Clinical trials

Teresa Smit and Debbie Peters inform us of what clinical trials not only offer patients but healthcare staff too.

You can listen to this article below, or by using your favourite podcast player at pod.link/oncologybuddies

Clinical trials are a unique opportunity to get state-of-the-art treatment for free. They give patients access to new products and give healthcare staff valuable experience with these products. 

A clinical trial is not experimental in the sense that we do not know what to expect. Clinical trials available at oncology sites are mostly phase 2 and 3 studies, meaning by this time the pharmaceutical company knows the drug is safe and effective. 

As cancer patients are a vulnerable population, placebos (fake medical treatment that looks and is given like real treatment but has no therapeutic benefit) alone can’t be used in cancer trials. Patients should either receive the current standard of care or the new investigational product. Placebos can be used in combination with one of the above. 

How to get onto a clinical trial?

It’s quite tricky to get onto a clinical trial. There are usually 20 to 40 inclusion and exclusion criteria to comply with to be eligible. Some are straightforward (to be older than 18 years) and others are more complicated (like liver function or the biological type of the tumour). There is usually nothing the patient can do to increase his/her chances of being eligible for a trial. 

A patient can’t be forced to take part in a trial and should be given time to think it over and discuss it with family and friends. They should also be allowed enough time to ask questions. Before any procedures on the trial can start, an Informed Consent Form should be signed by the patient. 

This document gives all the information of the trial to the patient regarding treatment, timelines, adverse events, etc. It also shows the patient willingly agreed to be part of the trial. 

Patients are allowed to withdraw from the trial at any time. Even after treatment has started. Signing the informed consent doesn’t bind them to complete the treatment. However, once a patient decides to take part in a clinical trial, it’s essential to be compliant with the treatment, tests, and questionnaires (if applicable). Patients can be removed from a trial if they are not compliant. 

Screening period

Studies usually allow a 28-day screening period to show eligibility. During this time, baseline tests are done like vitals, height, weight, ECG, blood tests, CT-cans, MRI, bone scans, and confirmation of tumour biology (among others). 

If one or more of the inclusion/exclusion criteria doesn’t comply, it means that the patient will not be able to take part in the trial. If all criteria are eligible, the patient can be randomised to the trial. 

Patients are often concerned with the 28-day screening period, as being diagnosed with cancer is distressing and patients want to commence treatment as soon as possible. Trial patients are very carefully selected, and if the benefit of treatment doesn’t exceed the risk of waiting, they would not be considered for a trial. 

The patient’s medical history and chronic medication are all taken into consideration during the screening period. Usually, the patients should carry on with their chronic medication as prescribed, as long as the trial team is informed of them. If there are drugs that are contra-indicated (very seldom), replacements would be considered together with the patient’s treating specialist for that condition. 

It’s very important to not experiment with traditional remedies, over-the-counter supplements, and other wonder drugs while on a clinical trial (a multivitamin is acceptable). Many supplements (like green tea) impact the metabolism of medication in your body. This can make the trial medication less effective or more toxic. 

Who covers the cost?

The sponsor company of the clinical trial pays for all the activities requested for the trial (consultations, treatment, blood tests, scans, and a travel allowance). 

Over-the-counter medication (like scripts for nausea, pain, etc) isn’t paid for by the sponsor company. 

Oncology sites have to be registered and selected to be allocated clinical trials. 

Available trials can be found at clinicaltrials.gov