17th-18th April Important Events By Kandela IAS

17th-18th April Important Events By Kandela IAS

India ‘s clinical trials registry

Introduction

• Speedy approval of Covid-19 vaccines during the pandemic highlighted the importance of clinical trials
• Haste with which some vaccine-related phases were cleared in India raised questions about transparency, safety, and efficacy

Transparency of Clinical Trials

• Clinical trial is transparent if all information is accessible in the public domain
• Clinical Trials Registry-India (CTRI) is a free, online public-record system to register clinical trials in India
• CTRI was launched in July 2007 for voluntary use and mandated for all trials in June 2009
• Any trial using human participants and testing drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational and behavioral treatment, and rehabilitation strategies must be enrolled in the registry
• To register, the trial sponsor needs to make a public declaration, identify investigators, define participant selection criteria, seek Drug Controller’s approval, and receive approval from ethics committees at various trial sites

CTRI’s Recognition

• CTRI is one of 17 public trial registries under the International Clinical Trials Registry Portal
• CTRI is recognized as a primary registry by the World Health Organization

• Transparency in clinical trials is crucial for ensuring the safety and efficacy of medical interventions
• CTRI provides a platform for registering and monitoring clinical trials in India, ensuring transparency and accountability

Problems with CTRI:

1. Missing data – Inconsistent records of enrollment, with only 46% of trials being updated after final enrollment.
2. Classification of type of study – Lack of standardized categories, resulting in over 1,000 atypical categories.
3. Internal consistencies – Trials have been known to have internal inconsistencies, such as filling the wrong type of trial.
4. Confusion over definitions – Inaccurate entries due to confusion over definitions, such as interventional trials being listed as observational trials.
5. Incomplete/non-standard information – Non-standardized information about cities may cause confusion and repetition in the registry.
6. Variations in names and organizations – Registering the correct name of the principal investigator is crucial, but wrong spelling, use of abbreviations, or different surnames can hinder the process.
7. Messy data – Unclear data, such as the same acronym being used for two organizations, can lead to overlap and confusion.

Proposed solutions to overcome it:

1. Adhering to WHO guidelines and accurate registration of trials.
2. Making it mandatory for all clinical trials in India to be registered on CTRI.
3. Improving the inner workings of CTRI to be a more functional primary registry.
4. Improving the amount of information each record provides.
5. Adding a ‘Results’ field to the register.
6. Implementing a data-sharing plan.
7. Providing details of the audit trail.

World Haemophilia Day: raising awareness about a rare blood disorder

Background

• World Hemophilia Day observed on April 17th
• First commemorated by the World Federation of Hemophilia (WFH) in 1989 in memory of Frank Schnabel
• Schnabel dedicated his life to helping those affected by the disease

Theme and Goals for 2023

• Theme for 2023: “Access for All: Prevention of Bleeds as the Global Standard of Care”
• Goal is to increase access to care for better bleeding control
• Aim to persuade policymakers and governments to enhance access to care

Understanding Hemophilia

• Hemophilia is a genetic disorder that affects the body’s ability to form blood clots
• People with haemophilia have deficiencies or abnormalities in certain clotting factors
• Symptoms include prolonged bleeding or spontaneous bleeding into muscles, joints, or organs

Treatment

• Treatment typically involves replacement therapy, which involves infusing clotting factor concentrates into the bloodstream
• Depending on the severity of hemophilia, treatment may be needed regularly to prevent bleeding episodes
• Other treatments may include medications to promote clotting or surgery to repair damage caused by bleeding

Recent Developments

• US regulators approved CSL Behring’s hemophilia B gene therapy, a one-off infusion that frees patients from regular treatments but costs $3.5 million a dose, making it the most expensive medicine in the world
• By administering CSL Behring’s Hemgenix just once, it cut the number of bleeding events expected over the course of a year by 54%
• It also freed 94% of patients from time-consuming and costly infusions of Factor IX, which is currently used to control the potentially deadly condition

Hemophilia in India

• Hemophilia is an inherited condition that causes bleeding for a long time after injury or surgery and painful swelling of the joints either after injury or even without injury
• Hemophilia A (clotting factor VIII deficiency) is more common and occurs in about 1 in 5,000 births in India
• Hemophilia B (factor IX deficiency) is less common and occurs in around 1 in about 20,000 births
• India is estimated to have the second-highest number of hemophilia cases with nearly two lakh cases
• Only 20,000 registered patients for hemophilia in the country, according to the Hemophilia Foundation of India

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