Strong Project Management Propels Clinical Development Success

The Cost and Challenges of Drug Development

The American Journal of Health Economics (AJHE) previously estimated the cost of bringing a new drug to market is US$ 802 million based on the research and development of 68 drugs launched by 11 pharmaceutical companies.¹ But new estimates suggest these costs have risen even more to a staggering US$ 2.3 billion, while at the same time, venture capital funding for pharmaceutical and medical device companies and return on investment is declining.²

According to the Journal of the American Medical Association (JAMA), only one in five trials is completed on time.³ Given rising costs and shrinking investments, it has become even more crucial for companies to spend strategically and resource appropriately beginning at the early stages to ensure program success.

Here we examine how strong project management throughout the entire drug development lifecycle saves time and money.

Project Management in Drug Development

Broadly, project management involves planning, coordinating, and overseeing tasks, resources, and timelines to achieve specific objectives within a set budget. The role encompasses initiating, executing, and closing projects while ensuring effective communication, risk mitigation, and adherence to goals. Project managers lead teams, manage constraints, and drive successful outcomes in diverse industries and contexts. The biotechnology industry is one of the most complex and heavily regulated spaces.  clinical project management is a specialized field applying project management principles to clinical trials and medical research; however, there are several key differences between standard project management and clinically focused project management that are important to recognize.

Firstly, clinical trials encompass many ethical and regulatory considerations compared to other industries. Clinical trials involve human participants, necessitating rigorous ethical standards, participant consent, and privacy protection. Subject to strict regulations from health authorities, clinical trial sponsors are required to adhere to specific guidelines and ethical considerations.

Secondly, most trials are approached from a ‘patient first’ perspective. Patient recruitment, safety, and engagement are central, as trials impact participant health and well-being. For this and other reasons, trials follow detailed protocols outlining study methods, eligibility criteria, and treatments, demanding strict adherence to meet the comfort of patients and assurance of valid results. Project managers play an important role in ensuring protocols are followed, directly benefiting both patients and sponsor companies.

Clinical trials also necessitate frequent complex and specialized collaboration across many groups of stakeholders. Clinical project management involves interdisciplinary collaboration with medical experts, regulators, data managers, and more to ensure the development and continued management of a successful program. In addition, trials often occur across numerous locations, demanding coordination among various sites and stakeholders.

Lastly, to maintain the trust of patients and ensure data integrity, data precision, and security are a must. Handling medical data requires accuracy, quality, and compliance with medical terminology and standards, while the sensitivity of medical data mandates strict data security and privacy measures.

How Effective Project Management Contributes to Cost Savings

Clinical project management’s unique challenges arise from regulatory complexities, ethical considerations, medical expertise, patient focus, and specialized protocols. Project management plays a crucial role in helping companies save money and time through various methods and strategies.

Here are some ways in which effective project management can contribute to cost savings:

• Scope Management: Clearly defining and managing the scope of a project helps prevent “scope creep,” where the project’s requirements keep expanding beyond the original plan. This avoids unnecessary work and associated costs.
• Timeline Development and Management: Efficient project scheduling ensures tasks are completed on time and in the appropriate sequence. Delays can lead to increased costs due to extended resource usage, missed opportunities, and other unforeseen expenses.
• Cost Tracking and Budget Control: Project managers monitor expenses against the allocated budget. Any deviations are identified early, allowing for corrective actions to be taken to avoid budget overruns.
• Stakeholder Communication: Clear communication with stakeholders includes consistent and tailored messaging to the various people involved and impacted by a project. Effective communication helps keep team members informed and on task, manage expectations, and avoid misunderstandings that could lead to costly changes or conflicts.
• Effective Collaboration: Proper use of project management tools and methodologies facilitate collaboration among team members, reducing duplication of efforts, misunderstandings, and wasted time. This enables project teams to make informed decisions, work toward key objectives, and pivot when barriers to objectives are encountered.
• Risk Management: Project managers identify potential risks to the project’s success early on and develop mitigation strategies. This upfront planning prevents costly surprises and helps the company allocate resources to manage these risks effectively.
• Resource Allocation: Project management involves the proper allocation of resources, including personnel, time, and budget. By efficiently distributing resources, projects are less likely to face over or under-allocation or unnecessary expenditures. Optimized distribution of personnel minimizes downtime and maximizes productivity.
• Quality Assurance: Effective project management maintains high-quality standards, reducing the likelihood of rework, defects, and consumer complaints, all of which can incur additional costs.
• Vendor and Supplier Management: Project managers ensure vendors deliver goods and services as agreed upon in terms of quality, quantity, and timeline. This prevents costly delays or disputes. An expert project manager will also bring the value of prior experience with vendors, which could save valuable negotiating time during contracting.
• ‘Lessons learned’ from Past Projects: Project managers often review past projects to identify what worked well and what didn’t. This knowledge is used to refine processes, reduce inefficiencies, and avoid repeating costly mistakes.
• Change Management: Effective project management helps teams adapt to changes in a thoughtful and constructive manner, avoiding disruptions and mitigating unnecessary costs associated with surprise changes.
• Thorough Documentation: Well-documented processes and project plans ensure that knowledge is preserved and can be easily transferred to new team members. This prevents knowledge gaps and reduces the time and costs associated with onboarding new resources or starting new but similar projects.

Project management provides a structured framework ensuring projects are executed efficiently, risks are managed, and resources are optimized. This leads to cost savings for companies by minimizing waste, enhancing productivity, and preventing costly setbacks.

Making Project Management Work for You

The value of strong project management to the drug development process is clear, but there are ways to maximize the benefit within your organization to ensure program success.

Invest in Project Management

Companies may not consider project management until well into the development and trial process. Some even wait until they are thinking about study start-up, missing an opportunity to capitalize on efficiencies, or wasting time and resources. Hiring or contracting with clinical project management experts even before the protocol is fully developed will provide structure to your early stages and help your team develop feasible timelines and identify potential risks to manage stakeholder expectations from the start. An experienced clinical project manager can help your team avoid the risks and pitfalls they’ve encountered previously and will save you more than their total compensation cost in spades!

Focus on Foundations

While it is too much to expect every person on your team to be an expert in project management, creating a project management-friendly culture in-house is a highly effective way to get your team ‘speaking the same language.’ Ensuring all staff has access to project management tools and templates and setting a companywide expectation that staff is trained in and regularly utilizing these tools is a step in the right direction, especially for newer companies that may not have standard operating procedures fully developed. Well-established tools such as Smartsheet or Microsoft Project do come with an associated licensing fee, however, due to the ubiquitous nature of project management, there are many other low or no-cost options to consider.

Don’t ‘Reinvent the Wheel’

The life sciences industry rewards innovation, creativity, and speed. Project management at its core is a set of basic principles and methodologies that have proven valuable across industries that pairs well with the pace and complexities of the industry. A well-versed clinical project manager will know how and when to apply ‘tried and true’ approaches and where in the process it may be worth the risk to try something new. To discuss how to maximize your clinical development programs and clinical operations efficiency, contact Halloran.

References

1. Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ. 2009 Feb 3;180(3):277-8. doi: 10.1503/cmaj.082041. PMID: 19188619; PMCID: PMC2630333.
2. Philippidis, A. (2023) ‘The Unbearable Cost of Drug Development: Deloitte Report Shows 15% Jump in R&D to $2.3 Billion’, Genetic engineering and biotechnology news, 28 February. Available at: https://www.genengnews.com/gen-edge/the-unbearable-cost-of-drug-development-deloitte-report-shows-15-jump-in-rd-to-2-3-billion/ (Accessed: 14 August 2023).
3. Shadbolt C, Naufal E, Bunzli S, et al. Analysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery. JAMA Netw Open. 2023;6(1):e2250996. doi:10.1001/jamanetworkopen.2022.50996