Correct study planning: Avoiding delays and achieving success in your clinical trials  

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 adds pressure on researchers to address the growing complexity of clinical study protocols. Failure to manage this complexity could slow down the momentum of drug development, delay approvals, and even compromise the integrity of your clinical studies. 

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 plan for the duration of your study. It helps you gauge whether your clinical trial is achievable and is critical to reducing any risks associated with undertaking complex R&D activities.1 There are three questions that can facilitate feasibility analysis: 

Do you have a sufficient recruitment process? 

Correct study planning also involves establishing how many participants a study requires to offer statistically powerful results, and using 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. 

Our experience tells us that the best study plans incorporate a creative patient recruitment formula.3 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 both phases 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 protocols.  

Furthermore, social media “listening” tools can be used to hear personal accounts of patients regarding their clinical trial experiences and expectations, which can help improve study design. With the number of active monthly social media users expected to reach 3.02 billion by 2021, companies are ill advised to ignore this platform of opportunity.4 Digital platforms can play an important part in growing patient interest in a clinical study and finding potential recruits, and as such, should be carefully integrated into study plans.  

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, with the average cost to develop and gain approval for a new drug being approximately $2.7 billion, rigor in your study planning is arguably the most important stage of the clinical trial process.5 


  1. Johnson, O. (December 2017). ‘Sponsors Ask: Is Our Trial Plan Realistic? Toward a Data-Driven Feasibility Assessment’. Applied Clinical Trials Online. Retrieved from: [Accessed 14/10/2018]
  2. Bose, S., Sandhu, A. and Strommenger, S. (February 2017). ‘Clinical Trials: A Data Driven Feasibility Approach’. Pharmaceutical Outsourcing. Retrieved from: [Accessed 14/10/2018]
  3. Clariness (2018). ‘Patient recruitment’. Clariness. Retrieved from: [Accessed 14/10/2018]
  4. 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.

Do you have a study that you would like to discuss with us? 

To learn how we can support your patient insights and recruitment, speak with an expert today.