Precision medicine or personalized medicine has been emerging as the trendiest area of research in oncology thanks to recent advances in technology. There is good reason for that – often, patients with the same type of cancer can respond differently to the standard treatment. Personalized medicine gives them a fighting chance by tailoring the treatment to their specific tumor’s genetics.
Precision medicine holds the promise of finding a cancer treatment personalized to each patient, making treatment resistance a thing of the past. In this future, patients will be given a genetic test so they can be prescribed the treatment their cancer is most likely to respond to, and be spared all the rest.
Cancer research now is heavily focused on testing treatments targeting the cancer-causing genetic makeup of different tumors, no matter where the tumors develop in the patient’s body.
These treatments are known as targeted therapies and patients are already asking about them. Many treatment-resistant patients take it upon themselves to learn about alternatives and search for trials testing these therapies – this is what our experience on our patient-facing platform shows.
While targeted therapies are very promising and attractive to patients, for professionals involved in the planning of clinical studies the question remains:
Are targeted therapies complicating study protocols?
The short answer is yes.
Interventional studies done on cancer patients have very specific eligibility criteria – the patient needs to have a particular kind of tumor with a genetic change the therapy can target. This limits the potential pool of patients but it also limits the potential number of sites and investigators equipped for this kind of study.
Patient recruitment might be harder
Targeted therapies take a lot of time to be developed and the result is a pricey treatment not many patients are able to afford. That and the promise of finally finding a treatment the tumor will respond to, make clinical trials testing personalized treatments a very attractive option.
Even so, finding patients for a targeted therapy trial might be especially difficult because of the eligibility criteria. Not every cancer patient has the specific tumor genetic changes the study team will be looking for and testing for those changes is not straight-forward either.
Recruitment could be further complicated by geographic barriers. There simply won’t be a high concentration of patients with the same tumor genetic changes at the same place (same city or province). Because of the extensive testing and observation required by such a trial, however, virtual trial modalities might not be the answer.
Solving this issue, of course, is associated with higher costs for the Sponsor. An incentive for patients who live away from a trial site could be reimbursing travel and accommodation costs – yet, not every patient will have the means or the physical capacity to travel as frequently as the protocol requires even if reimbursement is on the table.
Another matter to consider could be patient referrals, which leads us to the next point.
Finding the right centers and doctors to partner with could be tricky
Identifying genetic changes in a tumor requires a biopsy. The sample of the tumor is then sent to a special lab for DNA sequencing. This complicates the process and makes finding and partnering with the right medical centers and doctors even more of a priority.
You need to identify sites with the right equipment as some resources cannot be provided by the Sponsor; then, you need to identify the right investigators – since the burden on them in this kind of trial is heavier, they need to be willing to dedicate the time and collaborate.
Maybe a bigger network of investigators in every country could be what helps patient recruitment – then you need to identify the doctors most likely to be involved in treatment-resistant cases for example and know the patient pathway in the given country well enough to involve the kind of professionals who can refer eligible participants at the right time.
This approach is a bit of a departure from the standard centralized trial as the protocol inevitably makes the patient pool smaller. TrialHub can help you not only identify the right sites but connect you to country advisors right away so you can know the local landscape and meet patients where they аre at.
Not only that but you can check how other similar trials performed with our Trials Performance Analysis – how much recruitment was delayed and how many rescue sites were open.
In conclusion, research in targeted therapies highlights the need to think out of the box and collaborate with the right partners at every level. Choosing investigators wisely and building an infrastructure that can support sites that may not be technologically prepared but are convenient for patients could be the key to planning a successful trial in the space.
If you want to know how Oncology is performing as a therapeutic area in Q1 of 2021 or how Covid-19 affected Oncology research, check our 2021 Market Overview. We update it as new data becomes available so stay tuned to see trends for the entire 2021.