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The role of pharmaceutical products in clinical trials

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Clinical trials are a cornerstone of pharmaceutical development, providing the necessary data to ensure new drugs are safe and effective. Integral to these trials are various types of pharmaceutical products, each serving a distinct purpose in the research process.

Explore the roles of comparator products, biosimilar drugs, concomitant medication, combination therapy and rescue medication in clinical trials.

Comparator products are established in-market registered treatments used as benchmarks to evaluate the efficacy and safety of new investigational drugs. They play a crucial role in comparative clinical trials, where the new drug is tested against the standard treatment rather than a placebo.

  • Importance: Using comparator products allows researchers to determine if the new drug offers any additional benefits over existing treatments. This is especially important in therapeutic areas where effective treatments are already available, and the goal is to improve upon current standards.
  • Challenges: Sourcing comparator products can be challenging due to supply chain complexities, varying international regulations, and ensuring the integrity of the supply. Accurate documentation and robust sourcing strategies are essential to mitigate these challenges.

Biosimilars are made from biologics. While biosimilar drugs are “highly similar” to the already approved biological medicines (also known as reference products), they are not identical to the original biologic drug. This means that biosimilar drugs have significantly higher research and development costs and risks They are used in clinical trials to demonstrate that they are as effective and safe as the original biologics.

  • Importance: Biosimilars can reduce healthcare costs and increase patient access to biological therapies, as they are typically priced lower than the original biologics. In clinical trials, they provide a cost-effective alternative for studying new indications or combinations of treatments.
  • Challenges: Ensuring biosimilars’ quality, safety, and efficacy requires rigorous testing and regulatory approval. Additionally, maintaining the cold chain during transportation and storage is critical due to the sensitive nature of biological products.

Combination therapy involves using more than one medication to treat a single disease or condition. In clinical trials, combination therapies are used to assess the efficacy and safety of using multiple drugs together, compared to monotherapy (using a single drug). This approach is particularly common in treating complex diseases like cancer, HIV, and hypertension, where multiple pathways or mechanisms need to be targeted simultaneously for effective treatment.

  • Importance: Combination therapy can enhance treatment efficacy, reduce drug resistance, and provide synergistic effects, where the combined effect of the drugs is greater than the sum of their individual effects. It is essential for diseases where monotherapy has proven insufficient.
  • Challenges: Developing and testing combination therapies involves additional complexity compared to monotherapy. This includes determining the optimal dosages, understanding drug-to-drug interactions, and managing increased side effects. Regulatory approval for combination therapies can also be more challenging, requiring extensive clinical data to demonstrate both efficacy and safety.

Concomitant medications are additional drugs that patients may take alongside the investigational treatment during a clinical trial. These medications are necessary for managing comorbid conditions or symptoms.

  • Importance: Monitoring concomitant medications is crucial to avoid drug interactions and ensure the safety of trial participants. It helps in understanding the combined effects of multiple drugs and in distinguishing side effects caused by the investigational drug from those of other medications.
  • Challenges: Accurately documenting and managing concomitant medications requires careful planning and robust data management systems. Researchers must consider potential interactions and adjust trial protocols accordingly.

Rescue medications are used in clinical trials to provide immediate relief to participants experiencing severe symptoms or adverse effects. These drugs are not part of the primary treatment being studied but are available as a safety measure.

  • Importance: Including rescue medications ensures that participants receive prompt treatment if their condition worsens, thereby maintaining ethical standards and participant safety. It also helps in maintaining trial integrity by preventing high dropout rates due to adverse effects.
  • Challenges: Determining the appropriate use of rescue medications requires clear protocols and guidelines. Researchers must carefully balance providing necessary relief and not interfering with the study’s primary outcomes.

Conclusion

Clinical trials involve various pharmaceutical products, each playing a crucial role in ensuring the study’s success and the participants’ safety. Comparator products, biosimilar drugs, concomitant medications, and rescue medications are integral components that address different aspects of the clinical trial process. By understanding and effectively managing these elements, researchers can enhance the quality and reliability of clinical trials.

At Akesa, we specialise in sourcing these critical pharmaceutical products, ensuring smooth and efficient clinical trial operations. Contact us to learn more about how we can support your clinical research needs.


About the author

Karen Montgomery-Douglas brings a wealth of experience in clinical trial supply chain management, sharing her knowledge to guide sponsors and contract research organisations through the intricate process of sourcing.

Image by LinkedIn Sales Solution on Unsplash.

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Karen Montgomery-Douglas, Akesa

Karen Montgomery-Douglas

Commercial Development Manager