The world is waiting, use sequential analysis and get us the evidence-based treatment we need for COVID-19

In spite of the relatively high morbidity and mortality, there is no approved medication yet for COVID-19. There are more than 200 ongoing trials on different drugs or vaccines, but new medications may take until 2021 to develop. Defining the optimal number of patients to be included in a study is a considerable challenge in these interventional researches. Ethical considerations prompt researchers to minimize the number of patients included in a trial. This gains particular importance when the disease is rare or lethal which is particularly so in the case of COVID-19. It is of paramount importance to explore some of the available tools that could help accelerate the adoption of any or some of the many proposed modalities for the treatment of diseases. These tools should be effective, yet efficient, for rapid testing of such treatments. Sequential analysis has not been frequently used in many clinical trials where it should have been used. None of the authors in published literature, as far as we know, used sequential analysis techniques to test potential drugs for COVID-19. In addition to its usefulness when the results of new forms of treatment are quickly needed, other important benefit of sequential analysis includes the ability to reach a similar conclusion about the utility of a new drug without unduly exposing more patients to the side effect of the old drug, in particularly, for the treatment of a rare disease

Identification of Interaction Tests of Predictive Biomarkers in Cancer Clinical Trials

Predictive biomarkers are covariates that interact with treatment in relation to the outcome and thus; predictive biomarkers are characterized by interactions between the treatment and covariates. Many questions remain unanswered in this topic: What is the best design for detecting and validating a predictive biomarker? What can be the sample size required? What could be the statistical methods used to identify those interactions? The major problem of interaction tests is that they lack power; so that a very large trial would be required for the test to reach significance. The identification of a predictive factor becomes difficult if interactions of higher orders have to be investigated. We discussed the use of Martingale residuals combined with the classification and regression trees (CART) to identify which could be the optimal cut point in a continuous marker through data simulation. Our findings using these methods were very close to the expected results given the parameters of the simulation. Our conclusion is that the CART applied to Martingale residuals can be the good alternative of identifying predictive biomarkers. In practice we may need a cut point for a predictive biomarker so that we can know who among patients can benefit from the treatment and those who may be harmed by the treatment; especially when drugs are highly toxic

Enrolment and Retention of African Women in Biomedical Research: The Challenges

In Africa; women have had minimal participation in biomedical research especially in clinical trials despite the epidemiologic realities of the trends and burden of diseases in the continent. The purpose of this paper is to critically examine the challenges as well as suggesting ways of over-coming them in recruiting and retaining African women in biomedical research. Relevant biomedical research literatures on Human Research Participants from Scirus; Pubmed and Medline computerized search were critically evaluated and highlighted. Information was also obtained from research ethics training as well as texts and journals in the medical libraries of the research ethics departments of the Universities of Pretoria; Kwazulu-Natal; Johns Hopkins Berman Institute of Bioethics Baltimore and Kennedy Institute of Bioethics Georgetown University; Washington DC. Studies reviewed have shown that African women have an unfair participation in biomedical research. Efforts in enrolling and retaining women in biomedical research are hampered by chain reactions of events viz: gender perception; cultural barriers; ignorance and fear of adverse event; limited autonomy to give consent; lack of confidentiality especially in sensitive trials; and improper research design. Women need to participate in clinical trials because of their different biological and physiological make-up which require proper information about the effects of drugs on their bodies. A variety of harm may therefore ensue from failure to include adequate numbers of women in biomedical research such as exposure to ineffective treatment; occurrence of unexpected sideeffects and delayed diagnosis and early treatment of disease

Essai clinique du centrum (R) en consultation externe au centre neuropsychopathologique de l'Universite de Kinshasa au Zaire

L'Inadaptation socio-professionnelle est l'une des caracteristiques principales de la population urbaine des pays en voie de developpement. Elle entraine chez les victimes une panoplie de plaintes subjectives de l'insuffisance des fonctions superieures ou predominent les dysmenies; les troubles de l'attention et de la concentration; et le tout avec souvent une connotation anxiodepressive mineure rapidement masquee par des plaintes somatiques multiples. Dans ctte etude; les auteurs constatent dans une population de 55 malades; l'efficacite du Centrum (R) sur certains tableaux cliniques temoins d'un depassement de leur capacite cerebrale. Il relevent en outre l'innocuite du produit. Durant les 3 mois d'experimentation; 65;3des malades sous Centrum (R) seul; ont connu la resolution totale de leurs plaintes intellectuelles contre 86;2chez des patients ayant recu le Centrum (R) associe aux tranquillisants ou a des antidepresseurs; temoins d'une forte somatisation avec une composante anxieuse ou depressive

Analyse clinique du traitement du plasmodium falciparum a l'artesunate

Depuis le mois de decembre 1992; les auteurs ont traite 30 malades atteints de paludisme a plasmodium falciparum par l'artesunate en perfusion; en comparaison avec un autre groupe de malades qui; cette fois; ont ete traites par du quinimax en perfusion egalement. De part et d'autre ces groupes de malades ont supporte le traitement pendant 3 jours. Les malades soumis a l'artesunate ont eu chacun une dose totale de 240 mg. Ceux soumis au quinimax ont eu chacun 2400 mg au total. Le temps moyen de l'artesunate pour faire baisser la temperature et eliminer le plasmodium est plus court et plus rapide que celui du quinimax. Le taux de recidive avec l'artesunate est tres faible et les effets secondaires sont pratiquement rares. Il est vrai que c'est un nouveau medicament; mais nos observations montrent deja qu'il est d'une tres bonne qualite; tres efficace comme antipaludeen; et que les praticiens peuvent l'utiliser sans crainte pour le moment

Le developpement de la recherche clinique en medecine traditionnelle

Quelles que soient les modalites d'application pratique; l'experimentation clinique; dans son essence; est une approche scientifique necessaire a une bonne connaissance et a une evaluation pertinente des vertus therapeutiques des medications traditionnelles. Elle offre sans conteste des garanties objectives de securite; de qualite et d'efficacite quant a leur utilisation dans les soins de sante primaires. Telle est la raison fondamentale de ce travail consacre principalement a la revue des essais cliniques et a leur orientation en fonction des objectifs specifiques des chercheurs