How asking the right questions during clinical development planning can prevent costly mistakes down the line.

When a biopharma company, and its investors, get excited about a new molecule, it can be easy to dive straight into clinical development. The sooner you start the faster the results will come – at least that is the theory. In reality, when biopharma companies fail to do the necessary due diligence and craft a sound clinical strategy for drug development, they heighten their risk of making expensive mistakes.

The Tufts Center for Drug Development found sponsors implement at least one substantial protocol amendment for nearly 60 percent of all clinical trial protocols — and that roughly one in four of these amendments are “completely avoidable.” These amendments can cost more than half a million dollars in a phase 3 study and add an average of three months to the schedule, which can be devastating, especially for emerging biopharma companies with limited resources. Fortunately, when companies follow sound clinical strategies they can avoid these kinds of mistakes. It requires them to set aside more planning time up-front, but it will ultimately reduce time, costs, and risk down the line.

Who, what, where, when, why and how

Before opening trial sites and recruiting patients, biopharma companies need to define their big picture goals for a drug, including where and when they expect to launch, how much money they have to spend, and what the biggest obstacles will be to approval. Having this information in place from the outset will help them generate support from stakeholders, mitigate risks, and streamline partnerships with sites and vendors for a more efficient trial delivery experience.

This process begins by asking the right questions. The Five W and One H method is a useful format for clinical strategy development to ensure all regulatory, manufacturing/quality, preclinical/nonclinical development, clinical development, and other issues are covered. Working through these questions provides information to fortify and strengthen the clinical strategy, and uncover hidden risks or issues that the team can’t address on their own.

Below are key questions every biopharma team should ask themselves at the outset of a research program.

  1. Who is making decisions – and where are there gaps? An effective clinical strategy plan requires input from scientific, financial, and regulatory experts to achieve the necessary balance and avoid mistakes. If your team is missing one of these experts, find a partner who can help fill the gaps.
  2. What is your motivation? If you plan to sell the drug in Phase 2 or Phase 3, the development plan may have different deadlines and milestones than if you if you plan to take it to market.
  3. What regulatory feedback (if any) have you received? Every drug development process should include gathering feedback from regulators in target markets. That feedback will directly impact the development plan –and you haven’t yet received it, you need to factor that into your timeline.
  4. What prior successes or failures have you had? Whether you hit road bumps or saw early successes in preclinical research, that data should be considered when shaping the future direction of the research.
  5. Where is the compound manufactured and what is the labeling status? How and where a compound or device is manufactured will directly impact cost and regulatory approval. Understanding how these issues impact each other – and what changes can be made to lower costs and increase reliability – can improve the odds of success.
  6. Where do you plan to launch the drug? The answer to this question will determine where you need to host trial sites, and the types of data you need to collect to meet the needs of regulators.
  7. When do you need to hit key milestones? Understanding this driver will shape your development strategy — if you need to meet a critical data milestone to acquire funding, you may want to open more sites to expedite the timeline, whereas if your budget is tight, you may opt for fewer sites to manage costs.
  8. Why is this drug necessary? Defining the value proposition of the drug early in development will ensure you collect the right data to make your case to regulators, payers, providers and patients.
  9. How is compound testing going and when will it be finished? The duration of testing determines how realistic project objectives and deadlines are, and can help hone project timelines.
An effective clinical strategy plan requires input from scientific, financial, and regulatory experts … If your team is missing this expertise, find a partner who can help fill the gaps.

Crista Casey, Executive Director of Clinical Development


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