Navigating the task of choosing a clinical research partner can be daunting, as many trial sponsors have emphasized. Our skilled team has curated valuable insights on effectively executing your clinical trials. Let our Chief Commercial Officer, Barry Skillington, lead you through this essential process.
The clinical trial process
From the inception to the conclusion, the process of conducting a clinical trial involves numerous essential steps:
- Initiating the start-up phase; conducting preliminary research, designing the protocol, developing the statistical analysis plan and electronic case report form (eCRF), and training study teams.
- Submitting and obtaining regulatory approval for the protocol.
- Engaging in advertising, recruiting, and screening potential participants for the trial.
- Subsequently transitioning to the implementation phase of the trial, where data collection takes place, followed by thorough analysis and reporting of the outcomes.
The study team
One of the most important parts of a successful clinical trial is the research team, which should include study coordinators, research assistants, clinicians, project managers, and lab assistants just to name a few. It is important that every team member has proper training on Good Clinical Practices (GCP). When conducting human trials and when evaluating candidates for your teams, it's important that they come from a variety of personal and professional backgrounds.
Our Clinical Research Investigator, Alice Eggleston, highlighted during a presentation about tips for implementing clinical trials:
“The study team should be able to pick up on the minutia of the protocol that they're able to adhere to and requirements of the study procedures, it's important that these team members are team-oriented. Participants may be a different phase within the protocol, so it's important that they communicate well with each other, but also with the sponsors, with the study participants, and that they also have high-quality written skills. Study documentation in clinical research is extremely important. If it's not documented, it didn't happen. So to be sure that the team understands the importance of what they're doing and are able to communicate effectively within the team, but with all, with also the sponsors and the participants”.
The clinical trial protocol
Developing a protocol is obviously a vital process, since the design of the trial, the study population, the investigational product, the study procedures, are all described here in the protocol. Alice stated that the protocol should be scientifically sound which translates in:
- It should have a thorough explanation of the previous research done and evidence of why this project is relevant and the description of the study population should be realistic to carefully select the population of interest, yet not be too specific so that too many people are deemed ineligible.
- The protocol should outline expectations that are feasible for study participants to adhere to. the outcomes should be translatable or generalizable to the greater population. The language in the protocol should be clear and detailed so that anyone reading the protocol will come to the same understanding of the ins and outs of the trial, stated our Clinical Research Investigator.
- The protocol will need IRB approval from a central or local institution to ensure ethical considerations are being met.
- It's important to utilize validated tools and questionnaires if you want the results to be recognised by both academia, regulatory institutions, and industry peers.
- Many of the protocols that we implement utilize specialized technology, used for study participant monitoring, for things like imaging or biomarker monitoring adapted to the health area of research. You should be advised to choose reliable, stable and recognised biomarkers by the scientific community.
- Lastly, having a sound stats plan is not only key in analyzing the data once participants have fully conducted their visits, but also at the beginning of the trial. It's important to have this stats plan in order to have a vision of how the trial data will be collected. So be sure to have the input of a statistician at the start of the trial to have it consistent throughout the conduction of the trial.
In summary, make sure you have a well-trained clinical research team, a protocol that is carefully thought out and feasible. Our Chief Commercial Officer, Barry Skillington, added:
“Flexibility in the protocol, to a certain degree, allows you to move things around as needed to be or make changes through amendments. You certainly don't want it very rigid. Sometimes recruitment can be challenging, and you might need to change criteria, and sometimes the client may see something in raw data that makes them want to make a change. All manner of scenarios happen in clinical trials, as you can well imagine. Nothing is outside the realm of possibility”.
Clinical Trial Financial considerations
Another important component of the clinical trial is the financial piece. Conducting a clinical trial from end to end varies greatly depending on the duration of the trial and the number of participants. Clinical trials are not cheap, and the cost is visual across a number of visits, the number of subjects, and number of questionnaires and biomarkers. The research partner you are working with should provide you with a very clear and transparent breakdown of setup costs per subject, per visit. Some costs to be considered for the start-up: building of the Electronic Data Capture (EDC), regulatory costs, recruitment costs, data analysis. While there are many factors to consider when you're selecting tools, budget is usually the key driver. The selection of appropriate tools, technology, and questionnaires has a huge impact on the clinical trial costs. Barry highlighted:
“We advise sponsors to pick the best tools. We try to reduce redundancy on the data collected to optimise the Sponsors budget, however, the client might want to have that duplication in purpose. There is some overlap in some of these questionnaires. These decisions vary depending on subject origin and budget. It's always good to get as much data as we can collect. We advise collecting as many objective and subjective measurements if you feel there's any benefit to your trial. It's very difficult and expensive to collect it at a later date. It's relatively cheap to collect, freeze and hold the samples if stable. If you think that might be a benefit, you can do further analysis later. It suffices to say, there are a lot of tools out there that are free. But again, you get what you pay for. And the free tools can be perfectly fine for what it is you're trying to do.”
Make sure you have justified financial considerations, a solid study participant recruitment plan that will carry from beginning to end of the trial.
Study population
Active participation in the study is crucial for its success. Without engaged study participants, the trial cannot progress. It is essential to carefully define the inclusion and exclusion criteria, ensuring that the recruitment team targets relevant individuals who can meet the study requirements. Finding suitable participants can be challenging, underscoring the importance of having a sizeable and committed volunteer pool. Barry Skillington, our Chief Commercial Officer, emphasized the precision needed when selecting participants for studies on sensitive topics like sleep, mood, and anxiety. Expert guidance from clinicians and psychologists is essential to develop effective screening tools and identify candidates who exhibit the condition under study but also have room for improvement. This meticulous approach is key to establishing accurate baseline outcomes and maximizing the potential for observing positive effects.
"This is probably the single, most important point when you're setting out your inclusion and exclusion criteria due to the sensitive nature. We would strongly advise that you receive expert advice from clinicians, psychiatrists, psychologists, in order to guide and advise on the correct screening tools so that the right candidates are brought forward. The right candidate needs to be somebody who has the condition that we're talking about, but has room for improvement. The sensitivity of tools is key to ensure that the baseline outcome is correct and to optimise your chances of seeing an effect.”
Conclusions on how to select a Clinical Research Partner:
Based on our expert's feedback, we would highlight the following as key factors when selecting a clinical trial service provider:
- A scientific approach all the way through study design to trial reporting;
- Ability to access participant or patient communities that correlate with real-world populations;
- A good understanding of the Ethical and Regulatory Approval processes;
- Aware of your financial strategic considerations when selecting endpoints, tools, eligibility criteria;
- Flexibility, transparency and open communication
- A good understanding of your clinical research program and where you want to get to, whether it is to achieve a publication, a proof of efficacy or a tool to achieve further sales.
