8 Obstacles to Success in Human Trials

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Human trials play an integral part in developing, supporting and providing peer-reviewed evidence of current and emerging therapeutics - whether they are pharmaceutical, dietary or lifestyle-focused. It’s true that, while with the best intentions, a good hypothesis can go a long way in predicting a good outcome at trial, nothing is ever assured.

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TL;DR:

• Remember and discuss these points at length to avoid failure
• Consider them all - assume your trial will fail
• Don't leave yourself second guessing
• Planning is arguably the most important part of a trial

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So, what went wrong? Years of planning, project managing, recruiting and enrolling participants, rigorous and high-quality data capture at all stages... yet things haven’t worked as well as you and your team had planned. Let’s get into the 8 main obstacles to success in human trials:

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1. Participant Recruitment

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Participant recruitment is one of the most crucial aspects of a trial, and it can significantly impact the trial's success. Recruiting the required number of participants within the specified time frame can be challenging (potentially) due to strict inclusion and exclusion criteria, lack of awareness among potential participants, and geographical barriers.

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Several factors can impact participant recruitment, including the complexity of the trial, participant eligibility criteria, and the availability of appropriate participants. It is essential to develop a comprehensive recruitment plan to ensure that the trial can recruit enough participants to meet its objectives. Be realistic - is the effect you're measuring likely to be present in your estimated groups?

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2. Funding

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Trials can be expensive, and securing funding - whether it's a prestigious grant or your own funds - can be a major obstacle. Lack of funding can lead to delays or even termination of the trial before it's even begun. The cost of running a trial includes a variety of expenses such as research staff, equipment, outsourced expertise, study drugs or devices and software.

Without adequate funding and appropriate budget planning, the team may not have the necessary resources to conduct the trial properly, leading to poor-quality data and results. It's good practice to repeat trials. Can you prove that your tested hypothesis is valid time and time again? If you want to repeat it, you'll want it to be for the right reasons.

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3. Regulatory Approval

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Trials (especially clinical trials using high-risk interventions) require approval from regulatory authorities, and obtaining this approval can be a lengthy and complex process. Regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have strict guidelines that must be followed to ensure the safety and efficacy of the study.

Obtaining regulatory approval is a major first hurdle to overcome since the study cannot proceed without it. A delay in obtaining regulatory approval can lead to a delay in the start of the trial, which can affect the feasibility of the study. However, in the case of much lower-risk trials, regulatory approval is sometimes not necessary. Be sure that you are aware of what it is you're investigating and what impact it has from a regulatory perspective.

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4. Participant Retention

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Retaining participants throughout a trial and ensuring their compliance can be a challenge. Participants may drop out due to adverse events, lack of interest, or other personal reasons. Participant retention is a major concern for any trial since it affects the claimable and perceived outcomes of the trial- at least from a statistical perspective. A high dropout rate can lead to incomplete data, reducing the statistical power of the study. Outcomes can then be misleading if the trial was not successful. Was it destined to fail with such few participants? Or was it going to fail anyway due to other reasons? The hypothesis, the intervention, the dose, or the population used? Minimise second guessing at all costs.

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5. Data Management

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Collecting, managing, and analysing data is a critical aspect of trials. However, managing data from multiple sources can be challenging, and errors can occur - especially when disparate data capture methods are used. Data management is essential for the success of a trial since it directly affects the quality of the data collected. Poor data management can lead to inaccurate results, which can affect the validity of the study. However, using a secure and validated data capture and data storage solution can prove incredibly beneficial.

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6. Site Management

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Managing multiple trial sites can be challenging, especially when they are located in different countries. Ensuring consistency in procedures and data collection across all sites is critical for the success of the trial. Secondary difficulties one might experience in this context, too, can be language barriers or language breakdown when many trial staff members and participants might be geographically disparate.

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7. Lack of Participant Interest

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Recruiting enough participants to participate can be difficult, to begin with. Lack of interest in the study or a lack of awareness about it, the purpose and the wider implications of the work on the whole population is certainly another important consideration here. Participants may not be willing to participate in a study due to concerns about the study's safety or effectiveness. The trial design might also be far too burdensome and might then put off participants. Lack of participant interest is critical for the success of a trial since it affects the feasibility of the study.

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8. Ethical Concerns

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Trials must adhere to strict ethical guidelines, and any violation can lead to serious consequences. Ensuring that the trial is conducted ethically can be challenging. Ethical concerns are major considerations for the success of a trial since they affect the validity of the study. Any violation of ethical guidelines can lead to the rejection of the study, affect the reputation of the trials team, and even lead to legal consequences.

We all know trials to be expensive, complex and multi-faceted, and there are several obstacles that can hinder their success. Addressing these eight obstacles can help ensure that trials are conducted efficiently, ethically, and effectively, leading to more successful outcomes for participants and researchers alike.