Application of Good Manufacturing Practices (GMP) in Clinical Trials

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Patients who are administered medication, have faith in the medicine while having it. There is a belief of getting cured. The trust lies with the prescribing doctor & the pharmacist; who in turn rely on the manufacturer of the medicine for its quality. No one involved in this chain (neither the patient, the doctor or the pharmacist) can make out, if the medicine is genuine or faulty. To preserve this trust, regulators have bought in guidelines which are known as Good Manufacturing Practices (GMP).

No product by itself or by testing, on its own can ensure its quality. As a lot of testing is destructive; hence only few samples from a batch can be tested. This is called as batch testing.

Good Manufacturing Practices (GMP) ensures the quality of products by its implementation at root levels i.e. in processes and in manufacturing.
This includes not just achieving quality but far more than that. There is a clear and detailed list of specifications on every step involved in manufacturing, for example in the process of materials used, manufacturing, operations, packaging etc. There are standard operating procedures being documented for all the activities like handling, storage, testing etc. The facilities like production units, its premises, manufacturing equipment and staff have to be as per the requirements as well. Continue reading

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Are Placebo Controlled Clinical Trials Justified / Ethical?

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A placebo controlled study is where subjects are randomly assigned to a placebo along with the intervention studied. In case there is no established/available (standard) treatment for a given condition; a placebo control is often the design of choice. However, questions are raised if a treatment is available that is more effective than the placebo. In such situations it is considered unethical to use a placebo without strong justifications, particularly if the illness is life-threatening. The rationale for the use of placebo for effective / standard therapy should be inclusive of the fact that it not expected to cause irreversible health problems or worsen the prevailing condition of patients. In any case, the use of placebo should be jotted with estimated risk for not receiving standard care.

The debate on the use of placebo flared after the announcement of fifth revision of Declaration of Helsinki in the year 2000. The controversy was centered with several issues such as the use of placebo may involve the methodological superiority of placebo-controlled trials in discerning treatment effects. Secondly, it was unclear if the results were mixed with placebo effects or they were confined to treatment-specific effects (excluding placebo effects). Thirdly, risk parameters for placebo groups were questioned. Since then it is much debated and the opinions of researchers are divided on the use of placebo control groups in clinical trials when effective treatment exists. (Woo J 2003) Continue reading

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Regulations & Guidelines of Complementary / Alternative Medicine in South East Asia:

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The evolution of traditional medicine has taken place since thousands of years. This form of medicine has been very dominant in most of parts of South East Asia. In today’s world this form of practicing medicine is called Traditional Medicine or Complementary/Alternative medicine (TM/CAM). TM/CAM is monitored in this region under the regulations of WHO (World Health Organization) South-East Asia Region (SEAR). Many countries from this region have developed extensive systems of Traditional Medicine health services. In many parts of South East Asia, countries such as India, Indonesia, Nepal and Sri Lanka, a large population use traditional medicines to meet their primary health care needs. Given the role of TM along with its rich history, Traditional Medicine and its practitioners have been recognized by the governments and are regulated by national policies which are implemented under WHO (World Health Organization) South-East Asia Region (SEAR).

CAM (Complementary/Alternative Medicine) practitioners include Ayurvedic practitioners, homeopaths, naturopaths, acupuncture and Unani practitioners. These therapies are practiced as ‘Evidence Based’ by these practitioners. They are also used as self-care or as an alternative form of treatment to conventional medicines and hence generate a large market and demand for medicinal plants and herbal products. Due to large base of Traditional Medicine, many countries in SEAR need expertise and guidance to develop national regulations and safety monitoring systems. Continue reading

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Advertising in Clinical Trials

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A clinical trial enrols human volunteers to determine the safety and efficacy of the new or existing drugs or medical devices in different therapeutic conditions, while the subjects well-being and rights are protected. The success of a clinical research project depends upon the subject enrolment and randomization rate. To accelerate and enhance the patient enrolment, certain methods can be adopted, of which, advertising plays an important role in subject recruitment. All advertisements shall be reviewed and approved by the ethics committee before they are made public. Advertisements can be done through newspapers, pamphlets, e-media, etc.

FDA has set some guidelines for advertising the clinical trials for patient recruitment. FDA states that an Institutional Review Board (IRB) is responsible for review and have authority to approve, require modifications in, or disapprove all research activities covered by the IRB regulations [21 CFR 56.109(a)]. It is the Institutional Review Board’s responsibility to review the content in the advertisement and approve it for patient recruitment.

The following elements should be included in an advertisement as per FDA requirements: Continue reading

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Intellectual Property Rights (IPR’s) and its Importance

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In many cultures and scriptures the knowledge about the use of traditional plants was through. This was passed on within families from generations to generations. These were highly nourished but hardly any of it was documented; and if it was written then it was in local languages, which were pretty difficult to interpret. (Biswal M 2003)

This form of un-standardized documentation resulted in conflict in awarding the patents. The owners were not benefitted with rewards instead had a difficulty in proving themselves. This also led to conflicts in conservation of such medical value plants, as the resources were exploited by both the patentee and holders of these valued products. Finally this resulted in endangering such valuable products. Hence the need of establishment of strategies to be followed on intellectual property rights (IPRs) (Biswal M 2003). Continue reading

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Investigator Meeting (IM) in Clinical Trials

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An Investigator Meeting is usually a sponsor’s job, but a CRO may also be delegated with this task. For many from the industry, investigator meeting is much targeted and criticized for overspending. It is argued that these meetings are generally hosted to lure investigators in clinical trials but if we try to understand the need of such events they are much more fruitful than being thought of.

What is an investigator meeting? It is nothing but a group meeting conducted on behalf of sponsor/CROs to train investigators and their lead clinical trial staff on trial related activities, standard operating procedures and to discuss the applicable regulatory picture. The content of an investigator meeting is usually trial specific, nevertheless a common agenda, on SOP’s, Adverse Event Reporting, Source Documentation etc are also discussed. Continue reading

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Clinical Trials using Stem Cells

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Stem cells are unspecialized cells that have ability to self-regenerate and ability to differentiate into other cells. Stem cell technology is being used in treating many diseases those formerly have no treatment, but most of them are in elementary stage. In recent years, clinical trials with stem cells have taken the emerging field in many new directions. The stem cells can be derived from bone marrow, umbilical cord blood, placental, mesenchymal cells etc.

A review article says that there are many studies involving autologous therapies and some allogenic therapies, based on the recovery of mobilized bone marrow cells, including mesenchymal stem cells (MSCs) and adipose derived stem cells that also include the stromal or adherent cell type that has an MSC phenotype. Human umbilical cord blood cells have been used in a large number of trials for paraplegia, ataxia, multiple sclerosis, amyotrophic lateral sclerosis, cerebrovascular disease, multiple system atrophy, motor neuron disease, among other indications, without severe immunological response. Placenta-derived stem cells are being considered for similar uses and are in Phase III clinical trial for critical limb ischemia by Israel’s Pluristem Therapeutics.
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ICH (International Conference on Harmonisation) and its Guidelines:

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We are quite known to the term ICH-GCP and most of us have an understanding that GCP (Good Clinical Practice) are guidelines that have been proposed by ICH for the Clinical Research arena. Let us now focus on the organisation of ICH, which very few of us have tried to explore.

As we all know that all the guidelines came into existence after realizations that were tragedy driven (for example the Thalidomide Tragedy that occurred in Europe in 1960). During 1960-1980, there was urgent need to rationalize and harmonize regulations, which was overshadowed by multiple concerns like over rising costs of health care with the public demands to have safe and effective drugs in the market in the shortest possible time. Continue reading

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Pharmacoepidemiology and pharmacoeconomics

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Pharmacoepidemiology is a sub-discipline of epidemiology which is concerned with evaluating the efficacy, effectiveness and safety of pharmaceutical products while Pharmacoeconomics is branch of health economics which highlight the evaluation of pharmaceutical products in terms of their value for money.

When we observe largely, it seems that the goals of pharmacoepidemiology and pharmacoeconomics are similar of evaluating pharmaceuticals products but on assessing in-depth we find that these streams work in parallel. Practitioners of each discipline work largely in isolation of each other, while the evident logic which seems true in one may also contradict the other.
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Quality of Life (QOL) Clinical Trials

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World Health Organization defines Quality Of Life as ‘individuals’ perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, standards, expectations and concerns”.

Quality Of Life depicts the difference i.e. the gap between the hopes and expectations of a person and their present experience. It is human nature to adapt to life in circumstances in way that will adjust our expectation to lie within the realm of what the individual perceives to be possible. This enables people who have difficult life circumstances to maintain a reasonable Quality Of Life. Continue reading

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