Behind The Clinical Trial

A clinical trial starts with an idea. Researchers in a lab notice something they haven’t anticipated, or think of something that could enhance the results they get that can also be applicable elsewhere.

Or, doctors after years of experience with patients notice a pattern that has them thinking of how they can verify their observations. A drug they’ve been prescribing reacts better when taken with a certain supplement or all of their patients that regularly meditate show better scans, or any other number of correlations that can be clinically tested.

If you’ve been wondering what goes on behind the scenes of a clinical trial, let us take you on this brief journey through the main stages of organising a trial. And let us clarify in the meantime what a sponsor is and what role pharmaceutical companies actually play in research.

So, you’re a researcher (or more likely, a team of researchers) who has an idea that seems to have a lot of potential. What are the next steps to take?

Well, in most cases, next thing is developing a protocol or in other words, a detailed plan of how your research is going to be conducted. A protocol includes all concerns on behalf of the potential patients as well as all of the procedures, legal and medical, that are going to take place or could take place under a number of circumstances.

We’re going to go more in depth about protocol of clinical trials in future blog posts but for now, let’s cover the bare minimum a protocol entails.

First and foremost, it answers the question of why the clinical trial needs to be conducted. It also covers number of patients, eligibility (the criteria you need to meet in order to enter the trial), treatment, tests and information – what kind of information will be collected, how it will be stored and kept safe and so on.

After protocol has been written down in great detail, researchers send it for ‘peer review’ also called ‘independent scientific review’. This means other scientists who are as unbiased as they can be, check the protocol for loopholes that might have been overlooked or possible improvements. The protocol is often reviewed by patients too.

Then, after the protocol has been established, the next step is finding funding for the trial. Trials can be funded by charities, the government or by pharmaceutical companies.

A common misconception is that pharmaceutical companies conduct trials. The truth, of course, is more complicated than that. While drug companies do sponsor clinical trials more often than not, the trials themselves are carried out by independent professionals binded by the protocol every party agreed to and was approved by an ethical review committee.

The clinic research team made up of scientists and medical professionals is led by what is called a ‘primary investigator’, a medical doctor in most cases. In addition to that, the work of the team and the data produced can be overseen (especially in big-scale trials) by an independent team of experts.

Even though the pharmaceutical company is covering the costs for the trial – and it takes a lot of money to conduct even a single trial, and even more to take a drug all the way to phase III clinical trials and FDA approval – it has no access to the data until the trial is over. It’s in the company’s interests to preserve the scientific integrity of the clinical trial they sponsor by making sure research is conducted by unbiased team of professionals according to regulations.

Now, let’s take a look at the costs drug companies cover and what exactly a ‘sponsor’ means. Costs of trials typically include:

Treatment, so the patient gets it for free
Research and health care staff
Technology to analyse the data
Administrative costs around protocol, reviews, collecting of data and so on
Tests, hospital stays and any kind of additional care that may be needed on the patients part.

A ‘sponsor’ covers all that. A sponsor is an individual, institution, establishment, company that funds the clinical trial but doesn’t conduct the research. The sponsor ensures proper monitoring of the trial as well as research being upheld to the utmost ethical standards and regulations. They also ‘communicate’ with the regulatory agencies on behalf of the trial.

So, there you go – that’s what happens on the other side of clinical research. If you have more questions, we’d be happy to clarify as one of the main goals of everyone involved in the world of medical advances is keeping research transparent and spreading the knowledge.