The modern paradigm of evidence-based healthcare is based on quality research through ethical and well-designed clinical trials. A drug, therapy or medical device has to pass through a series of trial stages before it can be approved for prescribing by medical practitioners. Pertinent to mention in the beginning is the fact that safety, efficacy and pharmacoeconomic data is an ongoing process in the complete life cycle of a drug or medical device with new information accrued during the course, playing a deciding role for continuation of the drug in the market, any change in product label or warnings, or in some cases its withdrawal. Labelling is also a crucial regulatory component focused on by the for medical apparatus. Medical devices, as with any other facilitated apparatus, should be labelled appropriately prior they can be advertised. Appropriate labelling, as stated by the depicts that any materials linked with the device like containers, booklets or other product details should be precise and unbiased. It also should include the complete address of the manufacturing company or distributor. Labelling policies from the also necessitate manufacturers to register other viable functions of the medical device aside from the intended function. You can find here the best labeling company who makes the best quality control stickers.
This brings in the concepts and systems of pharmacovigilance and pharmacoepidemiology which are a vital component of the healthcare enterprise. When someone is serious about breaking free from the grips of medicine , an inpatient drug rehab in South Florida could also be his or her best choice for fulfillment. Being a part of an inpatient drug rehab center means the individual affected by the addiction is being immersed in addiction education, counseling, support groups, and one on one therapy on a day to day. While inpatient drug rehab is usually more intense than outpatient rehab options, studies show that completing a longterm inpatient program can greatly reduce one’s risk of relapsing after rehab is over.
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Nigeria is slowly gaining momentum in clinical trials in Africa. A search made on the US Clinical trials registry clinicaltrials.gov on 26th October retrieved 145 clinical trials. Nigeria also has its own clinical trials registry (nctr.nhrec.net/index.html) with an open access to all ongoing and completed trials.
James Lind Institute (JLI) provides many online courses focussed towards the clinical trials management and allied specialties which may be relevant for the developing clinical research industry in Nigeria. Apart from the mainstream clinical trials management courses are also provided for pharmacovigilance and pharmacoepidemiology, medical and scientific writing, clinical data management, quality assurance, regulatory affairs, medico-marketing, medical journalism, pharmaceutical medicine and translational medicine.
Regional differences in susceptibility to various diseases is multifactorial and includes a complex mix of socioeconomic, cultural, environmental and pharmacogenomic factors which define the response to a causative agent of disease. Understandable a new drug, device or therapy needs to be tested in all major populations of the world to gather information of the differences in response it may have due to these factors. The pharmacogenomic differences to drugs by various populations is by far the major and newer paradigm which is influencing the pharmaceutical industry in developing newer small molecule drugs, biologics or devices.
Clinical Trial Phases
Before a pharmaceutical company proceed to clinical trials, preclinical trials (in vitro and in vivo animal studies) would have been conducted to obtain data that would justify progression to clinical trials. Clinical trials are broadly categorized into four phases.
Phase I
Phase I clinical trials are usually conducted on healthy volunteers. Exceptions to this could be oncology drug trials). The objective is to establish the safety and toxicity profile of the test drug. It is also to study the pharmacokinetics and pharmocodynamics of the drug in humans.
Phase II
Phase II clinical trials involve drug trials with a few number of patients that suffer the disease of interest. The objective is to establish the dose and explore the efficacy of the test drug. Trials are performed by companies like this one here.
Phase III
Phase III clinical trials involve conduct of drug trials with a large number of patients. It is usually an expanded and more focused studies of clinical effectiveness and safety. Drugs are usually registered by regulatory agencies after the phase III clinical data shows efficacy and safety and a favourable risk benefit ratio.
Phase IV
Also called Post-marketing clinical trials. These are a vital component of pharmacoepidemiology and pharmacoeconomic studies. At this phase of clinical trial, drug has been licensed for treatment and its usage is continually monitored for adverse effects.
The Nigerian ‘National Agency for Food & Drug Administration & Control (NAFDAC)
Drug Evaluation & Research (DER) Directorate’ published its revised clinical trials application on the 2nd of July 2018. It states that no person shall commence a clinical trial or cause a
clinical trial to be commenced or conduct a clinical trial, unless the Agency has given a written authorization in relation to the clinical trial. It also states that it is necessary to emphasize that no person shall import, procure or manufacture a drug product, cosmetic or medical device for the purpose of a clinical test in Nigeria unless he is a holder of a valid clinical trial approval and the trial is to be conducted in accordance with the terms of the approval and the provisions of any Regulations in force.
The Nigerian ‘National Agency for Food & Drug Administration & Control (NAFDAC)
Drug Evaluation & Research (DER) Directorate’ has made it mandatory that clinical trials be conducted for the following:
- Clinical trial is mandatory for the following;
- New or relatively new chemical entities or herbal formulations for which safety/efficacy profile has not been determined.
- Drugs for new indications.
- Drugs for new patient population group e.g. Age group and race.
- New combination drug products.
- New dosage schedule/regimen.
- New drug delivery system
- Academic clinical trials
Nigeria has also constituted a National Health Research Ethics Committee (NHREC).
As stated on the NHREC website the mission of the Nigerian ‘National Health Research Ethics Committee’ is to
- Determine guidelines for the functioning of health research ethics committees;
- Register and audit health research ethics committees;
- Set norms and standards for conducting research on humans and animals, including norms and standards for conducting clinical trials;
- Adjudicate in complaints about the functioning of health research ethics committees and hear any complaint by a researcher who believes that he has been discriminated against by a health research ethics committee;
- Refer to the relevant statutory health professional council matters involving the violation or potential violation of an ethical or professional rule by a health care provider;
- Institute such disciplinary action as may be prescribed against any person found to be in violation of any norms and standards, or guidelines, set for the conduct of research under this Act; and
- Advise the Federal Ministry of Health and State Ministries on any ethical issues concerning research.
NHREC can be reached on the number 234-9-523-8367.
Nigeria was admitted into the WHO International Drug Monitoring Programme in 2004. That marked a new era of pharmacovigilance in Nigeria. Pharmacovigilance systems in Nigeria are managed by the National Pharmacovigilance Centre (NPC) situated in the National Agency for Food and Drug Administration and Control (NAFDAC—the drug regulatory agency in Nigeria). NPC serves as a repository for reported adverse drug reactions from health workers and also coordinates with other international groups such as the WHO, US Food and Drug Administration and the European Medicines Agency in improving drug safety in Nigeria. NAFDAC published its latest Good Pharmacovigilance Practice Guidelines in 2016.
NPC puts a special emphasis on participation of the public in ensuring drug safety by propagating the importance of it through various public health programs.
James Lind Institute (JLI) is in a unique and optimized position with specialized trainers available in the wide technical specialties spanning from clinical research to public health. The mix of clinical research and public health specialties for an apt combination to deliver innovatively on the training front for the developing clinical trial and public health infrastructure in Nigeria.