Olla Peeps! In this article, I will be talking about Pilot Study. Yes, you read it right. Pilot study plays a crucial role. It is a mini pre-study which is conducted before a full-scale research project. It helps you out to answer various questions regarding a big scale project. I will be talking about following points in this article:
- What is a Pilot Study?
- Pilot Study in Clinical research
- What is the purpose of a Pilot Study?
- Misuses of a Pilot Study
So, let’s get started with our article.
What is a Pilot Study?
A pilot study is a mini-scale, pre-study which aims to find out that whether important components of a main-study will be beneficial or not. It is basically an RCT, i.e., randomized controlled trial. RCT’s need a lot of money and time to be carried out.
Therefore, it is important that the researchers have confidence in the initial steps that they will take while managing this kind of study. It is done to avoid wastage of resources and money.
Example: Pilot study or you can say, RCT (randomized controlled trial) is used in the attempt to foresee an accurate sample size for a full-size project. It is also used to improve upon different aspects of the study design.
The work of the pilot study is also to answer a simple question, i.e., “Can the full-size study be managed in the way which has been planned or should some of the component(s) be altered?” Another important point which you should keep in mind is that the reporting of a pilot study must be of high quality. It allows the readers to understand the implications and results correctly.
Pilot Study in Quantitative research and Qualitative Research- Clinical Field
A pilot study can be conducted in both qualitative and quantitative studies. The focus goes on quantitative pilot studies, specifically on those which are done before full-scale phase III trials. There are phases of the trials. I know it sounds a bit tough to understand, but don’t worry as I will explain these to you.
Phase I trials include non-randomized studies which are designed to define the pharmacokinetics of a drug. It defines that how a drug is metabolized and distributed in the body. A perfect amount of dose is figured out which can be tolerated by the body with lesser toxicity.
Phase II trials give preliminary evidence of the clinical strength of a drug. This trial may or may not be randomized. Here comes, Phase III trials which are randomized studies. In this phase, more than two or more drugs or intervention strategies are compared to monitor the safety and strength.
Phase IV trials are done after marketing or registration of a drug. These are not randomized. These are survey-based studies which are documented experiences after the usage of the drugs. It includes any side effects of the drug, interactions of the drug with other drugs, etc.
How Pilot Study helps in clinical practices?
As we now know that a pilot study provides crucial practical data but, it also provides an excellent opportunity for study teams to establish good clinical practices to grow the reproducibility and rigor of their research.
It includes development of informed consent procedures and development of documentation, regulatory reporting procedures, data collection tools and monitoring procedures.
The aim of a pilot study is not to test the hypothesis. So, it is not compulsory to give power analyses for the suggested sample size of the pilot study. Instead of this, the recommended pilot study sample size should be taken according to feasible considerations. It includes budgetary constraints, participant flow and the number of participants required to reasonably calculate feasibility goals.
What is the purpose of a Pilot Study?
Pilot studies are conducted to calculate the practicability of some vital part(s) of the full-scale study. Basically, these can be broken down into four main aspects. Below are those four aspects.
- Process- Here the practicability of key steps in the full-scale study is monitored. For example retention levels, recruitment rate, and eligibility criteria.
- Management- the problems are looked upon regarding data management and also with the team included in the study. For example: were there any issues while collecting the data required for future analysis; is the collected data highly changeable and whether the data collected from various institutions can be evaluated together.
- Resources- It includes monitoring the issues with resources and time, that may arise during the main study. For example: how much time will the main study take to get completed; will the use of some equipment be practical or whether the form(s) of assessment chosen for the main study is good enough.
- Scientific- It deals with the monitoring of treatment safety; estimation of treatment effect, its variety and determination of dose levels, its response.
Let me conclude this section with some points which will cover all the above mentioned four aspects.
Reasons to conduct a Pilot Study
- Monitoring the practicality of a full-scale survey/study.
- Testing and developing the effectiveness of research instruments.
- Checking whether the technique and the sampling frame are effective.
- Designing a research decorum.
- Monitoring whether the research decorum is workable and realistic.
- Monitoring the success of suggested recruitment approaches.
- Finding out logistical issues using the suggested methods.
- Calculating variability in outcomes to help finding out the sample size.
- Collecting initial data.
- Deciding what resources (staff, finance) are required for a planned study.
- Monitoring the proposed data analysis techniques to expose potential issues.
- Preparing a research plan and research questions.
- Guiding a researcher in various elements of the whole research process.
- Assuring funding bodies that the research team is knowledgeable and competent.
- Assuring funding bodies that the main large-scale study is practical and thus is worth funding.
Misuses of a Pilot Study
Well, Pilot studies are very helpful, no doubt but, then there are some drawbacks. There are few misuses of pilot studies as well. Rather than focusing on practicality and acceptance, many times, pilot studies focus on unsuitable results like deciding “Initial efficacy.” Following are the common misuses of pilot studies:
- Attempting to monitor tolerability/safety of a treatment.
- Aspiring to provide an initial test of the research hypothesis.
- Evaluating effect sizes for power calculations of the bigger scale study.
Below are some questions which usually comes on to one’s mind after reading above points.
Why can’t we use a pilot study to monitor tolerability and safety?
When it comes down to investigators, they often prefer to examine “initial safety” of involvement in a pilot study. But, due to small sample sizes, generally involved in a pilot work, they can’t give useful information related to safety, except in few extreme cases.
In most of the involvements suggested by investigators, suspected safety concerns are rare and minimal, and thus, they are unlikely to be picked up in a small pilot study. If there are no safety concerns demonstrated in a pilot study, then the investigators can’t say that the involvement is safe.
Why can’t a pilot study provide an “initial test” of the research hypothesis?
We see specific goals for practical pilot studies which propose to estimate “initial test” of involvement B for condition Y. Well, there are two basic reasons why a pilot study can’t be used for this purpose.
- When a pilot study is conducted, there is lesser knowledge about the methods which should be applied to the intervention within the patient population. So, there is no surety whether the intervention works as you don’t know if it has been applied correctly.
- Due to the small size of the samples used in a pilot study, they are not efficient to answer the questions related to efficacy. Thus, any evaluated effect size is uninterpretable.
So, guys, I hope that now the concept of a Pilot study is clear to you. Pilot studies play a crucial role in health research, but it is also possible that they might be misused, misrepresented or mistreated. One needs to be very careful when it comes to a Pilot study.
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