Ringing in the new year with headlines about cancer deaths declining was a great way to start 2020 and celebrate the many innovative advancements pushing the industry forward. Technology continues to be added to the equation allowing data to be collected and analyzed in more effective ways than ever, therefore helping industry partner with physicians to more accurately determine which patients will benefit from these new advancements is critical. Increased visibility into the drug development process has boosted confidence and opened doors – which will hopefully make it easier to find patients willing to enroll in trials and companies eager to invest in the most promising treatments and therapies.
But for those on the research side, it’s widely known that many drugs continue to fail and there are numerous cancer patients still without viable treatment options that could survive, manage their disease or be completely cured had those drugs made it to approval. In fact, cancer remains one of the deadliest diseases in the world and the rarest forms have very few and sometimes no treatment options at all. In response, the number of drug trials underway continue to surge to new heights and the competition to get on the right track and succeed is fierce. As companies look at new ways to move their drugs forward and have their own role in lowering cancer death rates, where are the opportunities to save lives?
Find the Right CRO
Working with a dedicated Contract Research Organization (CRO) to oversee trial design start to finish can be a significant advantage. Even more so, a CRO that has preclinical, regulatory and clinical services and a strong track record and reputation for developing a well-defined clinical and regulatory strategy is especially helpful. A group like this can bring great insight into where drugs are failing along the development continuum and where the opportunities for faster approval exist.
Start with the End in Mind
Starting at the very beginning, a strong clinical strategy is a key strategic differentiator that could result in success as long as it is formulated with the end in mind. Also, from the get-go, it should be designed in an adaptive and dynamic way so if there are early indications that a drug is working, that path will continue. If not, necessary changes will be made to get things moving on the most direct path forward without starting from scratch. Achieving these goals with a trial necessitates a solid CRO that is smart and flexible. Furthermore, one that is specialized in oncology is a great asset to a drug company attempting to combat a disease that defies the odds and to this day, still lacks cures for so many cases.
Identify the Right Site
With a proper clinical strategy in hand, another strategic consideration that must not be overlooked and could propel more drugs to approval is researching and identifying an ideal clinical trial site. In addition to this, it’s crucial to understand that a strong relationship between the CRO and a site is advantageous for many reasons. The site should be able to support a CRO’s change-as-you-go strategy that evolves as new data emerges and features an adaptive design that could save time, money and resources. Multi-arm trials that leverage both expert knowledge in oncology drug development as well as data from preclinical models are common and if a unique regulatory development opportunity needs to be explored to validate patient response, the site must support the CRO as it shifts gears, adds arms and works to take the guesswork out of the trial as it morphs. While it may seem like just another check on an already complicated and lengthy list, finding the right site for a trial can give CROs and their clients an edge in overcoming the challenges of getting a drug to patients and testing that clinical strategy as quickly as possible. Therefore, site selection and a strong training program are key components of a successful trial that can’t be obtained without a solid study design.
Determine the Site’s Bandwidth
When choosing the right site, CROs should take the lead in carrying out the proper research and due diligence. Understand that many sites and their personnel have numerous studies going on simultaneously and adding to the workload could lead to costly mistakes. Before making a final selection, the CRO should ensure that the site isn’t overwhelmed and has the expertise needed to understand the study in great detail, a strong principal investigator (PI) to champion the trial, the right patients, and give it the dedication it requires – start to finish. Without proper attention and investment from the site, trials can suffer from slow enrollment, inappropriate patient selection, and errors in data collection and patient care. Problems of this nature not only sabotage short and long-term success, but they can deter sponsors and even worse – put patients at risk.
Get Complete Buy-In
The earlier an organization starts the selection process, the better. Engage the PI as early as protocol development and study design to ensure that they fully understand the trial and how the particular drug can potentially help patients. To maximize the partnership, the CRO should share all of the data and science available to make sure the site is fully invested in the trial and understands which patients have the best chance to benefit. Having the site 100 percent bought in to the trial is great for the relationship and for the trial moving forward.
Provide Ample Training and Communication
Once a site is selected and the team is not only committed, but knowledgeable about the study and its goals, the foundation is set for a proper trial. However, the real work is just beginning.
The best partnerships are characterized by open communication and as mentioned, good training. Each clinical trial is different and up-front training on the particulars of the trial is key to maintaining a strong trial throughout. Setting expectations with the site and having consistent and regular follow up also helps the trial to be conducted as smoothly as possible.
Measuring Success
In the end, the hope is that any drug in trial that shows the potential to benefit patients will have a clear regulatory path to approval. That’s the ultimate win. But given how long these trials can take, there should also be a plan in place to define a successful trial along the way and ensure that the goals and objectives are being met throughout. Indicators of success should be measured as early as the first-inhuman trial to identify any response the patient may be experiencing. This can range from stabilizing the disease, extension of time on treatment, changes in markers or tumor features, and understanding how the patient is feeling. Focusing on classical measurements of response by RECIST (Response Evaluation Criteria in Solid Tumours) will almost certainly lead to a missed signal early in development that could be key to defining a sensitive patient population and regulatory opportunity.
There is no greater news than seeing cancer deaths on the decline. But with more and more competition and money being put into drug development trials, companies must be smart about the approach and the partnerships they pursue in order to get their drugs to market faster or at all. In all aspects, the early planning stages of a trial are critical and set the stage for success.
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. For more information, visit www.TD2inc.com.