It can be a scary-sounding term, but clinical trials are vital for the research, production, and delivery of thousands of important drugs and other therapies. You might be surprised at this list of what’s available to companies and academics hoping to start their research.
Clinical Trials and academic endeavours, in general, are expensive processes. Between supplies, staff, and production costs, it can seem impossible to begin. However, look at your local university that specializes in medicine and they will most likely have research bursaries. These are designed specifically for those who are trying to fund their way into their first research project, and thus, clinical trial.
In Vivo vs In Vitro
The idea of using living cells as a model for testing is often seen as morally grey, but modern In Vivo (live samples) models are specifically cultured to show even the smallest deviances in drug effects. Essentially, the In Vivo results are more accurate and safer than those In Vitro (dead/synthesised samples).
Gene therapies and genetic modification are other breakthrough areas in the industry. Whether you’re using genes to deliver your chemical or trigger it, or to grow large amounts of complex living data, gene editing is not to be overlooked.
A more approachable way of editing genes is gene delivery through a PiggyBac system. These systems allow whatever cargo you have created to be inserted into an already existing genome thread. Essentially, you add your own version of genomic DNA to a line of original genomic DNA through the use of transposon and transposase in the cells.
The Regulatory Bodies
Across the world, there are regulatory bodies to protect researchers, subjects, and the public from clinical trial errors. Knowing these and understanding when you will need to be in contact with them is essential to planning a trial.
- Protocol Review and Monitoring Committee (PRMC)
- FDA (Food and Drug Administration)
- CBER (Center for Biologics Evaluation and Research)
- Health Insurance Portability and Accountability Act (HIPAA)
Your NDA’s or Other Documents Must Allow People to Leave
As part of that previously mentioned regulation and safeguarding, clinical trials can be opted-out at any time when using volunteer or selected participants. Trials need Informed Consent, and these details will be made clear to any who takes part.
Your Results Should Be Published
Mandatory reporting of results seems like an obvious regulation to have, but with thousands of studies going on at once, that amount of data often misses some of them. To ensure the information online and in papers is up to date, clinicians should make sure they are publishing results clearly and having them checked. The “hidden” results that exist now can be used to mislead people, be it as statistics in adverts or just to protect the reputation of the trial.
You Can Change Your Mind
Even though clinical trials are so strictly budgeted and scheduled, using modern technology to receive instant test results means you have time to change the direction you are taking the drug. For example, if you find out your drug increases a biological function you hadn’t thought of, you can pivot the study to investigate why, how, and most importantly, if that change can be useful. Sometimes, it’s best to stop the study and start a new one armed with this new info, but often the schedule and budget and regulation work will all have gone into this trial, so it’s best to continue in this new direction.