As a MedTech or biotech company conducting a clinical study, you might be asking yourself: “What is a clinical trial protocol, why do I need one, and who creates trial protocols?” Every clinical investigation needs a well-designed clinical trial protocol, so these are great questions to ask and ensure that you have answered. Lucky for you - we’re going to do that here. 

Table of Contents:

• What is a clinical trial protocol? 
• What are the initial steps in developing a protocol for a clinical trial?
• What are the main types of trial designs?
• What else is important in a clinical trial protocol?
• What does all of this mean?
• How can CROs like Proxima help?
  

What is a clinical trial protocol?

The clinical trial protocol is a document that outlines the plan for a clinical trial. It contains information about the study objective, the study design, the methods for collecting and analyzing data, patient recruiting criteria, and any ethical and regulatory stipulations. The protocol is critical in ensuring that clinical research is carried out properly, and ethically, and that the findings are accurate for any regulatory submissions or journal articles.

In designing your protocol, you’ll want to ensure you are incorporating all the relevant sections so that you are aligning with GCP. Drug trials and device trials generally have the same structure but may follow different specifics based on whether they are following ICH-GCP guidelines or ISO 14155.   Let’s  dive further into the steps for creating a  protocol and the types of trial designs.

What are the initial steps in developing a protocol for a clinical trial?

The protocol development process begins by determining the research question or hypothesis that the trial will attempt to address. This could be a brand-new concept, or it might be supported by earlier research or observations. 

After deciding the research question, the next step is to design the study in such a way that the research question can be reliably and accurately evaluated. To do this, you will want to first consider the type of trial design necessary to address the study objective. You’ll also need to consider the feasibility of many aspects of the trial, including the anticipated patient recruitment rate, the schedule and type of assessments, the number of sites needed, and the ability to analyze the data in a meaningful way.

What are the main types of trial designs?

Clinical trials can make use of a variety of study design types. Two common trial designs are randomized controlled trials and observational studies:

• Randomized Controlled Trial (RCT): Participants are randomly assigned to receive either the experimental treatment or control treatment, like a placebo or a standard treatment. By doing so, it is easier to account for any biases and identify differences between the experimental and control groups and assign them to the experimental treatment. 

• Observational Study Trial: Participants are not put into treatment groups at random. Instead, while individuals receive their standard treatment, the researchers watch and record the results. Although these studies can be helpful for determining a treatment's effectiveness in the real world, they are typically less reliable than randomized controlled trials since they are more subject to bias.

Regardless of the study design selected, the clinical trial protocol must have very detailed specifications on the participant inclusion and exclusion criteria, the interventions that will be administered, and the methods for data collection and analysis. As a result, this decreases the chance of bias and ensures that the results of the experiment are more reliable.

What else is important in a clinical trial protocol?

The clinical trial protocol must include information about the safety precautions that will be implemented to keep participants safe. This might cover information on the monitoring of adverse events, how to address unexpected events, and how to withdraw trial participants.

Once the clinical trial protocol has been developed, it must be reviewed and approved by the HREC (Human Resource Ethics Committee) and/or the IRB (Institutional Review Boards) before the trial can begin. The ethics committee is then responsible for ensuring that the trial is ethically and scientifically sound and that the participants' rights and welfare are protected.

What does all of this mean?

To put it briefly, the clinical trial protocol is essential to the development of drugs and medical devices. It offers a plan for the trial and ensures that the outcomes are repeatable and can be applied to improve patient care. Additionally, it imposes time and budget estimates.

By following a well-designed protocol, research teams can feel confident that the results of their trial are reliable and can be used to benefit others. Once your protocol is approved, you are ready to carry out your clinical trial. 

How can CROs like Proxima help?

Finding a trustworthy and approachable CRO can make this process much easier. As a MedTech and biotech CRO with extensive experience in managing numerous successful studies, Proxima leverages past experiences and lessons-learned to improve current and upcoming clinical trials. 

Let’s have a look at the Proxima approach and the services we offer for your Clinical Trail Protocol:

• After working with your team to get an understanding of your study’s objective, indication, and timeline, our writers will draft the first protocol for you, incorporating any feedback, concerns, and/or revisions.
• We will consider the regulatory impact of that study design if the study is planned to be used to support a future regulatory submission.
• We will ensure that the final document is compliant with IRB requirements.
• We will assist you in preparing the right tools in advance to assist the sites and patients in coordinating the logistics of the study (i.e., study operations manual, patient sample instructions, etc.)
• We help foster a high level of transparency and communication between you, Proxima, and the study site. 
  

You don’t have to (and shouldn’t!) do this alone! Proxima understands the nuances of these complex tasks and has a highly qualified team to make sure you receive the consultative care you deserve.