CLINICAL TRIALS
parties involved, according to their roles, by scheduling frequent video calls, which result in minutes (written and agreed), as well as exchanging emails, are crucial to keeping everybody updated. . Finding the right partner(s) to join the journey can be difficult. Therefore, choosing a clinical contact research organisation (CRO) with expertise in the field, able to manage a multisite clinical trial, with a large network (including KOLs), and finally with robust financial muscle (to allow stability during the trial) is imperative. The clinical CRO can present the company’s product, and convince physicians to join the trial. Investigators will meet to give their opinions on the trial design, and these discussions not only support essential fine-tuning but the frequent dialogue also helps build the trial team. Sponsors attending international and national medical conferences are also of great support, not only to present the product, but equally to increase awareness among the users (clinicians) and introduce the product to prospective investors as a potential blockbuster. There are many physicians interested in contributing to patient well-being and to curing diseases.
Having a robust patient recruitment strategy is integral to a trial’s success. What tips do you have for those conducting their first trial? • Perform a feasibility study: in this way, frequency of patient recruitment can be calculated and predicted.
• Take part in the PSV (pre-study visit), and address the recruitment rate provided during the feasibility study to have an up-to-date and realistic rate.
• Create easy-to-understand written information as part of the informed consent form (ICF), giving simple and relevant facts
“Finding the right partner(s) to join the journey can be difficult. Therefore, choosing a clinical CRO with expertise in the field, able to manage a multisite trial, with a large network, and finally with robust financial muscle, is imperative”
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to patients about the trial; ensure patients are well informed and dedicate sufficient time to answer any of their questions. Though the subject will not be paid for taking part in the trial, make clear in the ICF that the subject (or the accompanying person) will be reimbursed for (additional) travel expenses.
• Focus on the retention of patients by working closely with KOLs, investigator nurses and the patients themselves to help mitigate this risk. Get to know the weak points involved. These might include inconvenient location, schedule conflicts, personal/family matters, physical inability, financial constraints, lack of appreciation, forgetting visits, fear and anxiety, condition not improving, side effects, refusal to comply or misunderstood expectations.
With the pandemic changing the way trials are conducted, what have you and your team done to ensure your trials were able to run, and do you feel these changes will be permanent fixtures in running a trial?
As with other pharma companies, our activities were affected by the COVID-19 pandemic and new deadlines had to be set up. It is also important to understand how the sites are conducting their workload activities, such as surgeries and appointments, in order to be in line with the new clinical trial landscape. EMA’s guidance on the management of clinical trials during the pandemic is an important helpful document (
https://ec.europa.eu/ health/sites/default/files/files/eudralex/vol-10/ guidanceclinicaltrials_covid19_en.pdf). We and our clinical CRO have our own Business Continuity/ COVID Contingency plan in response to the global pandemic. With these plans and risk mitigation for COVID-19-related risks in place, we are positive that we will start the Phase 1 trial in the Q1 2022 and can steer through these challenging times.
What long-term changes are likely to modify oncology trials as a result of the pandemic? • The snowball effect: surgeries, treatments and clinical trials have been delayed since the pandemic started and this will consequently affect upcoming trials. Therefore, it will take quite a while for everything to adjust to the new normal.
• Risks of new pandemics.
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