I start my article by saying ‘Ushitasha mwana bwa ndoshi’ (He who is not grateful is a witch’s child). This is because I want to say thank you for the engagement readers of this column continue to give. It is inspiring that indeed people are hungry for knowledge and want to help themselves. Next I will say ‘Umwana ashenda atasha nina ukunaya’ (A child who does travel/visit thinks only his mother can cook a very good meal). The reason I say this is not only about the physical travelling of getting into an aeroplane across the oceans, but the actual exploration of one’s world even through reading about issues. With the Internet, one can get exposed to so much information and you must remember don’t read the one sided story, read wide. It is all there. I am often amazed, when at times I need to research on a particular point of discussion how everything is out there. Someone somewhere has already done some work in a certain scope.
Today I will delve into a topic that most people have apprehensions about but in actual fact may be beneficial. If you recall I have speaking about ethics here and there. So today is the day you take out that book and turn to the definitions on the topic. I will also try to define certain basic processes that you should be offered if you are in a legitimate clinical trial. It is very important for you to understand this as you will often hear a doctor say ‘there is no evidence to back this and that’ especially for herbal supplements. I’m smiling and so should you because it’s good for you! You may learn to respect what that statement means when medical personnel use it as each drug or intervention used go through a rigorous process. A common phrase I hear people use is ‘they are doing experiments on us’. After this article I hope you will understand that ‘experiment’ days in clinical medicine are over due to the stringent processes that exist.
Let us start. A good definition is found in the National Institute of Health’s literature, which states clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. Sometimes it may involve using a totally new drug or intervention at times it may involve using a new pathway or sequence in treatments that already exist.
If an intervention is totally new, after pre-clinical testing, it passes through phases I-III and sometimes IV. Preclinical testing uses laboratories involving human cells or animals. When this is successful the process moves to Phase 0/I of clinical trial and this involves testing an intervention or drug in healthy individuals (volunteers) making sure that the drug acts the way it should and which dose can be given safely and how best to give this drug whether by mouth or injection and so on. It is restricted to a small number of individuals such as twenty. Three quarters of potential interventions and drugs move on to the next stage.
Phase II has several hundred of people taking part after the safety and dose has been established and the drug or intervention is given to people with the target illness like cancer. With the information gathered here, doctors or scientists are able to come up with ways to test the drug better to establish a standard if this is feasible. Only a third of drugs and interventions make the criteria to move on to the next stage.
Phase III studies should include a lot of patients in the thousands to represent a good number for each diverse scenario of a disease process. Previously older individuals were excluded from these trials but doctors are finding it is a problem as people live longer than ages in the trials what do you do with them? As such the current trend is to include them more. At this stage a proposed intervention or drug is tested against the current ‘gold’ standard. This is where most of you, if need be, would find yourselves participating.
Phase IV is called post marketing and actually tests how the new drug or intervention is doing in the real world without the controlled environment of a clinical trial. In essence the product is approved and long term safety and other improvements can be made.
Now let’s start with flags that you must note before participating in a trial. Before any of the phases can take off the investigators must present their intention to an institutional review board and ethics committee. These groups of people make sure that there is an absolute benefit to patients and that their rights are protected.
Flag 2 the medical personnel must explain to you the whole process and you must sign a paper called a consent form in a language that you understand the best. This is very important as it tests of how good the two boards mentioned above are. No person should be asked to participate in a trial without understanding the information fully. So all research document information must be available in all local languages and a good board should ensure this.
Flag 3 you must not be paid enormous amounts of money to participate in clinical trials. The program should, however, cover the basic costs for example transport to and from the treatments or doctors’ consultation and any blood tests required. There is a term in ethics called benevolence, which means the quality of being well meaning and kind. The clinical trial should be draped with this. The scientist or clinician should have the good intentions of the patients at heart and the drive for investigation should be patient oriented.
The benefit of clinical trials is that they allow us to set the best standard of care for our patients, and in cancer medicine with the emerging data on genetic variation and microbiomes, their influence even on interventions like radiation you want to prove their efficacy in our own populations. Another benefit of participating in phase III trials is that due to the rigorous observation your personal face time with experienced doctors actually increases.
The downside of it is it may require you to fill out a lot of paperwork and for some people the extra visits to the doctor’s office is daunting. Another downside is you can’t really choose which intervention you will get whether it’s the proposed one or the standard due to a process called randomization, but when one treatment fails you are switched to the alternative. Whether you remain on trial protocol depends on the design but quality care continues.
So next time a doctor asks you for participation in a clinical trial don’t run out of the office screaming experiment. Instead get the full information, go and dust the cut out of this article from that special drawer (I’m winking at you) and make an informed decision. Remember ‘umwana ashenda atasha nina ukunaya’. Have a blessed last week of September!