With the emergence of basket trials in the early-phase oncology setting, clinical research teams are…
In my last post we looked at the first of three essential assets that your team should look to acquire before you launch an oncology clinical trial. Today’s post will outline the second: A Visionary Drug Development Plan.
Prerequisite #2: Visionary Drug Development Plan (Tweet this!)
A robust scientific model is a crucial first step in the successful development of a product and yet this step alone will not guarantee success. The science behind the product must show more than a strong hypothesis in addition to reliable results. It also needs to be innovative and more importantly, resistant over time.
Developers will see a much greater return if they invest time and money in adapting their technology to fit a long-term development plan. Scientists must see beyond the limits of good fundamental science and open themselves up to the clinical necessities and daily realities of both medical oncologists and their patients if they hope to create a truly visionary drug development plan.
In the short run, a development plan should include the feasibility throughout all phases of clinical trials (from phase 1 through 3). Long-term development plans present the biggest challenge for developers because they not only need to define the product placement in today’s market but for as long as 10 years down the road.
This involves not just the product, but also the standard of care and comparator compounds to be used throughout the clinical development process to accurately assess the drug’s efficacy. Developers are increasingly likely to invest in comparative studies to ensure they are launching accurate, state-of-the-art products. This will require help from marketing to foresee what the comparator drugs are likely to be over the next 5 to 10 years. Your ability to make accurate long-term projections about the life expectancy of the drug will give you an edge over more recent discoveries from competitors. This long-term projection is also applicable to patent life, which also presents competition from generic equivalents that are impossible to avoid.
Should a drug pass all the steps leading to its approval, it still does not guarantee success in the market. At that point, developers will face a different category of stakeholders such as third party payers like insurance companies and government regulatory agencies who will determine whether the drug will be added to their formularies. Clinicians, the patients and their families, also have considerable influence on the survival of the product. At this level, treatment decisions are based on a myriad of criteria from personal preferences, efficacy and safety issues, communication or information about the product, to clarity of drug labeling and comprehension of the target patient population.
Any one of these issues can significantly improve or harm sales, future investments for the company and the public’s opinion of the product and/or the company. Unless the developer holds a miracle drug, a product that requires a long IV administration every two days is just not going to succeed. Therefore, accurate market insights and clinical research that includes the patient perspective are extremely important even if the drug has proven its efficacy. Even to this day, this aspect of research is seriously lacking in the longitudinal development plans of most drugs.
The National Cancer Institute (NCI) is currently conducting multicenter trials to test a new method of monitoring patient adverse events through the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Event (PRO-CTCAE). The PRO-CTCAE provides a web-based platform to collect patient reports of symptoms they are experiencing while undergoing treatment, for the purpose of enhancing adverse event reporting 1.
PRO-CTCAE is based on findings that suggest the reporting of adverse events directly from the patients is significantly correlated with measures of functional performance and health status, as opposed to adverse events reported by clinical staff2. This secured web-based platform for patients, investigators and clinicians is also thought to be more accurate and reliable than patient self-report questionnaires and allows adverse events to be directly reported by cancer patients taking part in clinical trials, instead of having them interpreted and modified by clinical staff to fit the CTCAE.
This means that a visionary development plan, that is open to more sophisticated patient-tailored tools and that shares long-term clinical goals with every stakeholder touched by the disease, i.e. developers, investors, medical and para medical teams, patients and their relatives, will contribute greatly to the optimization of treatments against cancer.
Stay tuned for Essential Asset #3: Strategic Advisors & Strong Leadership