When we take a pill to treat an infection or undergo surgery to address a more serious issue, we usually don’t consider how that treatment came to be. Still, each medical intervention, whether it comes in the form of medication, therapy, or surgery, has to be approved by a body of scientists and experts before it can be provided by medical practitioners or pharmacists, and that approval process can be costly.
From migraine medication to endometriosis therapy, all medical treatments have to undergo similar kinds of studies to ensure that they’re both effective and safe. Keep reading to learn more about what makes up the high cost of your average clinical trial.
The Clinical Trial Phases
Each pill, vaccine, or diagnostic test you undergo must be studied thoroughly before approval. This includes behavioral, medical, and surgical interventions, among others. The hope is that medical providers can use the treatments to help or save the lives of others after the interventions have received approval.
In order to get that approval, a new treatment must complete four clinical trial phases. Once each phase has been completed and approved, the clinical trial can move on to the next step.
- Phase I: Safety – The treatment is tested for safety and the dosage is established. This phase includes an average of 15 to 20 healthy volunteers.
- Phase II: Efficacy – Also known as the Proof of Principles study, this phase looks at how effective the new treatment is, and may have up to 500 volunteers. In this Phase, individuals that participate usually have the disease for which treatment is intended.
- Phase III: Clinical Benefit – Phase three compares the new intervention with the old treatment to see which has the best outcome, and it can involve around 5,000 volunteers.
- Phase IV: Side Effects – Lastly, the long-term risks and benefits are studied, a process that can last years.
Each phase is very important to ensure that any potential problems are caught before it moves on to the next step in the trial. Unfortunately, each phase can cost a lot of money.
What Makes Up the Cost of a Clinical Trial?
Clinical trials are usually very costly, and most studies require several million dollars to complete. In fact, the average clinical trial for a new drug costs around $19 million. That is certainly a lot of money, and it’s important that each dollar is spent with care. Usually, studies spend a similar portion of their funding on a few key categories:
- Around 20% is for clinical procedures.
- 20% is also the average for staff and administration.
- On-site monitoring can cost around 14%.
- Site retention averages 12%.
- Around 8% is for lab costs.
- About 25% is used for patient recruitment and other miscellaneous costs.
A lot of money is needed to perform a clinical trial, but the final dollar amount for a medical study has many variables.
Factors That Affect the Cost of Clinical Trials
While all clinical trials use a similar framework to determine their phases, the details and actual application of those phases can vary widely. When it comes to the cost of a clinical trial, there are a few key factors that can impact the overall cost:
- The number of patients involved in the study
- The number of clinical sites needed
- The number of countries included in the trial
- The type of medical intervention being studied
- The number of tests and procedures needed for each phase
As you can imagine, the actual cost of a clinical trial can change depending on the type of research, where the trial is based, the disease for which it is intended, and how complex it is.
Support Clinical Trials for Endometriosis Relief at Sur180 Therapeutics!
In most cases, medications that have gone through the approval process still have side effects, and they may not be totally effective. This is why it’s essential to continue clinical trials to find improved treatment for current health concerns and medical intervention for those without any.
All women deserve the best healthcare we can give them. At Sur180 Therapeutics, we are working diligently to find better healthcare for women needing endometriosis therapeutics. Join our cause by supporting us in our research!