CLINICAL TRIALS: The reality and how they are carried out.

From asking many patients what they think of clinical trials, I have found the replies are always dependent on their experience. If the trial seemed a success, it was a happy response. If the clinical trial made a limited difference to their health, they were usually unhappy with them. If a loved one had died whilst in a trial, they were very unhappy and regretted the involvement with the trial

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 Doctor examining patient, author unknown but donated to Wikimedia Commons, from the National Cancer Institute, USA.

Different phases of a drug therapy clinical trial

There are usually three or four phases to a clinical trial. The first and second trials have the greatest risk for the patient. It is testing the unknown therapy for the (short term) safety of taking the drug/s and trying to work out how effective it is to treat the condition/s. The results can be a good, bad or weak response to taking the treatment, noting any side effects. It may be one drug, possibly engineered, or a combination of drugs. In a phase 1 trial, often fewer patients are tested. If the therapy passes the  phases successfully over time, then it may be offered to the public and possibly used as a routine treatment. https://www.cancerquest.org/patients/clinical-trials

The final decision to do so is likely made on the cost of developing and supplying the drug and its delivery to the patients, or whether the government can foot the bill to provide the therapy.

Timing for the political party accepting the drug/s on the Prescribed Benefits Scheme when close to an election, is normally good for votes.

What is a clinical trial?

Clinical trials are often designed with at least 2 equal groups. Selection for the groups should be by chance.  One group, if you are lucky (or maybe not), will reflect current medical thinking to treat the condition or disease, the treatment group. The second is the control group where nothing more than the standard treatment for the disease previously established is offered. The standard of nursing care, the clinics are the same, often with the same nurses, but with a rotation of interns for consultants. The trial is carried out “blind” to the patient, in a way that you are unaware if the treatment is a standard or new treatment. The treatment is not to be changed or interfered with, but it can be stopped if the effects are too bad.

The control group is important for scientific support of the findings, to compare the success or failure of the new therapy. It is better done with patients under the same conditions, care, and facilities with the only difference being the therapies. These trials especially for Cancer, are done in hospital based clinics. The results can depend on the care given in the hospital and cannot be generalized to other hospitals or countries. There, the trials must be repeated.  https://www.australianclinicaltrials.gov.au/what-clinical-trial/how-clinical-trials-work#B

What are your chances?

You think you have better than a 50/50 chance taking a clinical trial? Not really. You only have the certainty that if you are selected for the treatment group, it is a modern therapy. Unfortunately for Cancer Treatments, Oncologists get it wrong sometimes. The treatment has the possibility to be worse, equal with, or better than the current established therapy. Results from clinical trials can range from a progressive treatment to a devastating failure. One trial I witnessed was on post stem cell transplant patients. They were encouraged to take the standard vaccine protecting against measles, mumps and rubella viruses just like a baby would have at 6 months. The Doctor told me the immune system of a post-transplant adult at 6 months was equal to a 6-month-old child’s. All the patients that I knew on that trial died. Some I can confirm regained their disease shortly after their injections. The trial was to last for a short 6 months. The results took less than a fortnight to appear after the injections were given. Trials can and possibly do go wrong. Also, this type of trial is less likely to be published, so there would be less access to the results.

 

With this knowledge consider carefully whether to enter a clinical trial. Upon diagnosis you become desperate for a cure. The reality is entering a clinical trial may or may not give you an answer. If you feel strongly to enter the trial so to progress the treatment for your condition, regardless of your result, then that is a good reason to participate. Be aware for any other reason that you enter the trial, your chances for a successful treatment with the trial are at times less than you would expect.