Pharmaceutical companies of today are under increasing pressure to fully demonstrate the safety, effectiveness, and economic value of new medicines. The industry shift towards precision medicine and outcomes-based assessments also puts pressure on researchers to address the growing complexity of clinical study protocols. Failure to manage this complexity could compromise the integrity of your clinical studies, slow down the momentum of drug development, all leading to delay in approvals.
A successful clinical trial requires a crucial first step: planning. Correct study planning is a rigorous process comprising consideration of study feasibility, recruitment processes, and the power of modern technology.
Is your study feasible?
Planning must begin with an assessment of study feasibility. Conducting a feasibility analysis is a data-driven approach that plays a huge part in ensuring you can appropriately plan the required resources and timeline for your study. It helps you gauge whether your clinical trial is enrollable in the selected countries and is critical to reducing wasted resources and budget.1 There are three questions that can facilitate feasibility analysis:
- Is the indication viable?2 A clinical study targets specific patient demographics to ensure the drug is safe and efficacious. Part of correct study planning is to understand the current disease in the general population by gathering relevant information about prevalence, standard of care, disease awareness, patients understanding of the disease, to name just a few topics. This detailed information can be obtained directly from patients, their caregivers, and the medical community through surveys and interviews. This is a time-consuming first stage to study planning, but one that can make or break a clinical trial.
- Is the protocol comprehensive? You need to ensure you can generate quality clinical results, but this can be compromised by lack of a comprehensive protocol. Developing the protocol can be complicated, involving the defining of study objectives, methodology, inclusion/exclusion criteria, efficacy and safety assessments, reporting, and adverse events monitoring, among other factors. A data-driven approach can reduce complexity and help refine the protocol while also ensuring it remains comprehensive. Such an approach also ensures an efficient timeline is set and that the role of researchers is made clear in respect of how to realistically collect data and analyze results.
- Is the investigation site suitable and able to cater to the protocol design? If we consider how complex some clinical trials can get, it’s easy to see the need to be selective with the partners you work with. An important aspect of study feasibility is making sure your study partners are available, accessible, and possess the site capabilities and tools that your study requires. Just as patients are screened before being accepted onto a trial, so should investigation sites.
Do you have a sufficient recruitment process?
A sufficient recruitment process starts with quantification; how many participants do you require to offer statistically significant results? Once you have these statistics, you can confidently build your trial plan around these specifications. This is also when you can use the personas you devised as part of study feasibility to devise a recruitment strategy. This will help you avoid the many barriers associated with patient recruitment and keep your trial on schedule. This stage of study planning needs to be thorough as the leading cause of missed clinical study deadlines is patient recruitment, which takes up to 30% of the clinical timeline and carries a hefty price. The main reason for these delays is poor planning, which can result in the need to change objectives and participant selection criteria.
Our experience tells us that the best study plans incorporate a creative patient recruitment formula that is guided by a better understanding of the patient.1 This formula is constituted by outreach and marketing strategies designed to increase patient awareness and interest, along with mechanisms to facilitate quality patient referrals.
A sufficient recruitment plan is also patient-centric, comprising measures that will make it easy for patients to take part in the trial. This can include simplifying the process of informed consent, reducing the burden of site visits, and providing patients with adequate information about the study and their significance to its success.
Are you harnessing the power of modern technology?
Utilizing technology is another key aspect of the planning process and will ensure your study isn’t outdated and has a strong infrastructure. The value of technology starts at the outset of study planning, when you are assessing feasibility and ensuring your protocol is comprehensive. During the initial stage of study planning, you will need to scour extensive data sources to collect information that will help you enhance feasibility and inform your protocol development. With the power of advanced technologies for data access and utilization, you can assess patient eligibility criteria, refine your target patient group, improve feasibility analyses, and validate protocol-assumptions.
Study planning – A vital investment
Correct study planning with a focus on feasibility, recruitment, and modern technology might feel like a tedious approach to pre-trial preparation. However, companies who want accuracy and efficiency in their clinical studies will see this as a vital investment. Indeed, rigor in your study planning is arguably the most important stage of the clinical trial process.2
To learn how Clariness can help you improve your study planning and help you achieve your clinical aims on time, download our Study Optimization Checklist here:
1. Johnson, O. (December 2017). ‘Sponsors Ask: Is Our Trial Plan Realistic? Toward a Data-Driven Feasibility Assessment’. Applied Clinical Trials Online. Retrieved from: http://www.appliedclinicaltrialsonline.com/sponsors-ask-our-trial-plan-realistic-toward-data-driven-feasibility-assessment [Accessed 14/10/2018]
- Bose, S., Sandhu, A. and Strommenger, S. (February 2017). ‘Clinical Trials: A Data Driven Feasibility Approach’. Pharmaceutical Outsourcing. Retrieved from: https://www.pharmoutsourcing.com/Featured-Articles/333830-Clinical-Trials-A-Data-Driven-Feasibility-Approach/ [Accessed 14/10/2018]
- Clariness (2018). ‘Patient recruitment’. Clariness. Retrieved from: https://www.clariness.com/patient-recruitment/ [Accessed 14/10/2018]
- DiMasi, J.A., Grabowski, H.G., Hansen, R.W. (2016) ‘Innovation in the pharmaceutical industry: New estimates of R&D costs.’ Journal of Health Economics, 47, pp. 20-33.