Clinical trials continue to make stunning breakthroughs in treating diseases, especially those that remained uncurable for generations.
One recent example making the rounds on the internet is Leqembi, which received FDA approval to treat early-stage Alzheimer’s disease.
The drug’s clinical trials recorded a 27% decrease in the rate of cognitive decline throughout 18 months.
These trials worked to check the spread of the coronavirus, and there’s no reason for them not to work now.
That said, setting up a clinical trial is neither easy nor quick. Clinical development services can mitigate some of these challenges and support successful trial completion.
If these FDA guidelines for conducting one are any indication, they require a boatload of volunteers and several years of close monitoring. That’s not including dedication and funding, among other things.
Modern medicine post-corona has to deal with uncertainties moving forward. However, clinical trials can turn them into opportunities if they possess the following essential qualities:
1. Technology
Time has been a significant hurdle in rolling out novel treatments since the advent of medical research, not only because the treatments can’t come fast enough.
According to a 2018 study by Johns Hopkins Bloomberg School of Public Health researchers, the median cost of clinical trials seeking to obtain FDA approval is estimated at USD$19 million.
It also stresses that the cost only accounts for less than 1% of the cost of developing new drugs, which currently plays between USD$2 billion and USD$3 billion.
Regardless, a failed trial can affect a pharmaceutical company’s bottom line. One such company reported a 15% decrease in its net income for Q1 2017 because of a failed Phase III trial for a heart failure medication.
Given the situation, there exists a need to hasten clinical trials without compromising research quality.
Automating outmoded tasks like data collection and management is a step in the right direction, given that the current process relies on human memory, which is highly prone to error.
The case report form (CRF) is one data resource that has benefitted from technological advances. Annotations allow reviewers to detect individual datasets throughout the CRF.
Because of this, using annotated CRFs promotes data consistency and collaboration with other research groups, if not authorities like the FDA.
Another example is the decentralized clinical trial. Moving research sites to a more convenient location (e.g., the subject’s home) reduces the subject’s need to travel to and from a hospital or clinic.
Data collection is done through videoconferencing, and medications are delivered to the subject’s doorstep, though this setup isn’t ideal for more complex procedures like surgeries.
2. Budgeting
A study presented during the American Society of Clinical Oncology’s annual meeting in 2021 revealed major disparities in research funding for various cancers.
For example, breast cancer research receives the most funding at USD$3.7 billion, yet cervical cancer research spends more per incident but receives less than a tenth of what breast cancer research gets.
Most medical researchers can agree that they often don’t look forward to setting a clinical trial’s budget.
But, like most things in life, clinical trials run on money, whether from federal programs or private consortiums. Without a steady stream of funds, even the most well-planned clinical trials can grind to a halt.
Arguably the most crucial caveat of budgeting is that it doesn’t only happen before the clinical trial. It occurs throughout the process, from negotiating cost sharing with all involved parties to assessing the trial’s results relative to the expenses.
That said, industry experts cite the negotiation process as a major hurdle in effective budgeting.
Trial sites know firsthand what they need based on the environment but struggle to communicate the information to sponsors.
Experts add that a lack of clarity between parties can cause clinical trial opportunities to shrink in number because of doubt, if not animosity.
Another crucial tip is to factor in hidden costs, especially for unexpected delays, which are all but inevitable in conducting clinical trials.
A study of over 300 trials during three pre-corona outbreaks—H1N1 influenza, Ebola, and Zika virus—found that too few trials accomplish their research objectives in time.
3. Recruitment
Researchers employ various recruitment techniques to reach the sample size necessary for their trials, ranging from word-of-mouth promotions to electronic health records.
There’s no one-size-fits-all method, as people’s behavior varies wildly. You can’t expect technologically challenged subjects to sign up for the trial online.
One of the characteristics of a good trial is that it doesn’t unnecessarily burden participants. It must have a clear picture of the kind of participants who can generate the most relevant results.
One survey discovered that people with chronic illnesses are more likely to participate in trials that test a potential cure for their conditions.
As for the ideal source of participants, healthcare providers are your best bet. According to the Center for Information & Study on Clinical Research Participation (CISCRP), a Boston-based nonprofit, three out of five patients prefer to hear about a clinical trial through their doctors.
However, the CISCRP also explains that only a tiny fraction of trial participants are referrals from healthcare providers.
It’s a missed opportunity, even as most healthcare providers agree that clinical trials can be viable options for their patients.
The nonprofit suggests establishing working relationships between doctors and researchers to support clinical trials in this manner.
Compassion
This last aspect may not seem scientific, but many professionals swear by its importance. It’s a must-have quality for nurses, so it stands to reason that other medical professionals should also possess it.
One such professional, former Duke Raleigh Hospital president, Dr. David Zaas, spoke from experience during a medical conference in Durham, N.C. in 2019.
He participated in a Phase I clinical trial for his leukemia in 2017 (with his then-13-year-old son as the bone marrow donor). Since then, he’s urged trial researchers to practice ‘soft skills’ like compassion and respect.
Such a case is an example of what the FDA refers to as ‘expanded access,’ though many call it ‘compassionate drug use.’
A medication or procedure still under trial can be administered to a participant with a life-threatening condition, and no viable alternatives are available.
There are risks involved, given that the medication or procedure’s safety and efficacy have yet to be proven.
Conclusion
As modern medicine will likely face uncertainties, clinical trials will be at the forefront.
Even in this post-corona future, they’ll perform the same tasks they’ve done in the past: discovering new ways to treat health conditions.
Only this time, trials can be conducted more quickly and effectively through technology, budgeting, recruitment, and compassion.
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