Planning a clinical trial: our checklist for getting started




Here at Citruslabs, our mission right now is to do everything we can to speed up the clinical trial process and keep clinical research moving forward during this global slowdown. To do so, we’ve joined the fight against COVID-19 by offering our patient-recruitment dashboard and databases free of charge for all COVID-19 clinical trials. Yet, this is only the beginning for us. We want to do more, and that’s exactly what we are going to do.


The leading cause of clinical trial errors, according to a recent study, is poor planning. For researchers right now, it can be so easy to get caught up in the rush for a vaccine that some basic mistakes can be made trying to understand the complex situation we find ourselves in. So, we’ve put together a short guide through the vital first steps of setting up a clinical trial that any researcher, regardless of experience, will appreciate. From nurturing an initial idea to applying for funding, whether you’re new to research or simply need a reminder, our checklist aims to keep your data quality and validity high.


1. Idea to Hypothesis


So, you’ve got your initial idea - or half of one at least; but where do you go from here? Whether it’s for a small behavioral study or a miracle cure, what you’ll need to produce, before you can even think about getting to work in the lab, is a problem formulation and a therapeutic model. In addition, for each of these, you should be able to explain them in terms of a scientific paradigm and a clinical paradigm. This may sound like a lot, so let's look at this step-by-step.


For clinical research, the scientific paradigm essentially asks this question: what do we know/have concluded about the body and how it functions? Or, in other words, what are the key anatomical theories that are universally agreed to be fact? The clinical paradigm, on the other hand, provides an overview of the methodology or approaches that were used to produce these results.


Problem formulation then is about determining the variables of your area of research that are already in play; firstly, from the accepted theory and, secondly, from the methodology used to determine these facts. The therapeutic model takes this information and looks to apply these theories and methodologies onto the pathophysiology of the disease. This will provide the backbone of your hypothesis, so it’s important to really nail the concept here.


2. Draft protocol


Now that you’ve got a good idea of the scope of what you’ll be working on, formulating a proper hypothesis and its objectives shouldn’t be too difficult (in theory). A research protocol is essential to formally explaining your ideas on the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, an excellent protocol should include the following topics:


  1. Title Page (General Information)

  2. Background Information

  3. Objectives/Purpose

  4. Study Design

  5. Selection and Exclusion of Subjects

  6. Treatment of Subjects

  7. Assessment of Efficacy

  8. Assessment of Safety

  9. Adverse Events

  10. Discontinuation of the Study

  11. Statistics

  12. Quality Control and Assurance

  13. Ethics

  14. Data handling and Recordkeeping

  15. Publication Policy

  16. Project Timetable/Flowchart

  17. References

  18. Supplements/Appendices


Paying attention to each of these areas should ensure that your trial doesn’t run into any unnecessary technical or legal issues. While poor planning may not be a top priority for pharmaceutical companies, it could have a critical impact on the research of independents. Unlike large companies, researchers can’t always rerun trials so it’s crucial that independents get it right the first time around.


3. Funding


Funding can be found from a variety of sources: government bursaries, charity funding, and company sponsorships are among the most popular. If you are situated in the US, UK, or wider Europe, here is a list of funding resources that you’re bound to find helpful. Note: All information pertaining to conditions and eligibility of application can be found on each company’s website.


United States of America


  • National Institutes of Health’s grant for COVID-19 trials:

https://grants.nih.gov/policy/natural-disasters/corona-virus.htm


  • The Gates Foundation’s grant for COVID-19 trials and other research:

https://www.gatesfoundation.org/How-We-Work/General-Information/Grantseeker-FAQ


  • NIH’s list of projects available for funding:

https://grants.nih.gov/funding/searchguide/index.html#/


  • US government grants:

https://www.grants.gov/web/grants/search-grants.html


  • National Science Foundation grants for a variety of areas:

https://www.nsf.gov/funding/index.jsp


United Kingdom


  • UK Research and Innovation’s grants for COVID-19 trials:

https://www.ukri.org/funding/how-to-apply/


  • National Institute for Health Research grants (COVID-19 trials funding also available):

https://www.nihr.ac.uk/researchers/funding-opportunities/


  • Medical Research Council’s grants for clinical trials:

https://mrc.ukri.org/funding/how-we-fund-research/


  • Cancer Research grants for independent researchers:

https://www.cancerresearchuk.org/funding-for-researchers/our-funding-schemes/clinical-trial-award-0


  • Stroke UK’s grant for disease-specific research:

https://www.stroke.org.uk/research/our-funding-schemes/project-grants


European Union


  • European Clinical Research Infrastructure Network grants for multinational trials:

https://www.ecrin.org/multinational-trial-funding


  • European Medicines Agency’s Horizon 2020 grants:

https://www.ema.europa.eu/en/partners-networks/academia/horizon-2020-research-funding


  • European Society for Medical Oncology grants (COVID-19 funding also available):

https://www.esmo.org/covid-19-and-cancer/supporting-oncology-professionals


  • Wellcome grants (COVID-19 funding also available):

https://wellcome.ac.uk/grant-funding



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