Biotechnology has been responsible for some of the most significant clinical discoveries in human history. Engaging in arduous clinical trials is a critical step of this process. There are different phases to clinical trials, with unique challenges at every step of the process.
Drug discovery is costly and labor-intensive, so it’s essential that biotech sponsors meet the challenges and find solutions to minimize the consequences. When biotech sponsors partner with contract research organizations (CROs), they can execute more efficient trials while solving the challenges they face.
The Biotech Industry: An Overview
Biotechnology, in relation to medicine and healthcare, refers to a science-driven industry that integrates biology with engineering to create healthcare products. Recently, it has risen in popularity for its applications in clinical treatments.
The science itself involves the use of living organisms and their derivatives to create products, such as medicines. It combines a number of disciplines, including biology, physics, chemistry, and engineering. Modern biotechnology has led to plenty of breakthroughs in clinical research, such as the discovery of penicillin by Alexander Fleming.
Since its rapid rise in the 19th century following Gregor Mendel’s study of genetics, biotechnology has taken off and transformed the landscape of healthcare. Some highlights in biotech include the discovery of DNA structure, the synthesis of insulin, the development of biotech vaccines, and the completion of the human genome sequence.
Both biotechnology and pharmaceutical companies produce medicines and treatments, but the bases of these medicines differ. Biotech companies derive their drug development from living organisms, while pharmaceutical companies base theirs on chemicals and compounds.
Challenges in Biotech Clinical Trials
Biotech sponsors face many unique challenges once they reach the clinical trial phase of drug discovery and development. These challenges can cost sponsors millions of dollars in resources and labor, as well as set back the trial by days to months to years. Below is a list of the seven main challenges biotech sponsors face when conducting clinical trials.
#1 — Site selection
Choosing a site is critical to the success of a clinical trial since it affects patient diversity and recruitment – the foundations of the trial itself. Sponsors face the issue of balancing thorough, quality evaluation with meeting deadlines so as not to delay the trial. Clinical trial sites must be accessible, fully equipped and staffed, and strategically located.
#2 — Patient diversity and recruitment
Patient recruitment is a major challenge for any clinical trial, especially when there are unrealistic timelines and mismanaged expectations. 11% of clinical trial sites fail to recruit a single patient, and a further 37% fail to meet their enrollment goals. Patient recruitment is critical to the success of a study.
Patient diversity is also a crucial issue that clinical researchers are still trying to address. Medications can affect demographics in different ways, so it’s essential for sponsors to recruit a diverse pool of patients to ensure equitable participation.
#3 — Regulatory constraints
Clinical trials need to comply with regulatory requirements from authoritative bodies such as the Institutional Review Board (IRB) and the Independent Ethics Committee (IEC). This involves submitting the necessary documents and awaiting approval. Negotiating what forms and documents to submit can be difficult for biotech companies whose primary focus is research and development – all the more if the trials are outsourced.
#4 — Clinical trial costs
Budgeting and funding are challenges inherent to clinical research, especially for those using the traditional FTE (full-time equivalent) pricing model. And since clinical trials are not static, change orders – which are requests for alterations in the scope of the trial – can inflate the costs beyond the initial dedicated budget.
#5 — Vendor and supply coordination
Clinical trial sites are responsible for coordinating with suppliers for lab kits, drug sources, electronic devices, and other materials required for testing. Delays and miscommunication can seriously impact a trial in its testing phase, and may even compromise the trial entirely. There is also the risk of getting scammed through artificially-raised prices or non-delivery of materials.
#6 — Technology and access
Technology plays a key role in clinical trials, particularly now with innovations transforming the landscape of medical research. From artificial intelligence (AI) to electronic data management, new technology has streamlined the process of drug development and made processes more efficient. However, these technologies come with their own risks and challenges – especially in terms of access, usage, and application.
#7 — Protocol compliance and deviation
Patients can miss doses or fail to submit their personal records, regardless of whether the study is conducted on-site or remotely. They may not fully comply with the parameters of the study, especially if they do not fully comprehend the necessary information and processes involved.
How CROs Solve Biotech Challenges
Many of the challenges that biotech sponsors face can be solved through partnerships with CROs. Both full-service and niche CROs offer a variety of services that address key issues in drug development and clinical studies, to the benefit of both sponsors and patients.
#1 — Site evaluation and selection
CROs work with sponsors to evaluate potential clinical trial sites. A good CRO will know the appropriate questions to ask during site selection and assess whether the facilities are appropriate and optimal for the study. This includes weighing the historical performance of the site, its clinical research experience, and the feedback from previous participants.
Furthermore, many CROs will have built relationships with sites to establish a preferred site network consisting of highly experienced, quality investigators. Site networks are highly valuable for sponsors as it connects them to sites that have already undergone a comprehensive selection process.
#2 — Recruitment plans and eligibility criteria
One way to mitigate the risks and difficulties associated with patient recruitment is to have a realistic, well-thought-out recruitment plan. CROs work within conservative estimates, use multi-channel marketing tactics, and leverage advanced technology to identify and recruit patients who fit the eligibility criteria. Finding a CRO that has a patient recruitment playbook will help with recruitment challenges.
#3 — Regulatory compliance
A competent CRO will be well-versed in all the required documentation and paperwork needed for clinical trials to proceed. The CRO can file the documents with the relevant regulatory bodies through the correct channels and can inform sponsors of the expected timelines for approval or appeal. It can even work with a tech-enabled approach versus analog and paper-based ones, which are slower and less efficient.
#4 — Fixed-fee pricing
A fixed-fee pricing model offers numerous benefits for sponsors with a tight budget. A fixed-fee pricing model guarantees a set budget for the entirety of a project based on the final protocol, instead of charging per full-time, billable hours of labor. This prevents budgets and associated costs from inflating beyond the funding capacity of the sponsor – particularly if they are a start-up or a smaller company. Fixed-fee pricing models also help sponsors maximize ROI and reduce the need for change orders.
#5 — Vendor and supply management
External vendor coordination falls under the purview of both the clinical trial facility and the CRO. The two parties will coordinate to gather production timelines, supply availability, and delivery routes, and integrate this information into the trial’s schedule. This ideally takes place before patient recruitment begins, so that the study and staff have the correct resources in place to onboard patients and/or volunteers.
#6 — Technological innovations
Utilizing modern technology to streamline clinical trial processes will pave the way for greater efficiency, higher accuracy, better accessibility, and improvements in patient diversity and inclusion. Selecting a CRO that is using the latest technology can save sponsors time and money. For example, Vial uses eSource as a replacement for paper-based data capture and management. The implementation of this technology ensures data quality, heightens compliance, and eliminates errors in collection and processing.
#7 — Patient monitoring
CROs partner with site staff in clinical trial facilities to monitor patients and ensure compliance with the study’s parameters. They can use several methods, such as ePRO –electronic patient-reported outcome, an electronic system that allows patients to directly report their health status. By making reporting more intuitive and accessible, patients are more likely to comply with data submission and reporting. Patient participation and retention are a critical and significant challenge for many studies. A good CRO partner can help alleviate these challenges through patient-centric studies, modern technology, and proper monitoring.
Biotech Partnerships with CROs
Partnerships between biotech sponsors and CROs will help make clinical studies easier, and will save the sponsors time and money in the long run. CROs (such as Vial, IQVIA, Parexel, MedPace, PPD) are also uniquely equipped to address and solve the challenges that crop up during the clinical trial stages. This results in clinical trials that are more efficient, with maximized ROI and mitigated risks.
Vial is an industry-leading CRO powered by next-generation technology, that aims to reimagine the landscape of clinical trials. Our expert ClinOps members and tech leaders are the backbone of our organization, helping deliver faster, better, and cheaper results for biotech sponsors.
Request a proposal from us for your clinical trial today!