WHY CLINICAL TRIALS?

This is perhaps the best place in the arrangement of my contributions to this website to write to you concerning an important issue very much relating to the contents of the last blog post.  It is not at all unlikely as you begin to find your way around your particular department of oncology or come into contact with those who specialize in the treatment of cancer that you will hear the phrase (and may be invited to participate in) a “clinical trial”.  Everyone – patients and his or her families, as well as healthcare professionals – yearn for a ‘magic bullet’ response in the search for a cure for every form of cancer.

Thankfully, as has already been stated, some cancers can be cured, whilst others may be treated and brought under control (palliated) for extended and even indefinite periods of time.  But such success commonly comes at a price and part of that price (quite apart from weeks and months and even years of dedication and commitment on the part of researchers and the like) is the need for patients to sometimes give their consent to participate in and abide by the formal conditions of a clinical trial.

The aims, terms and conditions of all such studies are set out in a formal document, i.e. one for each study and known as a “research protocol”. This serves two discreet functions.  First of all the research protocol provides all necessary specifications of the trial procedure, in so far as it relates to individual patients.  Second, it clearly defines and determines the aim and rationale underpinning every such study and its overall design: nor is this solely for the benefit of ethical committees, funding bodies and the like. The validity and robustness of the study’s scientific design should not be perceived as a kind of straitjacket. Rather, it does and should ensure a realistic and scientifically orientated approach to the testing of hypotheses· concerning treatment or whatever is stated therein.

Everyone will appreciate that in order to try out a new treatment, it needs to be rigorously tested against the best currently available. But how precisely might that end be achieved?  Clinical trials are in fact divided up into phased approaches. Indeed, you may very well hear reference made to “Phase I”, “Phase II” and “Phase III” clinical trials and as we shall see, the reason for this is as clear-cut as it is methodologically sound.  Such a phased approach does, as I will explain, ensure that a given treatment e.g. a drug or some other treatment strategy is being properly and adequately identified and tested. Only if the stringent terms set out in the research protocol are fully met, will it be approved for use generally.

The primary concern about the use of drugs or treatments of whatever nature, must always be their safety – the province of Phase I investigations.  For example, in the case of a drug, dosage of how much is needed to achieve optimal effect without giving rise to damaging side-effects, will be studied.  Not infrequently, volunteers will be subject to increasing doses of the drug in question, according to some pre-determined schedule and these are known as “drug escalation” experiments.  (Bye-the-bye, volunteer subjects most commonly involved in such trials, may well be pharmaceutical company employees. Or then again, they may be patients who have not responded to such standard treatments in vogue at that time).  Usually, numbers of subjects involved in Phase 1 trials are very small; possibly from 10 to 20 subjects. In my next posting I shall pass on to the provision of an account of what are known as Phase II trials.


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