Scientific Review

The Scientific Review Committee

The Scientific Review Committee (SRC) is a critical body within the Barts Cardiovascular Clinical Trials Unit (CVCTU) which ensures the scientific rigor, ethical integrity, and feasibility of clinical trials conducted under its purview. Comprising a multidisciplinary team of experts, the committee is chaired by Professor Amrita Ahluwalia, Dean for Research in Faculty of Medicine and Dentistry, and reviews clinical research protocols before they advance to the next stages of development and implementation. This process helps guarantee that trials are scientifically sound, ethically conducted, and likely to yield meaningful results for both clinical practice and the broader scientific community.

Purpose and Scope

The committee primary objective is to evaluate the scientific merit and methodological rigor of proposed clinical trials within the CVCTU portfolio. In doing so, it plays a pivotal role in safeguarding the validity of research outcomes and ensuring that trials align with the highest standards of clinical research. It also decides whether the CVCTU is the right unit for the study, based on the expertise in the unit and if the unit can provide the right kind of support.

The SRC reviews several key aspects of clinical trial protocols:

1. Scientific Merit: The committee assesses whether the proposed research question is innovative and important within its field, addressing unmet needs or advancing knowledge. It evaluates whether the trial has the potential to generate impactful data, advancing clinical care or contributing to scientific understanding.
2. Methodological Rigor: The committee scrutinizes study designs, including endpoints, sample size, randomization, and statistical analysis plans, ensuring that the methods proposed are capable of answering the research question posed. This includes evaluating the appropriateness of inclusion and exclusion criteria, treatment regimens, and data collection methods.
3. Feasibility: The committee assesses the feasibility of the study within the available resources, timelines, and participant population. This includes evaluating logistical considerations such as recruitment potential, study duration, and site capabilities, ensuring that the study can realistically be completed as designed.
4. Ethical Considerations: The committee complements existing ethical review processes by ensuring that the trial’s design is ethical, particularly regarding risk-benefit assessments, informed consent procedures, and participant safety.

Composition

The committee is composed of a diverse group of professionals, including cardiologists, biostatisticians and clinical pharmacologists. This diversity ensures a holistic review of each protocol, drawing upon a wide range of expertise to assess the scientific, clinical, and ethical dimensions of a proposed study.

- Cardiologists provide insights into the clinical relevance and feasibility of the trial.

- Biostatisticians review the statistical design and ensure that the data analysis plan is robust enough to address the research question.

- Clinical Pharmacologists evaluate drug mechanisms and interactions.

Role in Clinical Research

The committee reviews are an essential step in enhancing the overall quality of clinical research. By rigorously vetting protocols, the committee helps investigators refine their study designs, identify potential issues early on, and improve the likelihood of success. This ensures that resources are allocated to trials with the greatest potential for scientific impact and patient benefit.

Moreover, committee approval often serves as a prerequisite for other regulatory or funding approvals, making its role essential in the broader landscape of clinical research governance.

In summary, the Scientific Review Committee of the CVCTU serves as a critical oversight body that ensures clinical trials are scientifically valid, ethically sound, and feasible. Its work enhances the integrity and quality of clinical research, supporting the mission of advancing medical knowledge and improving patient care.

You can find more information about working with us on this page: https://www.qmul.ac.uk/whri/clinical-activities/cvctu/collaborate/