When it comes to Phase III randomized controlled studies, they can and do sometimes lead directly into areas of real and great concern for patients and their families. “Am I going to be a guinea pig?” is a thought and a question not far, I guess, from the surface of most patients’ minds when approached about the possibility of entering such a clinical trial. Well let me promptly respond directly to this; and there are several key points needing to be made.
First and foremost (and as already stressed above) proof about treatment or drug A, as opposed to drug B, has yet to be determined – either way – since that is the whole point and purpose of the trial. Second, any such study carried out in the NHS, can only proceed on the basis of successful negotiation of Phase I and Phase II trials and is subject to a carefully prepared (and vetted) protocol. The terms set out in this key document must be rigorously adhered to throughout. Thirdly, other safeguards are now being included in many current clinical trials relating to a wide range of other variables and parameters- these include the physical as well as social, psychological, sexual etc. Finally, you or any other patient will only be included in such a study if you satisfy all of the inclusion criteria and ‘score’ on none of the exclusion criteria for the study.
All potential participants will therefore be properly and adequately informed about every aspect of the study, in so far as it concerns them as a patient. That is why “informed consent” is required in every case and is called what it is. You may rest totally assured that if in the expert and considered judgment of those best placed to decide that your inclusion in the research study might be detrimental or in any way harmful, you are unlikely to even be approached on the matter.
Sometimes in my experience, people respond on the basis: “If it doesn’t help me it might help someone further along the line”. Of course, this might well be one of those instances, which we see from time to time, of patient altruism. Then again, it could also be a straightforward rationalization on the part of someone who has consented to participate but who is still not quite sure about the wisdom of their decision. Should you decline the invitation to participate, then – again, in my experience – no one will ever think the worse of you; nor will it in anyway adversely affect consideration being given to the overall quality of your future care and management within the hospital department.
The simple and self-evident truth is that without such properly constituted and painstaking research, better and more advanced treatment strategies and approaches will never be forthcoming. Come to think of it, trusting your consultant’s judgment in matters concerning your possible involvement or otherwise in research, is really no different to trusting his/her judgment on issues concerning your treatment; and it helps to remember that he/she is where they are because of their hard-won skill and experience in both. Try to remember too, when for some reason you or some other patient doesn’t match the criteria for inclusion in a study, that that is simply the way in which science works. There really is only one kind of science, namely good science; and good science must surely, inevitably make for good treatment, i.e. treatment of the very highest standard.