Despite some good moments here and there, for most of us, the past few years have been tough, to put it mildly. The difficulties of the pandemic, supply chain shortages, and inflation have had long-reaching effects, including on clinical trials.
Clinical trials have long been costly and complicated to organize. But today, the challenges involved are greater than ever.
● Cost increases for any supplies, material, and compounds that are also being used to treat Covid-19 patients.
● A major price increase in organic chemicals necessary for the preparation of medications. Costs have gone up a staggering 54.8% in the past year alone!
● A notable decrease in available study participants. This is due to pandemic-related reasons like stay at home orders, people having to stay home to watch children whose daycares and schools are closed, and a reluctance to visit medical facilities, due to the possibility of being exposed to Covid-19. This latter has especially affected immunocompromised patients, who are important participants in many clinical trials.
● A recent pipette tip shortage, which resulted in testing delays and, in some cases, costly surcharges.
● An increase in online advertising costs. This is a good way to recruit survey participants, but rates have risen more than 24% since the summer of 2020.
● Protocol amendments. These changes, often brought on by the pandemic, have required making adjustments to procedures and documents, for an estimated average cost of about $2,000 per contract. This alone is a significant added expense, but if multiple sites are involved, it could hike this expense into the hundreds of thousands of dollars.
● A rise in patient retention expenses such as rental cars and hotel rates.
One solution that some companies have found is to decentralize clinical trials, or to make them virtual. But as the article points out, this also means new costs. For instance, in many cases, new technology would be used that involves purchasing computers and other equipment. Other expenses include online security and hiring IT staff.
On top of all of this, an additional problem for companies who’ve opted to go this route is an ongoing microchip shortage.
Sadly, the article doesn’t have much to offer in terms of strategies or solutions. Of course, after reading the list, it’s easy to understand why. It seems that price hikes, scarcity, and delays are a part of clinical trials for now, no matter what form they take.
The timing couldn’t be worse, as clinical trials are more important and more in demand than ever.
● a demand for clinical trials in developing nations
● a rise in the frequency of chronic conditions
● an increasing number of medications and treatments that need to be submitted to trial
● the expansion of the clinical trials market into treatment for severe chronic disorders like cancer and HIV
Precedence Research suggests another solution, that of using AI for predictive analytics. But is this a surefire way to get accurate results? This question is at least part of the reason why predictive analytics may not be approved by all regulatory authorities.
Ultimately, it may just be a waiting game. Hopefully, economic and supply chain issues will improve, and as the pandemic possibly dies down, more people will be able and willing to participate in clinical trials again. Until then, as MedCity News’s Katie Rothstein bleakly concludes, “delays in study conduct snowball into delays in getting critical, life-saving drugs to market.”