Good Clinical Practice (GCP) is a set of international standards meant for entities that conduct clinical trials. This set of standards, formulated by the International Conference on Harmonization (ICH), when implemented into clinical trials involving human subjects, seeks to ensure the protection of the humans involved in the research, as well as to bring about transparency in the methods of clinical practice. The efficacy and safety of the clinical product these trials seek to produce is another of the desired outcomes of GCP. GCP has been formulated to set standards and protocols that ensure the efficacy of the therapies into a larger population. The most important aim of GCP is to ensure that the data clinical trials generate, in meeting scientific standards, are:
- Accurate
- Verifiable
Now, the challenges associated with GCP implementation
The intention behind the formation of GCP guidelines is beyond suspicion. No person in his or her right mind can argue about the beneficial intent of these guidelines. This said, there are a few challenges associated with GCP implementation. A look at some of the things nobody tells you about GCP before you get started:
Interpretation of the documents
The first important aspect of GCP nobody tells you about pertains to interpretation. This is at the heart of challenges concerning GCP. Good Clinical Practice is an exact science whose practice is open to subjectivity. This is one of the major oxymoronic aspects of GCP. This is because while GCP sets out the standards that clinical sites are required to comply with; it does not state which method to adapt. These standards are codified and located in multiple locations of the GCP standard, which means that those involved in research have to tome over absolutely every bit of the standard before getting down to researching.
As a first step, in the US, the clinical site starting the research has to obtain clearance for this research by signing what is called Form 1572, which is an FDA form in which the investigator has to state all the intent, scope, SOPs, and all other such aspects of the trial. To do this, the Principal Investigator (PI) should read the document upside down, in a manner of speaking, because this is the clearest guideline to what the research is going to do. Although not impossible or unachievable, this aspect of clinical trials is a challenge nevertheless.
Literature review
Literature review is another tough nut to crack for ensuring GCP adherence. This is so because although it appears more like just a formality, sufficient midnight oil has to be burnt to produce a literature review that meets the GCP expectations of the regulatory authorities. All the details of GCP guidelines laid out by such international standards and declarations as the Helsinki Declaration, the Common Rule, the Belmont Report, the World Health Organization guidelines on best clinical practices, and the various CFRs issued by the FDA, have to be taken into consideration. Again, this is something PIs get assistance to carrying out, but is a challenge no doubt.
Getting the site awarded
The actual way in which the recruitment of volunteers, or subjects as they are called, takes place is another of the many things nobody tells you about GCP. It starts with filling up the Investigator Interest Questionnaire. A synonym for a feasibility survey, this is a form from which the clinical research sites are allocated for study. Although done online, this is quite an elaborate procedure, to which one needs quite a high level of understanding of how the system works.
A site qualification visit that follows next is also a critical meeting that the Principal Investigator has with the Clinical Research Associate. At this meeting, all the ingredients that go into the clinical research, such as the purpose and the product that is sought to be obtained, the demography of the subjects, the state and fitness of the instruments, the mode of the trial, the infrastructure of the site and a million other questions have to be satisfactorily answered. It is only following all these that the CRA makes up her mind about awarding the clinical site to the organization.
There are challenges, but don’t let them deter you
It needs mentioning that these challenges are not universal in nature. What is a problem in one jurisdiction or GCP site need not be so in another. Another important aspect that needs to be taken into consideration is the fact that these are not stumbling blocks, but steps aimed at ensuring that the purpose for which GCP was enacted is being met at every clinical trial. So, this should not put anyone off.
These things that nobody tells you about Good Clinical Practice are not meant to scare you from carrying out research which could prove beneficial in many ways, but to just let you know that there are some factors that need to be taken into consideration before plunging into a clinical research.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2794015/
https://gh.bmj.com/content/bmjgh/1/3/e000122.full.pdf
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