What Does a Comprehensive Clinical Trial Package Include?

Clinical trials are an essential step in the development of pharmaceuticals and medical treatment methods. In Vietnam, the Academy of Medical Sciences plays a pivotal role in conducting clinical trials with professional, transparent processes that adhere to international standards. This article provides a detailed overview of the components included in a comprehensive clinical trial package at the Academy of Medical Sciences.

1. Consultation and Design of the Clinical Trial Plan

1.1. Preclinical Research and Goal Identification

Before beginning clinical trials, the Academy’s experts conduct assessments of preclinical research results, including:

  • Effectiveness and safety data from animal studies.
  • Chemical, pharmacological, and pharmacokinetic data.
  • Specific objectives for the clinical trial.

1.2. Development of the Study Protocol

The study protocol is a core document that clearly outlines the objectives, methodologies, and evaluation criteria for the trial. The Academy assists with:

  • Creating a detailed protocol tailored to the study product.
  • Ensuring the protocol complies with ICH-GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice).

1.3. Feasibility Study

The team conducts a feasibility analysis, including:

  • Resource evaluation: personnel, facilities, and technology.
  • Identifying suitable trial locations.
  • Assessing financial and timeline feasibility.

2. Legal Procedures and Approvals

2.1. Preparation of Clinical Trial Application Documents

A complete application dossier includes:

  • Approved study protocol.
  • Product information documents for the trial.
  • Informed consent forms for participants.
  • Risk assessment reports and control measures.

2.2. Securing Approvals from Regulatory Authorities

The Academy liaises with:

  • The National Ethics Committee in Biomedical Research.
  • The Ministry of Health and other relevant agencies to ensure proper approval.

2.3. Adherence to Ethical Guidelines

The Academy ensures all trials respect the rights and safety of participants and comply with medical ethics principles and Vietnamese law.

3. Recruitment and Management of Volunteers

3.1. Developing Recruitment Criteria

Clear criteria are established, including:

  • Health status, age, and gender.
  • Medical history and allergies.
  • Ability to comply with study requirements.

3.2. Volunteer Recruitment Process

This process involves several steps:

  • Recruitment announcements through media channels.
  • Conducting screening to assess health conditions.
  • Explaining the benefits and risks to volunteers before obtaining their informed consent.

3.3. Volunteer Management and Monitoring

Throughout the trial, the Academy:

  • Conducts regular health check-ups and collects data from participants.
  • Ensures privacy and safety are maintained.

4. Execution of the Clinical Trial

4.1. Implementation of Trial Phases

The Academy conducts all trial phases comprehensively:

  • Phase I: Assessing safety and dosage in a small group of healthy volunteers.
  • Phase II: Evaluating efficacy and further assessing safety in a group of patients.
  • Phase III: Comparing efficacy with existing treatments on a larger scale.
  • Phase IV: Post-market surveillance of the product.

4.2. Data Collection and Management

Data is collected through:

  • Electronic medical records.
  • Clinical data management systems.
  • On-site and remote monitoring to ensure accuracy.

5. Data Analysis and Reporting

5.1. Clinical Data Analysis

The Academy’s statistical team uses advanced software to analyze:

  • The effectiveness of the trial product.
  • Types and rates of adverse effects.
  • Comparative results with control groups (if applicable).

5.2. Preparation of Trial Reports

Detailed reports include:

  • Description of methods and results.
  • Safety and efficacy evaluation.
  • Recommendations for improvements or further development.

6. Quality Assurance and International Compliance

6.1. Internal Monitoring

The Academy’s professional monitoring team ensures:

  • Regular checks of trial processes.
  • All activities comply with ICH-GCP guidelines.

6.2. Independent Audits

Independent oversight agencies are invited to evaluate results to ensure transparency.

6.3. Training for Trial Personnel

Personnel are thoroughly trained to enhance their skills and awareness of the trial process.

7. Post-Trial: Product Commercialization

7.1. Post-Trial Monitoring

Even after the trial concludes, the Academy continues to monitor:

  • The product’s effectiveness and safety on a larger scale.
  • Feedback from users.

7.2. Strategic Commercialization Consulting

The Academy’s experts provide advice on building effective market access strategies, including:

  • Pricing strategies.
  • Distribution and marketing plans.

Conclusion

A comprehensive clinical trial package at the Academy of Medical Sciences ensures thoroughness from planning, execution, to data analysis, while meeting stringent international standards. With a team of experienced professionals and modern facilities, the Academy has been pivotal in advancing Vietnam’s medical research to new heights.

Choosing the Academy of Medical Sciences as a partner for clinical trials is a strategic decision that delivers sustainable value not only for businesses and research organizations but also for patients and the global healthcare sector.

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Address: 137 Go Dau, Tan Quy Ward, Tan Phu District, Ho Chi Minh City. Registration Number: 545/ĐK-KHCN issued by the Department of Science and Technology of Ho Chi Minh City on 05/12/2023.