At OCT Clinical, we believe proper clinical study design preparation is an essential step in the clinical development process. Contract Research Organizations can bring great value through the trial lifecycle by ensuring proper study design and planning. On the other hand, poor clinical study management inevitably results in tremendous losses for Sponsor, CRO, and patient alike.
But efficiency aside, what are some of the specific areas improved through clinical study planning? Ultimately, this depends on the organization and the expertise they bring. Here, we list a few of our own aims and outcomes when managing clinical trials.
Biostatistics Services in Clinical Study Design
No clinical trial can be successful without proper implementation of biostatistics. The role of the biostatistician or biostatistics team begins during the clinical study design phase and carries through to the end of the project. Biostatistics experts should be consulted on a variety of critical matters, including study type and ethics, data management, randomization, sample size, and data analysis. An integrated approach that prioritizes expert biostatistics services allows for more robust data collection and integrity.
Improving Data Management
Clinical Data Management (CDM) has always been a key component of clinical development, but it grows in importance as the clinical trial landscape becomes more complex. Furthermore, CDM methods must be determined as soon as a study is initiated, making them inextricable from the design phase of managing clinical trials. CDM processes have become more widely discussed in research communities since the start of the COVID-19 pandemic, which accelerated the rise of the “digital clinical trial”.[1] Technology enables a host of new research methods, all requiring extensive planning. One such example is micro-randomized trials (MRTs). MRTs are currently being used to develop patient engagement solutions in mobile health technology, and can involve thousands of randomizations.[2]
Innovative data management methodologies — in tandem with strong biostatistics services — create stronger clinical trials. But in order to implement them successfully, they must be part of the clinical study design phase.
Managing Clinical Trials by Therapeutic Area
The components of clinical study design vary based on a large pool of factors. Certain therapeutic areas bring in an entire set of considerations that can determine the course of the study. This is especially true of oncology studies, which can require a unique set of CRO services.
Choosing the right oncology CRO is the first step in robust clinical study design. For instance, experienced oncology CROs can consult on adaptive trial design. An article from the American Cancer Society notes that adaptive design “allows prespecified modification to different aspects of the trial,” which can aid in clinical development for oncologic indications.[3] This has ramifications for the planning stage of the study, and calls for an expert eye. A global CRO for oncology research is best equipped to handle these specialized study designs.
Prioritizing Patient Centricity
Patient-centric study design is more than just a passing trend in the clinical development arena. It is no longer enough to simply consider the patient perspective when planning clinical trials; now, the standard is shifting towards actively involving patients in the clinical study design and protocol phase.[4] This requires applying the best CRO services for patient engagement, which help gather information about patients’ motivations, needs, and lifestyles.[5] These factors are critical to the initial stages of clinical study management. Taking these steps early on is the only way to foster engagement, trust, and communication through the rest of the trial lifecycle.
As a CRO managing clinical trials in Eastern Europe for 15 years, the team at OCT Clinical is well-versed in clinical study design. We help Sponsors successfully navigate the factors that are unique to their clinical development project, and adapt our CRO services accordingly. Learn more about our clinical study design services, or contact us to find out how we can help with your current clinical trial needs.
[1] Npj Digital Medicine - Digitizing clinical trials: https://www.nature.com/articles/s41746-020-0302-y
[2] Springer Link - Practical Considerations for Data Collection and Management in Mobile Health Micro-randomized Trials: https://link.springer.com/article/10.1007/s12561-018-09228-w
[3] ACS Journals – Cancer. Clinical trial design: Past, present, and future in the context of big data and precision medicine: https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33205
[4] Springer Link - Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies: https://link.springer.com/article/10.1007/s43441-020-00176-6
[5] National Library of Medicine - Patient centric approach for clinical trials: Current trend and new opportunities: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4504054/
