can help address this issue. EILogics clinical trial design Atlanta ensures that these issues do not impact your trial.

Control Group Trials

One form of the trial depends on the presence or absence of a control group for comparison. Control or comparison groups are used to establish the internal validity of a trial.

Controlled Trials

Uncontrolled trials determine how toxic or effective a drug is without establishing a control group. Results of these trials can be obtained by comparing them with older published studies.

Uncontrolled Trials

The participants in controlled trials are compared with a control group that receives either a placebo treatment or a different treatment. Both groups are studied parallel to one another to understand the treatment’s impact.

Participant Allocation

Another form of a trial depends on the method used to assign participants to groups. This includes:

Randomized Allocation

A randomized clinical study is a study wherein participants are separated into groups by chance and given different treatments or interventions. Randomly allocating participants gives the best chance of knowing the effects of the treatment, and the results can be compared more objectively. This is typically practiced if it is not known which treatment is more effective at the time of the trial.

Non Randomized Allocation

In non-randomized clinical studies, participants are assigned to interventions using controlled methods. This is done if random allocation would reduce the effectiveness of the intervention. Effectiveness in this context refers to the capability of the intervention to produce an effect in the real-world setting.

Group Allocation

Group allocation also plays an important role in how a clinical trial is conducted, as the chosen method of allocation can help reduce bias and increase the reliability of the trial.

Open-Label Studies

In open-label studies, both the participants and investigator are aware of which intervention and group the participant is allocated to. This trial is used to draw comparisons with different treatments or gain information about existing treatments, such as side effects or long-term effects. The open-label method is also used to gather safety information, increase market interest, and gain trust from prescribing clinicians and the general public.

Open-label trials can play a key and legitimate role in clinical research as long as they are well-designed and follow specific protocols of their own. EILogics clinical trial design Atlanta ensures that your clinical trials are designed with all the nuances of the intervention in mind.

Blind Studies Single and Double

In contrast to open-label studies, either the participants or both the participants and doctors are not aware of the intervention they are being given or the group they’re allocated to. Single-blind studies involve not informing the participants, while double-blind studies involve both the doctors and participants not knowing.

Blinding is used to reduce bias and increase the validity of the results. Not only is it important to blind the participants and the doctors, but also any other practitioners or reviewers to ensure the reliability and validity of the trials are not impacted. For trial designs, EILogics clinical trial design Atlanta can ensure that there is no bias tainting the trial results.

Superiority and Non-Inferiority Trials

Non-inferiority trials are used to demonstrate that the new intervention provides at least the same effects as the comparison intervention. Superiority trials are used when comparisons are made to placebo treatments, which are not meant to have physiological effects, or vehicle treatments that contain relatively inert substances.

Equivalence Trials

This trial is used when the primary goal is to show that two or more treatments do not differ in a clinically significant amount. This trial proves that two or more treatments do not differ by a clinically insignificant amount.

This is usually established by proving that the true treatment difference lies between a lower and an upper equivalence margin of clinically acceptable differences.

Intervention Structure

The structure of how the intervention or treatment is given to participants can impact the study.

Parallel Trials

A parallel study involves two or more groups of participants receiving different interventions. Participants are allocated to different groups that remain the same throughout the trial. This allocation is typically randomized.

Parallel trials are advantageous, as they provide a way to assess the efficacy of a drug on survival. If there have been concerns about carryover effects, a parallel study can help determine whether the intervention is responsible.

Crossover Trials

Crossover trials involve participants receiving the same two or more treatments. However, the order in which they receive them varies based on which group they are randomly allocated to. If a group is receiving drug A first, followed by drug B, the alternating group will be given drug B, followed by Drug A.

Crossover trials are advantageous compared to parallel trials, as they can reduce the influence of confounding variables because each crossover subject acts as a control for themselves. Furthermore, optimal crossover studies require fewer subjects and are, therefore, more efficient.

Sequenced Trials

In sequenced trials, patients are arranged in pairs, one allocated to the control and one to the interventional group. Results are analyzed and used in addition to previously obtained data. The sample size is not predetermined.

The Bottom Line

Clinical trial design is an important aspect of trials that can help optimize and ensure an intervention’s efficacy, safety, risks, and side effects. It is important to ensure that your clinical trial is economical, optimized, and ergonomic to ensure the most valid and reliable results. EILogics clinical trial design Atlanta ensures that your trials are conducted fairly and without