Harmonized clinical governance regulatory framework for Africa

We need a harmonized clinical governance regulatory framework for Africa. Why or why not? And whose responsibility should it be?

Should African governments and private institutions fold their arms and rely on the major pharmaceutical companies in the industrialized world to develop and implement such frameworks for them? My opinion is a “big no, no”.

Local African community leaders, the national Regulatory Agencies and students in the universities, colleges and nursing schools must form partnerships with foreign national and international healthcare institutions to have this accomplished.

Recall these dreaded historical events that we no longer want anywhere on the planet?:

1.  In a more recent Nigeria v. Pfizer case, it was alleged that Global Pharmaceuticals giant, Pfizer, conducted Trovan vaccine tests on 200 children in Kano, Nigeria, without obtaining informed consent from their parents. Eleven children died in these tests, it was alleged.

o Retrieved from Pfizer settles remaining Nigeria, U.S. Trovan suits.

o Retrieved from Nigeria: Pfizer VS Kano Trovan Victims – U.S.$75 Million Settlement Exposed

2. Tuskegee Syphilis Study (1932-1972)  involving 600 African-American men in Alabama in which case 400 of them were infected with syphilis and they were not made aware of the fact that their wives and children could be infected.

o See also Research at UNLV.edu 

3. During World War II, German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent.

o Also  from Research at UNLV.edu 

4. Thalidomide drug experimentation of the 1950s, where about 12,000 babies had birth defects and deformities during the experimental drug’s use in Europe and in the US. Most of the women were not aware of the fact that this drug was experimental.

o Retrieved from UNLV

Steve Jobs’s Death and e-Clinical Trials

FIRST OF ALL,  I WOULD LIKE TO DEDICATE A FEW “MOMENTS OF SILENCE” IN MEMORY OF APPLE COMPUTER’S CO-FOUNDER, STEVE JOBS (1955-2011).

In recent years, the impact of Information Technology on Clinical Trials has been profound, to say the least. Smart phones are now gaining momentum in the recruitment of clinical trials volunteers.  

Additionally, Smart phones have been used in tracking counterfeit drugs in the developing countries and for pharmacovigilance initiatives (monitoring of post-marketing safety of drugs).

Computer Technology has been dictating the pace for the Regulation of  Biopharmaceutical products in the global healthcare market.

Apple Computer, under the leadership of the late Steve Jobs, has been one of the major players in the e-Clinical and e-Healthcare World. How do you think his death will impact new drug trials worldwide, drug regulations around the world, pharmacovigilance and e-Healthcare in general?

It appears though, that Apple had been very secretive about its technological innovations. Has this hampered innovation in the Technology industry in general and the Health Informatics sector in particular?  Is Apple now going to be more apt to sharing?

How about Apple’s influence in the classrooms? Great impact, very positive. How will Steve Jobs’s death impact all these?

Your take on Steve Jobs’s great loss to human development? How will Steve’s death impact Cancer Research?

We still love you, Steve and we will miss you dearly forever. May the Lord Grant You Eternal Peace!!!

Rest In Peace, Steve Jobs

Steve Jobs’s Passing Away

The Common Rule Redefined?

The United States Health And Human Services has, on July 22, 2011, published for public comments, proposed rule changes for protecting human subjects in medical research. This vision has long been overdue in view of the rapid technological, regulatory and scientific advancements taking place globally.

Whilst the changes under consideration  focus mostly on the domestic front, it is not clear how they will impact the International Compilation of Human Subject Protections and the Office for Human Research Protections (OHRP)’s international outreach initiatives.

This aspect needs to be addressed clearly because it would take out the guesswork from studies done outside the United States where language and culture are big issues. Terminologies need to be clearly defined and allow for proper translations into the local languages in order to help citizens of those nations to make informed decisions prior to participating in human subject research studies.

Comments about the proposed changes will go a long way in bringing about the much-needed improvements while attracting and retaining research volunteers. What is your take on this proposal?

Clinical trial improvements in Africa

With the rising cost of new healthcare products development in the industrialized world, the developing countries of Africa, where the cost of labor is comparatively cheap, are becoming a hub for clinical testing of drugs and medical devices.

The problem, though, is that most of these countries do not have their own national regulations governing the conduct of such trials. It is imperative for African nations to embark on partnerships with foreign countries and international organizations to establish a regulatory framework of international standards for testing new medicinal products on their own soil.

This partnership will benefit both the host country and its foreign partners.

Clinical Trials in Africa

Whilst medical products clinical trials in Africa is becoming the “new African gold”, a number of topics need to be addressed including, but not limited to, language requirements, volunteer compensation, ethical treatment of subjects and infrastructure. What roles are the African Union (AU), private sector personnel and National Governments playing to make these “new gold deposits” sustainable?