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advice on what to expect and how to prepare

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The Guideline for Good Clinical Practice – an international ethical and scientific quality standard covering aspects of the design, execution and reporting of clinical trials – has not been revised since November 2016. Considering all the changes that the field of drug development has seen in almost every corner of the ensuing six years, it might be time for an update.

Many operations struggle to understand and implement these standards. To learn more, Outsourcing-Pharma spoke with Sonia Araujo, Head of Product Management for LifeSphere Clinical at ArisGlobal.

OSP: Could you please share some of the ways the drug development industry’s understanding of the balance between advancing treatments and protecting patient safety has evolved over the years. year ?

SA: For pharmaceutical companies, being first to market with a new drug has long-term financial benefits and increased market share. Therefore, any delay in conducting their clinical trials and obtaining their marketing authorization may negate this potential benefit.

For patients, any delay in bringing medicines and treatments to market can affect both their economic prospects and their health; maybe the difference between life and death for some people. As citizens, we have all seen in the media when clinical trials have gone wrong, or even when a drug on the market has had significant adverse effects in the general population. Advancements in technology mean that we are all more “in the know”. We understand our health data, we expect a certain level of patient care, and we want faster results.

And then there was COVID-19! The pandemic and the need for vaccines and drugs in record time has proven (in my eyes) that this industry can move faster while maintaining rigorous safety controls.

OSP: How have regulatory agencies such as the FDA and EMA kept pace: did they serve as a leading voice/resource, did they fall behind a bit, or a mixture of both?

Sonia Araujo, Head of Product Management for LifeSphere Clinical, ArisGlobal

SA: The complexity of clinical trials has increased dramatically over the past 20 years. According to Ken Getz and Rafael Campo​, the number of procedures per patient over the 2011-2015 period jumped between 53% and 70% (depending on the study phase) compared to the 2001-2005 period; and the number of patient visits increased by 25-29%. That’s a lot of data to manage, for sponsors and their CROs, as well as regulatory agencies.

We all sometimes have issues with regulators, but overall I think they have maintained a good balance between patient safety and getting medicines to market faster. Embrace regulators’ move towards risk-based approaches – it really helps sponsors and CROs focus on the things that matter.

Another example is the new European Union (EU) regulation on clinical trials which came into force earlier this year. Yes, I know, several years later than the original plan. But now that it’s out, there are several things that should speed up clinical trials and ultimately have a positive impact on patients.

For example, prior to the regulation, sponsors conducting trials in multiple EU member states had to submit clinical trial applications separately to national competent authorities and ethics committees in each country, in order to obtain approval. regulations for their trial. Now sponsors only need to submit a single application to conduct a trial in multiple EU countries.

OSP: How have technology tools like CTMS helped?

SA: A modern clinical trial management system (CTMS) helps clinical operations teams accelerate timelines through better planning, stay organized, and reduce complexity. A CTMS facilitates better cross-functional collaboration between clinical operations, data management, and other teams to identify critical risks affecting trial quality or patient safety. Clinical teams can uncover hidden study risks with industry-standard questions and score study risks based on likelihood, impact, and detectability. As a result, a more airtight risk plan strengthens a clinical study report and ultimately increases study success.

OSP: What other technological advances have helped to design and run more efficient and safer trials?

SA: Trial master files (TMFs) play a crucial role in the success of clinical trials, and the evolution of electronic TMFs only improves the process. eTMF systems provide the automated tools and capabilities needed for the most efficient clinical operations by aligning clinical documentation with regulations and study protocols into a single source of truth.

An eTMF system also streamlines TMF inspections to handle complex audits quickly and efficiently. Maintaining compliance with built-in workflows and dashboards enables easy reconstruction of trials. And let’s not forget the sites and their equivalent investigator site file (ISF). When the site’s eISF is integrated with the sponsor’s eTMF, compliance compliance and efficiencies multiply for both stakeholders. It’s also an example where technology can support stronger relationships between sponsors, CROs and venues.

OSP: Could you please tell us about the GCP guidelines? How have they supported the design and execution of clinical trials in the past, and what is covered in the reviews this time around?

SA: GCP standards help organizations control quality while developing cutting-edge medicines. The ICH plans to publish a revision of the GCP guidelines in August 2023 – the ICH E6 (R3) guideline. As before, the guideline will describe the responsibilities and expectations of all stakeholders in the conduct of clinical trials.

The review focuses on two goals – ensuring patient safety and maintaining data integrity – recognizing the increased diversity of trial designs and data sources. Various sources of data – such as trials using master protocols, adaptive clinical trials and decentralized clinical trials – continue to grow in number. Health authorities fear that this diversity of data could introduce new risks. ICH wants to ensure that these risks do not outweigh the benefits of new drugs and medical devices.

OSP: Please talk about some of the barriers that small operations face in this area.

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(Andrew Brookes/iStock via Getty Images Plus)

SA: Smaller life science organizations sometimes struggle to meet GCP guidelines due to limited resources, time constraints, and budget issues. For example, it is common for staff in small organizations to wear many hats and sometimes without the collective knowledge base present in large pharmaceutical companies. Often multiple spreadsheets and documents are used to monitor milestones and manage risk to reduce costs.

Other common obstacles include an immature data infrastructure and the fear that operationalizing a digital strategy could hamper productivity and negatively impact their level of competitiveness. Hiring CROs and ISVs who know best business practices can help small organizations overcome these hurdles.

OSP: What about useful technologies? Are they increasingly accessible to smaller or more inaccessible operations?

SA: Today’s technologies such as CTMS, eTMF and EDC systems help organizations of all sizes achieve their goals and stay compliant. They contribute to risk management, cost reduction, efficient conduct and safety of clinical studies. We have seen an increase in the number of software vendors for these solutions, which has made the technology available to more organizations, more targeted to the needs of different organizations, and at different price points.

Clearly, if organizations want to make progress in the life sciences industry, they cannot afford to stay disconnected throughout the process. A key consideration for small organizations would be to find a solution that is scalable and can grow with their changing needs.

OSP: How can a company like ArisGlobal help operations of different sizes succeed and compete with the bigger ones?

SA: Small and medium-sized farms feel the pressure when they bring their first therapies to market. With deadlines fast approaching, an organization’s success and momentum depends on its preparation. By using our LifeSphere platform, a company is rooting itself in a technology partner who will grow with it and support it through every crucial stage of research and development. LifeSphere streamlines countless data sources, improves the efficiency of distributed teams, and ensures compliance with global regulatory agencies.

OSP: Do you have anything to add?

SA: To quote the ICH, “Clinical trials must be conducted in accordance with ethical principles which have their origins in the Declaration of Helsinki and which are consistent with good clinical practice (GCP) and applicable regulatory requirements”. Nowadays, much more data is gathered during clinical trials, which guarantees better results but poses problems for sponsors, CROs, sites and regulators.

Despite this, patient safety remains paramount! Our industry has powerful technology to partner with to ensure that clinical trials are expedited by reducing risk, while remaining compliant with guidelines and regulations such as the upcoming ICH E6 (R3) guideline. CROs play a vital role in this commitment, ensuring that our industry thrives for the benefit of all stakeholders.