Staying Relevant With Smart Indication And Incisive Trial Planning

It may seem obvious that #clinicaltrial planning needs to be well informed. However, in our experience at Phesi, many trial sponsors don’t do complete due diligence to optimize success. Even when they have successful outcomes, many trials take too long and cost too much.

That is never an ideal scenario, but sometimes is less risky, such as when a company is introducing a first- or best-in-class compound. However, when developing therapies in a fast-moving category – #oncology being a prime example – one missed variable in clinical development planning is guaranteed to cause catastrophe.

Scientific innovation is progressing at a rapid pace in oncology, especially in certain tumor types where targeted and immunotherapy agents have replaced standards of care practically overnight. Drugs like Gleevec (in CML), Herceptin (HER2+ breast cancer), Zytiga (mCRPC) and Keytruda (in advanced lung cancer) have left companies scrambling to salvage therapies that couldn’t compete in the first-line setting, or figuring out if/how to amend trial protocols to maintain relevancy in later lines of therapy.

In the high-stakes world of #clinicaldevelopment – one fraught with intense pressure from anxious investors and patient communities – ensuring success requires careful, incisive planning.

What do you do to protect your asset(s), and your trial?

  • Comprehensive, updated competitive intelligence is a critical factor in predicting and planning for likely scenarios. If other trials already in progress have the potential to change the landscape in the near future, a company may have to consider different indications, combinations, or lines of therapy.
  • One-time competitive research isn’t enough. In today’s environment of accelerated R&D and regulatory pathways, companies must closely monitor competitors’ progress and assess their potential advantages, including how quickly competitors are activating trial sites and enrolling specific types of patients.
  • Incorporating elements of another company’s approach may also be a successful pathway. For example, if you are studying a drug in patients with an advanced cancer, and if a competitive agent appears to be an appropriate comparator, opening up a new arm of your trial with that comparator may yield data you need for success.
  • Include as many patients as possible but not more than necessary, and remove unnecessary exclusion criteria to enable easier enrollment. The protocol must remain relevant to the “real-world” needs of your patient population.
  • Therapeutic niches such as immunotherapy may be “where the action is,” but unless you can leverage true breakthrough biotechnology, you may have better luck in disease areas with less competition and innovation playing out in the trial-sphere.

Clinical development is an intensely dynamic field, one in which unforeseen events – both external and internal – can alter the clinical trial environment. While it is often tempting to change course in the middle of a trial, it’s never ideal to amend a protocol once the trial is up and running.

We often get called in by clients to “rescue” trials with lagging enrollment, or those that aren’t otherwise proceeding as planned. Making minor adjustments is complicated enough, but when a whole trial is at risk of becoming redundant or irrelevant, it can be disastrous. However, with the right insights, solutions are always possible.

Above all else, amid all the factors you must consider in devising and adjusting your clinical trial plan, keep reminding yourself of the most important question: how can this trial best serve your patients? Are you truly filling an unmet medical need, or trying to get a slice of a growing lucrative market? Does it make more sense to scale back and focus on a smaller niche better suited to your limited resources?

Whatever your situation, we at Phesi can leverage our proprietary technology, experience and expertise to help you deliver therapeutic solutions to #patients in the most efficient way.

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