Saturday, August 10, 2019

What is Patient Advocacy Patient Engagement and Patient Centricity?


Patient advocacy is not only important to patients, but it is a vital aspect during the entire clinical trial process and all involved.

It is necessary to create mutual trust. Patients got to be confident that his or her best interest is inside.
Patients, patient advocates and alternative stakeholders might act as a negotiator to assist patients better understand the clinical trial, and address queries or considerations concerning additional personal problems.

Patient advocate as someone who helps guide a patient through the screening, diagnosis, treatment, and follow-up of a medical condition, like cancer. A patient advocate helps patients communicate with their health care suppliers
so that they get the data they must create selections regarding their health care
Research program managers, for instance, area unit typically faced with the challenge of balancing the work workers members will manage, whereas still achieving study targets, maintaining knowledge quality and compliance, and sometimes at the highest of the list, staying at intervals budget. Collaborating with patients, patient advocates and alternative stakeholders could prove no-hit in lowering the study work related to patient-centred encounters. Patients, patient advocates and other stakeholders will facilitate in selecting the proper language required for specific patient target teams. clinical trial professionals got to facilitate patients, patient advocates and different stakeholders keep the pace. In the end, the clinical trials and therefore the patients concerned are the beneficiaries typically, patients don't seem to be aware that clinical trials are an option, and if they are doing then the challenge is finding one. Patients, patient advocates and alternative stakeholders will facilitate gather insight within the best ways that by informing patients of clinical trials, and what steps to require to find the ‘right one.

This September 26 – 27, 2019, Researchers, Principal Investigators, Academicians, Business collaborators, Pharmaceutical Companies talk about the importance of Patient Centric Clinical trials at the 2nd International Conference on Clinical trials & Pharmacovigilance which will be held at Prague, Czech Republic.

Submit abstracts to speak, to present posters: http://clinicaltrials.alliedacademies.com/abstract-submission



Contact
Evelyn Itzel
Program Manager Clinical Trials 2019
LinkedIn: Evelyn Itzel

Friday, August 9, 2019

Is Diabetes Uncurable, does metformin actually work?

Join the Dr Sumbul Khalid and Her speaker session.

 Do we need pharmacovigilance of drugs like metformin?

Diabetes Mellitus is an overwhelming medical crisis for Pakistan (ranked 6th globally) with an expected 14.5 million patients by 2025. Type 2 Diabetes Mellitus (T2DM) predominates, with around 90%, of all the reported diabetic cases in Pakistan. Metformin (Glucophage) is the go-to, first-line

drug monotherapy against type 2 Diabetes Mellitus around the world. A global observation is that despite the drug's proper usage, around 35% of T2DM individuals do not succeed to achieve initial optimum glycemic control by metformin monotherapy.

 In this era of personalized medication, it has been established that genetic factors are responsible for 64% to 94% of variations in an individual for renal clearance of any specific drug, including metformin.


They conducted a study to estimate the contribution of genotypic differences among diabetics for their individual Responses to metformin affects. Many SNPs from the genes associated with metformin pharmacokinetics were found associated with these differences. The analyzed genes were SLC22A1, SLC22A2, SLC22A3, SLC47A1 and SLC47A2. We report strong, statistically significant, associations of certain SNPs with the ineffectiveness of metformin in non-responding patients.


Assessment of individual responses (or no responses) of patients to their prescribed drugs come under the umbrella of 'Pharmacovigilance' and it is recommended that medical practitioners all over the world, but particularly in Pakistan, may consider the genotypic evaluation of their patients before prescribing metformin to all the patients, since a good (35%) patients do not respond to metformin.

So, what might be the better medication?

Conference Name: 2nd International Conference on Clinical Trials & Pharmacovigilance
Have your own answers, submit your speech here

Whatsapp: 44 14 03 5820 77
LinkedIn: Evelyn_Itzel
Twitter: @clinical_events

Wednesday, August 7, 2019

What are the challenges in pediatric trials?


Conference: 2nd International Conference on Clinical Trials and Pharmacovigilance
Date: September 26 – 27, 2019
Place: Prague, Czech Republic

Pediatric patients can be divided into several age groups, including pre-term new-borns, full-term new-borns, infants and toddlers, children, and adolescents. It is known that pharmacokinetic (PK) parameters can differ greatly among these subpopulations due to the natural development and maturation of hepatic and renal systems. The issue of pharmacokinetic (PK) variability can be solved by using parameters such as gestational age and weight to predict the variability. The variability in pharmacodynamic (PD) parameters raises more questions with an inadequate understanding of the disease pathology. Population PK/PD (pop/PD) modelling and simulation approaches can be very useful in providing variability information for experimental design, data analysis, and interpretation.


Enrolment DifficultiesPediatric clinical studies rarely enrol healthy volunteers, except for certain studies with minimal or no risk. In most of the studies, Pediatric patients are recruited rather than healthy children. In this scenario, with many Pediatric diseases being rare disorders, getting enough patients enrolled to satisfy statistical requirements is a huge challenge. To make things worse, these rare Pediatric diseases usually do not share similar disease progression with the adult form. Therefore, the easy path of extrapolation from adult studies is invalid, and a full, well-controlled PK/PD study with enough patient is required.

Difficulties in Allocation to Placebo Arm: Use of a placebo control is relatively restricted in Pediatric clinical trial design, as it is often difficult to convince parents/guardians to enrol their child into a study where they may receive a non-efficacious treatment. Outside of certain special circumstances where the use of a placebo control might be justified, standard-of-care treatment is more frequently used as the control in Pediatric clinical trials. The active treatment thus needs to be proved on-inferior, equivalent, or superior to the standard-of-care treatment.

Pediatric drug development is not just drug development for small adults. Indeed, the Pediatric population presents several challenges, from physiological differences to unique study design elements, that must be carefully considered. However, along with these challenges come many opportunities to leverage available data in a way that can expedite development while still ensuring safe and effective treatments for Pediatric patients

Source: Nuventra*
To address this concerning issue, you can submit your ideologies here: Abstract Portal

To know more
Whatsapp: 44 14 03 5820 77
Linked In: Evelyn_Itzel
Twitter: @clinical_events