I am an active reader, follower, trainer and implementer of GCP.
The question i have is: are these guidelines good enough for the developing world setting? When will they get revised to accommodate more of non-pharmaceutical industry led studies?
Hi, maybe the same question could be posed for the WHO Guidelines. ICH are from 1996 and WHO from 1995.... at that time most "big" trials were run by commercial sponsor. So, both Guidelines do not identify specific challenges of independent, externally funded research. I think your question is very relevant: the two main international GCP Guidelines have not been revised for some 15 years. Should a group like this advocate for their update, to make them capture the current scenario and acors in international clinical research?
Can only agree with you. I guess part of the rationale for this forum is to get impressions of what those of us involved in trials are feeling about issues and when the trend is clear, a plan of action can emerge.
I would like to here other views.
The idea is that when we have long discussion topics, like I am sure this one is going to become, we can build an agreed consensus . This consensus will be a single document that brings the points together in an agreed statement and that can then be placed on the articles area of the site, showing all the contributors - with some form of external/expert moderation to ensure quality and credibility. This statement will be open access for anyone to use as they wish, maybe releasing to like the WHO as a powerful consensus view. So for this we need other comments and views, so we all invite and strongly encourage others to comment and I look forward to reading them
Hi Roma! Thanks for raising this important issue about the applicability of ICH-GCP to "small" clinical trials that are being conducted in developing countries. I think the GCP guidelines were meant for pharmaceutical companies conducting "big" clinical trials and are not tailored towards "small" clinical trials sponsored by academic institutions and individuals. Of course, most IRBs and regulatory authorities always require Investigators to follow the ICH-GCP guidelines but I believe the guidelines are irrelevant in some contexts. Think of a University Professor who is sponsored by his University to do a "small" clinical trial on two well-known drugs to find out if drug A is superior to drug B in curing disease C. Is it practical for such an Investigator to follow the ICH-GCP guidelines by the book? I think the ICH-GCP guidelines need to be revised in order to incorporate the different types of clinical trials that are conducted. Just as the different ethical guidelines such as CIOMS and Declaration of Helsinki have gone through several revisions, it's high time the ICH-GCP guidelines were also revised.
This reads in good sound and needs citations to justify our observations. We need to come-up with real challenges for implementing ICH-GCP for small clinical trials. The guidelines are available to those who need to use them, and at any level. If this is not happening, we need to define the challenges. I have noticed that, ICH-GCPs are general. As such, some in-country regulatory authorities/counsels have Good Clinical Research Practice add-ons to take care of their local fine details, not always so in some countries in Africa. I should admit that most national regulatory authorities have just copied ICH-GCP & WHO GCP guidelines, forgetting local sensitivities, cultural norms, community believes and so on. This is made more complicated by the fact that most academic institutions have no idea of ICH- Good Clinical (Research) Practices. As such they can easily do their small clinical trials there under a regulatory authority's nose and never get detected. Students/post-graduates, who do their academic research projects out in the country, at district hospitals, can easily walk through with no GC (Research) P at all. I see three issues here, GC(P)P enforcement, GC(R)P awareness and the issue of appropriateness.
Hi Dears, this debte is really interesting! I would like to add something more.
Medical research, and research on health systems, have always also a kind of "social/ethical impact", especially but not only when they address the needs of vulnerable groups. Such impact is not addressed by the current GCP Guidelines, maybe because they still reflect the scenario of the early '90s. I try to list some potential indicators of such "social and ethical impact of research":
- access to the results of the research for the study population (addressed by the Helsinki Declaration and CIOMS, but not by GCP)
- pertinence of the research for the study population (addressed by the Helsinki Declaration and CIOMS, but not by GCP)
- impact of the research on health facilities (in resource poor contexts): is the research adding -or substracting- resources for the routine clinical activities?
- is the research creating a double standard of care (recruited vs. non recruited patients)? To what extent is this acceptable?
It would be interesting to create such a checklist and propose that such criteria are considered in any upcoming revision of GCP.
i think that apart from just looking at ICH-GCP, we should also take a very close review at the WHO guidelines for implentation in resource limited settings.
there are many other guidelines that adress areas in research that others do not.
I agree that there should be an advocacy for research guidelines especially that govern research in non clinical trial settings.
do researchers that conduct epidemilogical research have the "right" to take "advantage" of participants, just because the research involves no more than miniml risk, thus it excludes them from the stringest laws and regulations that governs clinical trials.
i think more should be done to harmonize and regulate this kind of research , because it is true that humans are used in these kinds of researches and there should be more done to protect those that are involved in these trials.
are these types of studies not contributing to a generalzable knowledge? Dont the people that aprticipate in these types of studies need as much protection and arent these studies also part of what contributes to practise( is some cases)? so why is more not being done?
It is interesting to note that Academia is not governed by regulation and are free to 'plough the field in a way that they fit', while all other form of scientific research is to be bound by a set of regulations?
who contributes more to the generalizable knowledge, is not Academia, is there not a 'publish or die' kind of policy hanging over their heads? is most published articles due to research?
these are just some of the aspects that need to go into review so that there is a more generalizable guideline that takes into account, non Pharma( Non-commercialized) types of research.
I think the ICH-GCP guideline itself is not so much the problem and I advocate that a certain standard (as defined in ICH-GCP) should apply to all at least interventional studies (if not to all clinical research) wherever conducted. The main problem for us are the different interpretations of the guideline. However, I agree that an update of this now about 15 years old guidelines is due and the kind of investigation and risks involved should be considered appropriately. The European Commission planned to come up with a guide for 'academia' when the Directive was implemented, but never finalised it.
It would be good if we could continue to point out which problems we face and make suggestions how that could be changed.
Good to read this discusstion. I am keen to know whether there is any difference between GCP courses and whether there is any rules about who can run courses. There seems to be many different approaches and this is confusing
As far as I understand there are no 'rules' or guidelines on who can run courses and training research staff in ICH-GCP. The accepted practice is that people who have the right experience and qualification should conduct training - I think this is surely the case in most fields? In this situation of clinical research there is a misconception that some form of official training provider is needed, perhaps a training company or an official organisation. This is not the case and it is perfectly good practice for research groups to conduct interanl training using their more experienced staff, or bring in another researcher from another group. It need not be expensive and let us not over regulate. Do others agree with my view on this?
As far I know, GCP courses are supposed to be run by people who are certified to offer such courses. Not every Jim and Jack can train others in GCP! Most Clinical Trial Associates/Clinical Trial Monitors are certified to offer such courses after attending "GCP Trainer of Trainers" courses. However, due to lack of resources and expertise in my home country, I have seen Research Nurses who have attended GCP courses training other Research Nurses in GCP. I wonder whether this is internationally accepted. Certainly, we need certified people to offer such courses!
It is interesting to note that this discussion has proceeded with interesting points of view. But please let me comment on the latest post. Before i proceed, i wish to say that i have conducted clinical trials in developing countries for 12 years now, and i an ACRP certified professional.
I want to cautiously agree that indeed not "every Jim and Jack" can train others in GCP. It is fundamentally true. However, i also wish to say that we need to be careful with the tendency, particularly from our good pharma colleagues to almost create a sense of ownership or superiority to GCP knowledge.
It would be prudent to train GCP trainers, but that does not per se legitimize the issue. There is NO rule in so far as ICH GCP or even WHO GCP is concerned.
I think that there has to be good knowledge and understanding on any subject before one can teach it well. And Training of trainers in itself does not necessarily give the moral right as one can as well question the providers of that training.
Yes, i believe one can train others in GCP even with no certificate as a trainer. The key issue is good understanding of the subject, good experience and knowledgeable view on surrounding issues. And yes a trained Nurse can teach others in GCP so long as they are well versed with the subject.
Most importantly, the critical background to GCP is to ensure that those involved in trials generate credible and quality trial data. I believe this is a balanced view.
Keen to listen to others.
This is very reassuring to read this well qualified response as this indeed was my understanding and interpretation of the guidelines. I agree that training is about experience and knowledge and this misconception about the need for 'certificates' and 'accreditation' is off-putting to the point of being a hinderence. Many well experienced trial coordinators and investigators should be conducting training of their staff and trial teams on site. let us not have them put off this by the perception that they need some expensive peice of paper saying that they are qualified to do this. We are all professionals and should be lead by professional behaviour and standards. What do others say?
Every training should follow the official guidelines regardless of the trainer. And in most cases these guidelines are enough. However sometimes there are local regulations which apply in certain countries which are often missed in the expensive certified GCP training courses. This is the reason why I support the idea that trainings should be conducted by local experienced people involved in clinical trials.