Important new medications and therapies can't be created without clinical trials first. The objective of these research efforts is to determine the viability and usefulness of potential new treatments and medical equipment. Whether or not these products ought to be made available to the public depends heavily on the results of clinical trials.
Despite their critical importance, Clinical Trials (CTs) can be difficult to set up and finish, and there are still many unfulfilled requirements among CT stakeholders. There is a wide range of things that could use improvement, from increasing the number of trial researchers and participants to refining trial methods and raising public awareness.
Let's take a look at a few of them as they pertain to the pharmaceutical industry, medical professionals, and patients:
Pharma-related Challenges
The Expense of Creating a New Drug
Introducing a new medication to the market is estimated to cost around $1.3 billion on average. Preclinical expenses, capital costs, and the price of medications that never make it to market can drive the total cost up to $2 billion. Pharmaceutical companies are sometimes dissuaded from doing CTs due to the substantial financial commitment involved [1].
Conducting a CT is quite expensive.
The therapeutic field being researched has a significant impact on the cost of pharma CTs. Phase 1 trials in the United States cost an average of $1.4–6.6 million, Phase 2 trials cost an average of $7.0–19.6 million, and Phase 3 trials cost an average of $11.5–52.9 million [2].
Stringent rules and regulations
The beginning of a CT can be significantly slowed down by the countless regulatory and administrative prerequisites that must be fulfilled at every level of the process. In addition, rules might differ greatly between jurisdictions (e.g., the latest EU regulations on CT summaries). Hence, when pharmaceutical firms wish to execute multicenter/multinational CTs, they must adhere to the applicable regulations, allocate another budget for the additional needs, assign the work to the most suitable team, etc.
The time frame from protocol approval to the start of the trial:
From protocol approval to trial initiation, new CTs generally take more than 6 months. A trial's efficiency suffers as a result of the high expenses and lengthy delays associated with such delays.
Challenges in recruiting both patients and medical professionals
Several studies are abandoned due to a lack of volunteers. Evidence suggests that due to poor recruiting rates, CT timeframes have possibly quadrupled. It's important to note that the involvement of doctors in CTs is an issue as well.
Physician-Related Challenges
Selecting the best possible doctors for a CT's recruiting needs to be done with careful consideration of each candidate's specialty, academic background, and other relevant factors. This is not always simple, since doctors have several concerns about taking part in clinical research.
Lack of Awareness
Most doctors either don't know about the subjects of current trials. Some causes of this disinterest include research failing to adequately explain their clinical and scientific relevance. Some doctors are reluctant to take part in CTs because they don't understand the study methodologies and procedures involved, while others have trouble communicating with those involved in the trial.
Insufficient administrative support and training
Insufficient training for the involved physicians and their personnel tends to be a disincentive given the growing intricacy of clinical trials. They lose money because they have to spend time away from their clinical practice dealing with paperwork, clerical tasks, data management, etc., for which they receive inadequate administrative assistance. Participation in a CT also necessitates gatekeeping on the trial participants' behaves , which might place additional stress on already-busy doctors.
Poor incentives
Other factors that may discourage doctors from taking part in CTs include loss of professional autonomy, limited incentives, and inadequate rewards and recognition.
Patient-Related Challenge
Hesitation to Enroll
As was previously said, most CTs are unable to enroll study participants. Patients may be less likely to enroll in a clinical trial if they are unaware of the program, have trouble meeting the trial's strict eligibility requirements, are confused by the extensive paperwork involved in giving informed consent, or are unable to afford the study's out-of-pocket costs because of restrictions imposed by their insurance providers [3].
Clinical Research Management Services at Zanteris
Zanteris is an industry leader in clinical project management for the pharmaceutical and biotechnology industries. Among their many offerings as a clinical operations service provider is assistance with successfully developing, launching, and executing clinical studies for its clients.
Zanteris is there to make sure its clients employ the finest practices in your field. Zanteris's role as an FSP allows it to enhance clinical trials while relying on other parties for some but not all of the required infrastructure. Zanteris has full autonomy over all funding and resource allocation decisions while outsourcing important responsibilities to boost the standard of clinical trial analysis and operational processes.
