What are clinical trials?
Clinical trials are studies to find out whether the drug is safe and effective for people. It is the end result of many years of research. Research occurs in many places, such as a pharmaceutical company or university labs. A clinical trial takes the development of the discovery to test in a population where it can impact health. The people who take part in trials are volunteers. They may be patients with a specific disease, or healthy people wanting to contribute to the advancement of medical knowledge.
What is the process for a clinical trial?
It is a long process, often taking 15-17 years between the research and the approval of a drug or medical device or therapy. The goal is to try to introduce new therapies. Clinical trials must be approved by Health Canada in Canada or by FDA in the USA. There are various phases of clinical trials. In both countries, there are 4 phases of clinical trials. Each has its purpose and answers a certain question.
What do I get by participating?
Clinical trials often offer benefits to their participants. Many offer early access to cutting edge treatment that’s not available to others. You may be cured and even if not, your quality of life may improve. In addition, another perk may be access to expert care because of the time spent with the research team.
Sometimes it is hard to find volunteers for clinical trials. It is because many people do not want to be a guinea pig. All clinical trials come with risks. It can be a serious side effect because the effects of the drug are still under investigation. The risks have to be well explained and understood. Every person who participates in a clinical trial must give their informed consent before beginning the trial. Health Canada clinical trial regulations are strict in order to protect people’s health, ensure that the studies are well designed, conducted and monitored, and side effects are reported to Health Canada. All trials have to be reviewed by Research Ethics Board.
Who can participate in clinical studies?
Sometimes the requirements for a clinical trial are very specific. Each trial is different and requires a different number of participants and they have to qualify. After careful screening for age and presence of certain risk factors about 80% of volunteers do not meet the criteria set out in the trial.
Cancer trials are getting smaller and smaller because the researchers are looking for specific genetic markers and/or tumor specifications. Certain types of cancer have the same markers. Cancer clinical trial participants in phase 1 usually get a chance to try a new therapy. A healthy person will never receive cancer drugs. So, the volunteers for those are much different than other over the counter new possible drugs.
In the US, those with cancer that have tried everything suggested by a doctor and not responding to treatment can use the FDA’s expanded access program. If approved, they can reach out to the drug manufacturer and ask to try a drug. FDA approved more than 99% of applications under its expanded program.
What are the success rates for clinical studies?
Hematology or blood-related clinical trials tend to be most successful. Least successful trials are in oncology, which can be very discouraging. Sometimes discoveries never make it to a phase of clinical trial. The large majority of targets will fail before they even reach the early stage of phase 1 of a clinical trial.
It is somewhat easier to test a drug than a therapy or a device because you administer a chemical vs placebo and you observe a certain outcome. In therapies or exercise studies it is a much more subjective question of how a therapy or exercise impacted participants and how many people felt the improvement.
A new study carried out at MIT has found that the likelihood of a drug at Phase I making it all the way to the market is 13.8%
What are the resources for clinical trials?
In conclusion, we list some helpful websites that will be able to provide you with more information about clinical trials and how to access them. As always Health Vantis is happy to help with any questions you may have in regards to access to medical help. Contact us toll free 877 344 3544 or email us at firstname.lastname@example.org