Early clinical development typically involves Phase I and Phase II trials. Because they generally involve the first tests of a drug in humans, trials in these phases are at a high risk of failure following a simple planning mistake. Drug developers should consider clinical development consulting to increase their chances of success in the early stages. Other specific things they should prioritize to optimize the clinical development process include remote clinical trials, a tailored clinical trial design, and careful decision-making to ensure compliance with regulations. Here are four actionable strategies that can help minimize drug development time, manage costs, and increase the chances of commercial success.

Consider modeling and simulation

Typically, early clinical development trials want to establish a drug’s safety and tolerability. They also attempt to demonstrate that the drug can have the intended effect (a.k.a., Proof of Concept). Wouldn’t it be wise to test all these in a virtual world and identify the drug’s potential weaknesses before throwing millions into a real clinical study? Modeling and simulation can help you explore and quantify a medicine’s risks before launching the study. Using complex mathematical models, you can examine the drug’s effect in a “virtual patient population” to help you better plan and tailor the study to at home clinical trials specific requirements. Because you get the chance to observe the medicine’s effect with different model inputs, simulation makes it easy to test assumptions, understand and characterize risks and identify opportunities to optimize outcomes. Generally, this strategy helps drug developers improve their clinical trial planning and design. Regulatory bodies like the US Food and Drug Administration (FDA) encourage simulation and modeling.

Work closely with regulators.

Working closely with regulators in every stage of drug development is a critical success factor in clinical trials. It’s an effective strategy to mitigate compliance risks inherent in drug development and increase the chances of early drug approval. Regulators in the US and Europe, in general, have tools to help you ensure your early clinical development trial meets regulatory requirements. Seeking advice from the correct regulatory body provides the required standard of quality, acceptable study designs, and the correct pharmacokinetics and pharmacodynamics.

Use the right study design and protocol.

A clinical trial protocol outlines your trial’s design, objectives, statistical considerations, methodology, and organization. A flawed protocol can cause violations, deviations, and incorrect procedures. It can also result in missing, invalid, or uninterpretable data. While a perfect protocol is a theory, your trial design should prioritize patient safety and promote solid, interpretable findings. The design should encourage flexibility, so you won’t need protocol amendments after every decision. Consider a clinical development consultant for a compliant trial design. After finalizing the clinical trial protocol, your clinical trial team should follow it closely, not only for regulatory reasons but also to prioritize patient safety and prevent erroneous outcomes and conclusions.

Recruiting difficulties cause trial delays, as studies can only be concluded after meeting the required number of participants. As a result, it takes a lot of time to develop a product and bring it to market. Identify factors influencing recruitment, both positively and negatively, and use them to improve recruitment. Eliminating overly restrictive eligibility criteria can help improve recruitment and retention.