Comparator drugs are required for various reasons in the pharmaceutical industry. A right comparator remains an important participant for various research and development experiments. The researchers spend considerable time to find out the right comparator for their experiments and also try to work out how to obtain the right comparator from the right bonafide source.
The process of choosing the most appropriate comparator for an experiment is not easy and involves consideration of various factors. The methodology to compare the new treatment or intervention being tested in the study with a control or comparator group is referred to as selecting the right comparator sourcing model for a clinical trial. The comparator group acts as a standard against which the new treatment’s efficacy, safety, or other outcomes are measured.
For a clinical trial, choosing the best comparator sourcing model requires taking into account a number of parameters. One can follow these steps to make a sound choice:
- Understand the design of the trial: To begin with, it is important to ensure that one fully comprehends the goals and design of their clinical research program and there is a complete understanding about the study objectives, methodology, the study products, and the target subjects and patient population. The understanding of these key factors drives one’s decision regarding the choice of the comparator and the sourcing model.
2. Specify the Comparator: Comparators are required to assess the merit of the study treatment. Therefore, the comparison between the two interventions such as the test product and the comparator product will be studied. The comparator can be a current standard of care, a placebo, or a different treatment.
3. Analyze Feasibility of procurement of the comparator: Based on the needs of the trial, it is necessary to evaluate the viability of various comparator sourcing approaches. One needs to take into account elements like price, accessibility, legal restrictions, and usefulness. The following are examples of several sourcing models:
- Standard of Care: In some circumstances, the standard of care may be the best comparison. When the current standard treatment is widely accessible and sufficiently meets the research topic, this choice is pertinent.
- Placebo-Controlled: In placebo-controlled studies, the new treatment is contrasted with a placebo, an inert substance. When there is no defined standard of treatment or when it is necessary to assess the placebo effect, this paradigm is appropriate.
- Active Comparator: A currently in-use alternative treatment is referred to as an active comparator. This paradigm contrasts the novel therapy with an already-proven therapy. It is appropriate when there are several treatment options accessible and one wants to assess if the new treatment is superior or not.
- Historical controls: In some cases, historical information from earlier studies or patient registries might be used as a benchmark. When it is impractical or unethical to include a control group in the present experiment, this strategy is employed. However, there are drawbacks to employing historical controls, such as possible bias and a lack of randomization.
- Novel Comparator Sourcing: In some circumstances, creative sourcing strategies, such as the use of artificial controls or real-world, evidence-based comparators, may be taken into account. These methods involve comparing treatments using data from other sources.
4. Regulatory Considerations: Early in the planning phase, consultation with regulatory guidelines and interaction with regulatory authorities is necessary. Make sure the comparator sourcing strategy chosen complies with legal standards and is appropriate for the given indication and jurisdiction.
5. Seek Expert Opinion: Consult with statisticians, clinical trial specialists, and other key opinion leaders to get their advice on the best comparator sourcing strategy. On the basis of their knowledge and experience, they can offer insightful commentary.
6. Contemplate Ethical Implications: Make sure that the comparator source model chosen is ethical. Examine the advantages and disadvantages of each model, including the potential influence on patient safety and well-being.
7. Simulations or pilot studies: Think about performing pilot studies or simulations to evaluate the viability and performance of the selected model, depending on the complexity of the trial design and comparator sourcing model.
8. Document Justification: Finally, include a detailed justification for the chosen comparator sourcing approach in the clinical trial protocol. Justify the decision using scientific, practical, governmental, and ethical factors.
The ultimate objective is to choose a comparator sourcing model that most effectively responds to the research question, ensures scientific validity, upholds ethical standards, and makes it easier to produce trustworthy and significant results for the assessment of the novel treatment or intervention under analysis.
