cAN CLINICAL TRIALS HELP SAVE LIVES?-2

The importance of clinical trials

Clinical trial refers to any research conducted on human participants or group of people in order to evaluate the effects of a selected intervention. They contribute to the development of new drugs used for treatment but also provide ways of improving diagnosis, recognising symptoms variations, essentially a logical approach to testing the effectiveness of clinical interventions such as: new drugs, vaccines, medical procedures, recovery strategy, dietary plan, diagnostic test, knowledge transmission. Common sense or personal experience has sometimes guided human kind in validating knowledge often shared in anecdotal account of personal experience which can lead to assertion of unfounded or unsubstantiated knowledge. The issue with this approach is the reliance on opinions, doctrines or biased views or possibly insufficiently researched paths to promising knowledge.

On the other hand clinical trials methodically establish facts by testing whatever intervention need to be evaluated on a large scale which provides more satisfactory evidence and can be safely deployed for public use. The key difference is the size of the population, if you were to conclude that 4 out of 5 people responded well to a traditional treatment, you will be tempted to think this is a cure that can be applied to the majority of the population but if you could expand the ratio to 400 in 500 then statistically you can claim 80% of tested population will benefit from this treatment. A parameter important in studies of well known medication such as amoxicillin or pain killers such as paracetamol, codeine, is the statistical confidence of the sample of population tested.To put it simply the more people the stronger is the evidence.

Generally the discovery of new drugs based on clinical trials follow three steps.

  • Step 1

Consists of a minimal test on a very small sample to evaluate the effects and side effects, the best route, the safe dosage etc..

  • Step 2

Armed with initial information at the first step it usually proceeds to an increase of the population tested to the hundred in view to understanding the drug’s action or mechanism and how safe it is.

  • Step 3

Increases the sample to thousands in order to make comparison with exiting treatment or placebo (sugar pill, pill containing no active medication). This stage is very important and the term randomised has its significance here. Comparison is usually operated on two groups, one which receives the new medication tested against another which undergo a placebo testing or receives the standard treatment; both participants are given the same chance to be in either group to minimise bias, this is done by computerized random selection.

Randomised control trial is accepted as the gold standard for providing the best evidence. So doctors refer to textbooks such the British National formulary (BNF) that often recommends more than one evidenced -based treatment option for the same disease, they then make their decisions based on this and previous observations, experience, health journal etc.. It is not new phenomenon that a recommended practice or medication become unadvisable or something of the past, this is often based on serious studies such as RCT which derives effectiveness based on stronger statistical evidence involving testing of sample of above the thousands.

Clinical trial, as much as it has contributed to pharmaceutical progress, is not without risks or ethical concerns. They often require serious investment and important safety procedures in order to minimise the risks and increase chance of discovery of new treatment. It is not surprising individuals or companies have sometimes been found to influence production or promotion of a particular intervention or medication to suit their financial goals at the expense of members of the public. However RCT clinical trial hold a promise for devastating diseases such as Covid-19, HIV, Malaria, etc.. therefore should continue to support challenging area of clinical treatments.

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