A Guide to Randomized Controlled Trials for Students in Clinical Research College

For clinical researchers, randomized controlled trials (or RCTs) offer a useful approach for obtaining excellent data. Selection bias can dramatically hinder clinical studies, by distorting outcomes and adding additional variables to an experiment. RCTs attempt to remove this bias as much as possible.

The randomization of experimental and control participants allows research to focus solely on the outcome, without adding extra variables. Read on for a guide to randomized controlled trials and how they will aid in your studies and beyond.

The Advantages of RCTs

In an RCT, two or more groups of participants are compared, some who receive an experimental treatment and some who receive no treatment, a current standard treatment, or a placebo. One of the things that makes RCTs so effective is how participants are placed into these two groups:

1) Participants that meet the study’s criteria are recruited
2) They are randomly assigned to one of two groups
3) The participants in one group receive the experimental treatment
4) The participants in the other receive no treatment, a placebo, or a standard treatment

By making the assignment process random, this approach removes bias and external factors that can affect outcomes and skew results. Having a control group also allows researchers to compare the results of both groups, and determine exactly how much of an effect the intervention had.

It is the best, most rigorous way to test interventions in clinical research. Sitting at the top of the hierarchy of evidence, these trials are considered more effective than both cohort and case control studies.

RCTs are at the top of the hierarchy of evidence

Allocation bias is removed, improving the chances that there will be no difference between people who received the experimental intervention and those in the control group. These studies have become the standard for pharmaceutical companies and as a student in a clinical research program, they will likely be an important part of your future career.

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Allocation Concealment and Blinding

As a clinical researcher, maintaining impartiality is a top priority. This is why allocation concealment is important.

What is allocation concealment? Allocation concealment helps make sure that the person assigning patients does not know whether they are assigning them to the control or intervention group. For example, they might simply hand out sequentially numbered, opaque, sealed envelopes.

However, while allocation concealment is used in blinded studies, it is not exactly the same as blinding. Allocation concealment takes place when assigning patients, but once this has occurred, if a study is not blinded, then clinicians and even participants might know which group is which.

Blinded or masked RCTs prevent those involved in a study from knowing which intervention was received by each participant.

Single blind: Participants don’t know which group they belong to

Double blind: Clinicians and participants don’t know which group the participant belongs to

It is important to protect randomization of allocation in RCTs

Blinding is very useful, but in certain trials it will prove inappropriate. For example, if a trial requires active participation of a person, it is impossible to conduct a blinded study.

Graduates of a Clinical Research Program Know RCTs Help Prevent Tampering

For students and graduates of clinical research college, it is essential to ensure the integrity of all trials. It is necessary to prevent not only accidental but also deliberate manipulation of trial results.

Why would tampering occur?

• To make a treatment appear more effective than it is
• To make a treatment appear more dangerous than it is
• To hide the negative effects of a particular treatment

For example, a company that has invested significant funds into a particular treatment might be overly eager to prove its effectiveness. Because of this, having systems in place that eliminate the possibility of intentional tampering will prove useful.

Researchers make sure to design trials that cannot easily be tampered

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