Over the last five years, there has been a major concern within the pharmaceutical industry relating to the rising costs of research and development, along with a reduced number of new drugs introduced into the market. To deal with these issues, adaptive clinical trial designs are being increasingly used to save both time and money and also to facilitate effective decision making.
One of the main challenges faced by pharmaceutical companies today is to deliver compliant clinical trials supplies across different patient populations in the comparatively short timeframes required by adaptive trial designs, and to ensure that product quality and patient compliance is not compromised. This demand has resulted in the introduction of rapid response services that allow research and development to respond to varying dosing regimens mid-trial.
Current Challenges in Adaptive Clinical Trials
In adaptive clinical trials, sponsors use interim data analysis to constantly re-assess their methodology. This often results in considerable changes being made to the study as it advances. Modifications mostly comprise of making changes to the dosage level of a specific drug. Investigations take place under extremely tight timelines and thus only last minute decisions can be made on dosage levels during each phase.
It is important that pharmaceutical companies must be able to meet the demand for new dosing combinations rapidly, precisely and in accordance with regulations. Since new formulations take up considerable amount of time, study directors require new means of defining a dose without re-formulating each time.
Another major issue in adaptive trials is to ensure efficient distribution of materials. For instance, compliant deliveries of investigational products to various study sites present a significant challenge. Hence, there is a need to make sure that Current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and the revised Good Distribution Practice (GDP) guidelines are followed.
Another critical part of this process is to make sure that the drug is tracked throughout the clinical trial life cycle. There is also a need to ensure that there is an efficient and dependable accountability process, so that any product which is not used can be returned and destroyed.
Earlier in 2004, a Strategic Path Initiative was introduced by the United States’ Food and Drug Administration (FDA) to modify the way drugs are made and introduced into the market. This initiative is aimed at dealing with the high levels of attrition observed in the clinical phase of development. It will also provide flexibility to investigators to find the optimal clinical benefit of the medicine being investigated without affecting the validity of the study. A plan that falls under this initiative is the implementation of adaptive design clinical trials.
Benefits of Adaptive Clinical Trials
Adaptive clinical trials are increasingly becoming an important aspect within the research and development field. If used correctly, adaptive clinical trials could save both costs and time by eliminating the number of study failures.
Clinical trials designed with adaptive features can potentially result in more efficient decision-making within a drug development program, and provide a greater chance of responding to the clinical question of interest. Also, since the design allows investigators to assess results on a real-time basis, changes can be easily made to enhance the probability of a positive result.
Clinical Trials Packaging/Drug Supply Challenges in Adaptive Trials
In spite of the efficiency benefits and clear flexibility of utilizing adaptive study designs, pharmaceutical firms are still experiencing a number of logistical and operational issues if they are to be adopted effectively with successful results. Trial design, trial monitoring, trial supply, data capture, randomization and other processes can contribute to major concerns to investigators. Most of these problems are there within traditional formats, and the issues become all the more pronounced when placed within an adaptive setting where changing parameters and restricted timeframes are more common. These issues reinforce the need to implement highly-efficient processes to manage demands.
Clinical trials packaging and drug supply is a major challenge for the pharmaceutical industry. Supply of materials in adaptive trials can be compromised by many different changes such as adding or dropping treatment arms, modifications in planned dose groups or sample size, modifications in primary endpoint, change in allocation to treatment arms, etc.
For efficient management, it is necessary to make sure that adequate supplies are available and packaged to meet the study’s requirements. In standard trial designs, the quantity of material needed is fixed and can be easily planned prior to the initiation of the trial. Also, proper planning and coordination of the activities of different players is required.
Drug Supply Services
Currently, adaptive designs take longer than necessary and hence cause preventable obstacles and time-burdens. To overcome the newly emerging challenges, companies that deal in storage, distribution and packaging outsourcing are providing a wide range of services to pharmaceutical companies to support adaptive clinical trials across the globe. This helps them to simplify processes when adapting to country specific protocols or reacting to changing needs mid-trial.
Also, innovative providers have introduced fast response services to provide compliant clinical trial supplies in a short period of time without affecting quality. This aspect gives greater flexibility to pharmaceutical companies to control the end to end process as well as the confidence of a provider who can quickly respond to ever changing needs. The operating processes include workflows that offer a streamlined approach, guarantee quality, and enable an instant turnaround of defined doses when sponsors need them.
A supplier that has facilities to store and deliver goods across the globe can allow companies to form a comprehensive global supply chain approach to keep sites supplied with materials.
Adaptive clinical trial designs lead to enhanced product development processes and enable improved patient safety. These designs also provide benefits in terms of reduced development costs and product time to market. However, in spite of their wide-ranging benefits there are potential pitfalls for every clinical trial. Therefore, potential risks should be taken into account when opting for a specific approach.
Produced from articles authored by Dr. Sue Miles, UK Site Director, PCI
About Packaging Coordinators, Inc.
Packaging Coordinators, Inc. (PCI) specializes in providing packaging solutions to the global healthcare industries that need to increase their products’ speed to market for commercial success. PCI brings the proven experience that comes with over 50 successful product launches a year and more than 40 years in the healthcare business. Continued investment and leading technology allows PCI to meet global packaging needs throughout the product life cycle - from Phase I clinical trials through commercialization and ongoing supply. PCI’s clients view the company as an extension of their business and a collaborative partner, with the common goal of improving patients’ lives.
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