CRITERIA TO INCLUDE IN PEDIATRICS CLINICAL TRIAL

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CRITERIA TO INCLUDE IN PEDIATRICS  CLINICAL TRIAL

WHY SHOULD WE PERFORM CLINICAL TRIAL IN PEDIATRICS? 

Pediatrics  are a singular population with distinct developmental and physiological differences from adults. Clinical trials in Paediatrics are essential to develop age-specific, empirically-verified therapies and interventions to figure out and improve the only medical treatment available.

ETHICAL CONSIDERATIONS:

Before conducting a children’s clinical trial, it is mandatory to take informed consent from their parents or assent should be taken if the child age is more than seven years. It is difficult to take consent of a diseased, underage and poor parents or legally accepted representatives. In emergency situations such as eclampsia, predelivery consent is taken. Sometimes ethical question may arise in clinical trial of very sick children, whether to put them on standard clinical care or clinical trial. Taking an appropriate decision is worthwhile. There is also a question regarding the use of contraceptives and history of illicit drug intake in adolescent children.

IMPORTANCES OF INFORMED CONSENT FORM: 

Children under the age of 18 aren't permitted to offer consent for medical procedures and coverings. Parents are typically the first decision-makers for his or her children. Parents give permission for his or her child to undergo procedures and coverings. The parent giving consent must be deemed competent- in other words, be ready to understand the knowledge being presented.

ASSENT:

In paediatrics, children who are sufficiently old to know medical discussions are sometimes asked to offer assent for care. Assent means the kid is agreeing to the treatment or procedure. Children also can dissent, which suggests they are doing not comply with participate. The age at which assent is requested varies by institution and may be as young as 7 years old. Assent isn't required by law, but many institutions require children who are developmentally and cognitively able, to participate in deciding. You’ll invite assistance in assessing your child’s ability to offer assent from paediatric social workers, psychologists, and child life specialists.

INFORMED CONSTENT DOCUMENT:

The parents providing consent are going to be asked to sign a consent document for every procedure, treatment, or clinical test. Review the document and ask any questions before sign. This type is to guard autonomy (decision making ability) and to verify that you simply haven't been forced to receive any treatment or procedure. They may want to ask for a copy of the form after you have sign it.    

              

TYPES OF PAYMENTS ASSOCIATED WITH RESEARCH PARTICIPATION

Wendler and colleagues (2002) have distinguished four sorts of payment associated with participation in research:

 Reimbursements for expenses (e.g., parking or bus fare)

 Compensation for the time and inconvenience involved in research participation (e.g., payment at wage for a few or all of the hours required of a search participant)

 Appreciation payments at token levels (e.g., $25, toys, gift certificates, or movie coupons); and

 Incentive payments that provide amounts for participation in research that aren't limited to reimbursement, compensation, or token levels

CHALLENGES IN PEDIATRIC CLINICAL TRIAL

                                                                               

PRACTICAL CONSIDERATION IN PEDIATRICS  CLINICAL TRIAL:

• It is necessary to make sure that the participant’s experiencesin clinical trials are positive with less discomfort and distress. 

• Pediatric clinical trials should be carried out in a well-planned manner with complete information given to the oldsters . 

• Trials should be conducted during a familiar environment like hospital or clinic, where the pediatric study participants normally receive their medical care. 

• Topical anesthesia should be used whenever needed and indwelling catheters placed to avoid repeated venepuncture for blood sampling.

• Frequency and volume of blood sampling must be prespecified within the clinical study protocol. 

• The study should be planned in such how in order that it's going to not interfere with the child’s routine activities like sleep and feeding.

• Adolescent children should be happy to ask any question with reference to the conduct of the study as sometimes they'll not accept as true with their parents and would not participate within the pediatric clinical test .

CONCLUSION:

Childrens  clinical trials are vital for studying new drugs as well as designing rational and effective therapeutic regimens in children. Children should be viewed as a separate population entity and not as mini-adults. The unique pathophysiology and pharmacology of pediatric population should be considered while designing pediatric clinical trials. There are multiple ethical and practical challenges of completing clinical trials in pediatrics. Understanding these needs, concerns and addressing these challenges will pave the way for more clinical research in some key therapeutic areas for children.

                                                                                                                

     Written by:

                                                                                                                        .                                   Rafiya fatima  

  Pharm-D intern.