Clinical Trial Consulting

Strategic consulting services for clinical trial sponsors

Clinical research is complex by nature and strictly governed by various different standards and regulations. Moreover, the field has seen rapid technological advancements and shifts towards innovative new clinical trial models in the last few years, adding even more complexity to trial operations in relation to aspects such as regulatory submissions, marketing and outreach strategies, managing remote trials and data collection, managing data, and more.¹,²

In many cases, this quickly changing landscape and the numerous factors that need to be juggled simultaneously can make it difficult for sponsors to make strategic decisions and focus on their core activities. In such situations, sponsors might want to consider working with a clinical trial consultant who can assist in managing the diverse aspects of trial operations, driving down costs, and maximizing efficiency of resource use. In this article, we review the world of clinical trial consulting, covering the potential benefits of a strategic consulting service for trial sponsors as well as where sponsors and sites could look to find a consultant with skills matched to their needs.

What is a clinical trial consultant?

A clinical trial consultant, or clinical research consultant, is an individual or organization with in-depth knowledge and experience in various areas of clinical research, generally specializing in more than one aspect. Consulting services could be provided by a CRO with experience running a multitude of studies, or by an expert consultant who assists sites/sponsors/CROs in one or more aspects such as trial and protocol design, data management, or patient recruitment, to name but a few.

Depending on the specific challenges a sponsor is looking for help with, an expert in the matter can provide solid insights and bring a unique perspective and expertise to the table. Besides the broad benefit of the added expert perspective and the freeing up of resources and time to focus on core activities, particular potential benefits include things like accelerated trial design and start-up, more attractive patient-centric protocols that boost enrollment numbers, faster regulatory approvals, or the smooth setup of streamlined workflows with perfectly matched technological solutions.

How can a trial consultant help you design and execute better trials?

An expert or a clinical research organization (CRO) that provides strategic consulting services will be able to provide advice across the various stages of a clinical trial, from initiation to completion, in concepts such as those outlined below (and of course depending on the qualifications of the consultant or consulting firm):³,⁴,⁵

Formulating and refining actionable research questions and hypotheses

A clinical trial consultant can help drug developers and other sponsors refine broad ideas into formal research hypotheses that can be tested in accordance with regulatory guidelines. When the idea is not entirely clear, a good consultant should be able to help provide clarity in formulating a research question that addresses a need and sets the trial up for collecting the relevant data.

Trial and protocol design

Clinical trial consulting services can provide tailored insights into study design based on the research question, and help sponsors design streamlined, compliant trial protocols that can produce valid results with sufficient statistical power. In this regard, consulting could cover aspects such as:

• Identifying appropriate outcomes/metrics
• Defining eligibility criteria that encourage enrollment and retention and maximize accessibility
• Selecting a statistically powerful and relevant research method
• Data collection and analysis techniques
• Essentially any other aspect of trial design, such as those discussed here

Finances and budget planning

Creating a feasible and realistic clinical trial budget can be particularly challenging, as multiple variables must be considered and unrealistic forecasts can eventually result in a lack of resources.

Working with a clinical research organization that offers financial clinical trial consulting services might help you design a solid study budget. Financial consultants can draw upon their expertise and experience in this domain to help sponsors accurately predict costs, allocate resources, and proactively respond to potential setbacks and unexpected expenses.

Patient enrollment, engagement, and retention

The past of patient recruitment efforts focused on print media and local physician referrals has given way to diverse forms of clinical trial marketing. Social media platforms and search engines have become increasingly important for recruitment, as these spaces have massive user bases, which offers the potential to increase enrollment numbers and shorten recruitment timelines.

However, there is a learning curve involved in mastering the art of digital marketing, which is typically a separate skill set from that of the typical clinical research professional. With different ad formats, campaign types, and most importantly, distinct regulations and rules across platforms, it can be a daunting task to undertake digital outreach for trial recruitment. Add to that the fact that all study materials (all minor variations of ads, for all platforms) need to be approved by the IRB, and the situation becomes even more difficult to navigate. CRO services relating to patient recruitment will likely involve the use of digital marketing techniques, but even digital marketing professionals in a broader sense may be able to bring lots of useful knowledge to the table. A good consultant will help you target the right patient populations with engaging content, tailored to multiple high-traffic platforms and compliant with both internal and external regulations, and will also help you develop a monitoring plan to track and update ad campaigns to stay relevant and maintain high conversion rates until targets are reached.

Feasibility assessments

Strategic consulting in feasibility could apply to the various uses of feasibility assessments in clinical trials - in the feasibility of the study itself, site feasibility, budget feasibility, etc.

Skilled consultants might run simulations to determine if the research question, study methodology and design, and sample size are appropriately selected to provide accurate and statistically sound findings.

Regulatory consulting

Given the number of regulatory board submissions necessary to carry out clinical research, from NDAs and INDs with the FDA to IRB approval packets, trials risk serious delays due to rejection of any submissions.

Clinical trial consulting professionals who are well-versed in regulatory requirements will be able to assist in ensuring submissions are complete, avoiding common errors, selecting an IRB, and incorporating realistic timelines for approval stages. A regulatory consultant will review all submissions and identify possible problems that could result in rejection.

Statistics and data management

There are strategic consulting services dedicated to data management and statistics that can help you set the trial up for streamlined collection and organization of accurate and high-quality data. High-quality data translates into high-quality results and regulatory compliance, but it must be handled properly throughout its journey and also analyzed appropriately, usually by a trained statistician.

Specialized consulting services in this area could address topics such as:

• Running trial simulations and performing predictive modeling to assess trial protocols
• Designing protocols and identifying sample sizes to maximize statistical power
• Running comparative analyses to optimize trial operations
• Implementing suitable clinical data management systems for trial sites
• Assistance and training on clinical data management systems
• Education on data collection methods, including secure and responsible data processing/handling in order to demonstrate compliance

Medical and clinical consulting

Certain trials may require specialized medical knowledge or expertise. For example, if you are running a study for a rare disease, consider working with a rare disease CRO that has the appropriate medical knowledge and understands the unique requirements of such a trial. This aspect of consulting is related to patient safety as well as their ethical treatment, in that the study must demonstrate that it is not exposing participants to undue harm or denying treatment for individuals who need it urgently. Medical consultants can provide the necessary supplementary insight in this regard, and can help sponsors create effective study protocols, select appropriate (outcome-based) endpoints, and ensure regulatory compliance by ensuring that the study team has the required medical expertise for the trial.

Clinical operations and strategic consulting

Clinical trial consulting services are not only used during the design of a trial, but may be useful mid-trial as well. Consultants could be called upon to assist with innumerable possible aspects of trial operations, such as validating data management workflows, implementing additional training, or to improve process efficiency and ensure sites are adhering to protocol and regulatory requirements. Furthermore, if you are faced with any unexpected issues during a study, a clinical trial consultant could be hired to help find solutions and get the trial back on track as soon as possible.

For global and multinational studies - Localization consulting

When it comes to multinational studies, sponsors must comply with the standards of several different regulatory frameworks, both at the national and regional level. This requirement exponentially increases the regulatory complexities of a trial, and can become especially challenging for sponsors to overcome if they don’t have local knowledge in a given country. Beyond regulatory complexity, there are also cultural differences that can have a major influence on the acceptability and perceptions of a trial (i.e., culturally sensitive language in promotional materials), and demographic factors that can affect the feasibility of certain eligibility criteria or the study treatment itself (i.e., different disease incidence rates, genetic differences, etc.).

In such cases, working with a global CRO with strategic consulting expertise in managing multinational clinical trials can provide invaluable support and assistance in getting approvals, demonstrating compliance, and generally in making the trial culturally appropriate for each region in which it is operating. Alternatively, sponsors could work with foreign clinical trial consulting companies who can provide insight into the unique research environment and regulatory landscape of a given region.

Reputable clinical trial consulting firms and companies

Below, we have listed a few firms offering reputable clinical trial consulting services to act as a starting point for your search to find the right consultant for your trial:

• CTI Clinical Trial & Consulting
• Veristat
• Parexel

For trial sponsors looking specifically for clinical trial consulting services for patient outreach, recruitment, and enrollment, our intuitive and user-friendly online platform offers a great solution for matching with high-intent patients, including a useful pre-screening feature; have a look at Power.

Patients as clinical research consultants for patient-centric trials

Besides established consulting firms and CROs, there is another resource that can provide invaluable insights and useful information that sponsors can use to make smarter decisions throughout the clinical research process by designing patient-centric trials: Patients! Patients can be included as consultants throughout the trial lifecycle, but especially in the design stage, as they are uniquely positioned to offer first-hand insights. Some of the benefits of including patients as stakeholders in clinical research design include the following:

• As spokespeople and advocates for their communities, engaged/active patients can provide unique points of view that can help sponsors get out of their researcher mentality and design more patient-centric trials by incorporating patients’ real experiences, desires, and concerns.6
• Engaging patients early in trial design and development can heighten their interest in research studies in general, which can improve enrollment and retention numbers down the line by improving rapport in communities.
• Understanding patients' concerns and needs can help sponsors develop more appropriate research questions, study protocols, and mechanisms for incorporating feedback.
• Receiving regular feedback from trial participants can help sponsors highlight possible concerns and address them before they lead to more severe issues such as high attrition rates or negative perceptions that can end up dominating community narratives about clinical research.
• Working closely with patients can improve the capacity of the research team to engage patients with empathy, compassion, and to help patients feel seen and valued, which translates into improved adherence and patient satisfaction.

Conclusion

Clinical trial consulting services, whether from a dedicated trial consultant, a clinical research organization (CRO), or a patient group or individual patients, can be an invaluable resource for trial sponsors at any stage of the trial. Whatever the issue may be, there is likely someone out there with unique experience that can bring a fresh perspective and tools to come up with a practical solution. Clinical trial consultants draw upon their expertise from a multitude of past trials to help sponsors and sites navigate the complexities of clinical research and make sound decisions, with advantages ranging from reduced delays to better budget management, improved compliance, streamlined regulatory approvals, enhanced patient safety and engagement, and faster time to market.