GCP-Related Laws, Guidance, & Standard Operating Procedures

The Need for GCP to be Linked with SOP, Regulations, and Guidance

The need for GCP to be linked with SOP, regulations, and guidance has been long recognized. Since the 1970s GCP has become a dominate link between clinical research practices and regulations. The following report provides an overview of the universal nature of GCP and the consequences of it not being implemented.

While there is an enormous amount of literature concerning good clinical practices (GCP), there is also a great deal of congruence between the regulations, guidance, and SOP. When one looks at the regulations that enforce clinical practice it is easy to see the problem this congruence. For example, the FDA has designed its guidelines and regulations to be in line with GCP. In fact, the FDA recently redesigned its website such that regulations, guidance, and SOP are directly connected. SOCRA has been an important feature in unifying GCP with regulations and SOP.

The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. SOCRA, the premier educational organization for oncology site coordinators, has now emerged as a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia.

Since incorporation in 1991, SOCRA has been through many changes, all of which were important contributors to our growth...The unification of GCP has been nearly universal in the US and in other developed countries. The need for linking GCP has been born out of the clinical trial process in which it is imperative to establish standards for safety and effectiveness of drugs and medical devices. This universal need has led to the creation of the World Health Organization’s (WHO), handbook, “Guidelines for good clinical practice (GCP) for trials on pharmaceutical products"... (SOCRA, 2015).

The need for this handbook can be seen most glaringly in situations in which it is not being used. Sadly, in many underdeveloped nations regulations and clinical SOP are not effectively linked with GCP. Incidents reflecting poor GCP can be seen such as in Kano, Nigeria where 200 children took part in trials for the new anti meningitis drug in 1996 (Washington Post, 2007). Officials in Kano, Nigeria say more than 50 children died in the experiment, while many others developed mental and physical deformities (Washington Post, 2007). It is alleged that the Nigerian government knew that Pfizer was conducting drug experiments on the Kano citizens but kept this information from the citizens, who are mostly illiterate and would not have known otherwise. Also, the government waited over a decade to file suit against Pfizer, stating that they were slow to file charges because the details of the 1996 drug trials were hard to get from Pfizer (Washington Post, 2007).

This situation highlights the need for laws, SOP, and guidance to be aligned with GCP. Had the laws in Nigeria been aligned with GCP this incident may not have occurred. As well, had Pfizer been following GCP correctly it would not still be enduring a decade long litigation.

References

SOCRA. (2015). Mission and Introduction. Retrieved from Society of Clinical Research Associates (SOCRA): http://www.socra.org/about/mission-and-introduction/

Washington Post. (2007, August). Pfizer facing four Court cases in Nigeria. Retrieved from Washington Post: www.washingtonpost.com