Integrated Sample Management › sites › default › ...Often this requires enrolling patients from multiple countries or geographical locations. A recent study showed 93% of trials

brookslifesciences.com

SAMPLE HUB SERIES: PART 1 CLINICAL STUDY TIMELINES

Accelerating Clinical Research with

Integrated Sample Management

INTRODUCTION

Sample Hub Series: Part 1

Drug discovery and development is a long road. It can take 10-15 years from discovery to regulatory approval of a new therapeutic.1,2 At least half that time is spent in clinical testing. The average clinical trial timeline is 6-7 years for non-oncology drug candidates and 13 years for oncology drug candidates.3,4

Reducing clinical trial timelines can create financial and ethical advantages. The longer it takes to develop a drug, the longer patients and physicians must wait for new treatment options. Longer clinical trials are also more expensive to run.5 It now costs between $161 million and $2 billion to develop and market a new therapeutic.2 It is becoming harder for companies to recoup those costs because most patents only protect intellectual property for 20 years.2 If drug development takes 10-15 years, or longer, this leaves just a few years for biopharmaceutical companies to cover development costs before the threat of competition and development of generics.

Many factors contribute to long clinical trial cycles. The aim of clinical trials is to demonstrate the safety and efficacy of a new drug in a specific patient population. Often this requires enrolling patients from multiple countries or geographical locations. A recent study showed 93% of trials funded through the Health Technology Assessment (HTA) Programme in the United Kingdom were multi-site trials, which take longer to set up and are more expensive than single-site trials. Clinical sample handling and testing is also more complicated in multi-site or multi-country trials. Furthermore, many companies are now testing new therapeutic candidates for age-related and chronic diseases. Longer trials are needed in these cases to assess long-term side effects. Patient and investigator recruitment is challenging in any clinical trial and can be particularly problematic in longer trials.6 Almost 50% of HTA-funded clinical trials have a delayed start date, caused by issues obtaining ethical and governance approvals or in staff recruitment.5

The biopharmaceutical industry is actively searching for ways to accelerate clinical trial timelines while maintaining patient safety and remaining compliant with regulatory guidelines. Proposed solutions include a central institutional review board (IRB) for multi-site trials that uses mobile technology and centralized sample handling.

2

IV

Phase 4Adverse events compliance, and

drug-drug interactions

drug products & cell therapy/regen

medicine products

III

Phase 3Confirm Efficacy &

Monitor Side-effects in Larger Population

Phase 2Efficacy & Dose

Ranging

III

Phase 1Safety & Tolerability

Clinical Trial Phases

CLINICAL TRIAL COSTS BY TIMELINES

In the age of personalized/precision medicine, clinical trials are becoming more complex – and companies are enrolling more patients, using more trial sites, and adopting longer treatment schedules to show adequate safety and efficacy profiles. These decisions impact clinical trial timelines. While Phase I cycle times have remained constant over the past decade, Phase II and III clinical trials now take 6-7 months longer than they did ten years ago.1

According to a study of over 185,000 industry and non-industry clinical trials from 2000 to 2015, Phase I studies take a median time of 1.8 years to complete. Phase II clinical trials take an average of 2.1-2.9 years, and Phase III trials take 2.5-2.8 years. Companies often must wait another 1-2 years between the end of a Phase III trial and drug approval.2,3,4

Clinical Study Timelines

3

CLINICAL STUDY DELAYS

Larger, multi-site trials are logistically challenging to set up and run, and are subject to issues with patient, staff and site recruitment, and sample handling workflows. These factors delay start time in up to 50% of clinical studies.5

Patient Recruitment

Many clinical trial sponsors now use biomarkers to stratify patients. The use of pre-enrollment biomarkers is associated with higher probability of success for all phases of clinical trials.3 However, biomarkers and other exclusion criteria such as comorbidities or concurrent medications can make patient recruitment difficult and time-consuming.2 Patient recruitment can also be delayed when enrolling patients in multiple countries, particularly emerging markets.7

Staff and Site Recruitment

Sponsors may also experience difficulties recruiting qualified clinical staff or competing for qualified clinical trial sites. Nearly 50% of clinical investigators quit after their first clinical trial. Due to the cost of running clinical trials, many clinical sites face financial difficulties.

The average US clinical trial site is $400,000 in debt.2 This is part of the reason some big biopharmaceutical companies partner with individual contract research organizations (CROs) to offset the cost of access to staff and sites.

Clinical Procedures, Sample Collection, and Sample Handling

A large challenge when running a multi-site trial is standardizing clinical procedures, sample collection, and sample handling to keep sample and data quality from becoming non-variable.

Preanalytical variables make it difficult to compare data across and between studies and may be a source of trial failure.8 Standardization is particularly challenging when using multiple vendors or CROs to analyse samples. Tracking and access to samples stored in central and speciality labs can also be very difficult, since these systems are set up for testing rather than sample management. Many sponsors have reported long delays in gaining access to samples.

Sample Hub Series: Part 1

4

The biopharmaceutical industry can streamline procedures to accelerate clinical trial timelines.

Centralized Ethics Approval

Ethics and governance approval can be a complicated process in multi-site trials. Protracted ethics approval can delay start times in up to 50% of trials.5 To address this problem, the United States Food and Drug Administration recently published guidelines recommending the use of a central IRB when running multi-site trials.9

Regulatory Harmonization

Regulatory guidelines differ in various countries around the world. The European Union is working to harmonize regulatory guidelines across the region to make it easier to run multi-country clinical trials.

The International Organization for Standardization (ISO) provides international standards to help global organizations standardize processes. They are developing an accreditation program for biobanks to help ensure evidence-based processes are used. This is expected in 2019.

Improved Patient Consent

Patient consent is an essential part of clinical trials and is required by regulatory agencies. It can take considerable time to inform patients of their rights, explain the study purpose and procedures, outline the risks and benefits of participation, and ask for consent to use samples for research.

As part of the Clinical Trials Transformation Initiative, a multi-stakeholder group came up with a variety of ways to improve the patient consent process: shortening patient consent documents; using easy to understand language, and implementing electronic consent documents.10

Mobile Technologies

Mobile technologies can lower clinical trial costs by allowing people to participate in some clinical trial activities remotely. These technologies can reduce some of the barriers to patient enrollment such as geographical location. Mobile technologies can also streamline patient consent, patient follow up, and data collection and management. Mobile technologies are yet to be widely used in clinical trials, and regulatory agencies will likely issue guidelines in relation to mobile technology use in clinical trials.

Centralized Sample Handling

During a clinical trial, samples are often analysed by multiple laboratories or CROs – each with different pre-analytical processes. This creates residual specimens that have been prepared using a variety of methods.

Centralized processing before sending samples to a testing lab ensures standardized methods are used in preparation, which means labs receive only those samples needed for testing.

Making smart use of lab services via a centralized solution accelerates research downstream and streamlines the entire sample process. Fewer touchpoints means less movement, while informatics handles samples to reduce admin time.

An integrated lifecycle management platform such as Sample Hub™ manages vendor relationships and standardizes sample handling processes to maintain sample quality and integrity – and accelerate clinical trial timelines.

ACCELERATING CLINICAL STUDY TIMELINES

Clinical Study Timelines

CONCLUSION

Clinical trials can take anywhere from 6-13 years and cost hundreds of millions of dollars. Biopharmaceutical companies can shorten clinical trial timelines by using central IRBs, simplifying patient consent, implementing mobile technologies – and centralizing sample handling processes. Shorter clinical trial cycles reduce trial costs and make new therapeutics available to patients sooner.

5

Cryopreservation & Cold Chain Solutions

Sample Storage, Lab Services & Transport

Automated Storage Systems

Informatics &Technical Solutions

Sample Consumables& Instruments

Learn more – www.brookslifesciences.com Contact us – www.brookslifesciences.com/contact-us © Copyright 2018 Brooks Automation, Inc.

Brooks Life Sciences, a division of Brooks Automation, (Nasdaq: BRKS) life science industry with the most comprehensive portfolio of sample management solutions, enabling researchers worldwide to accelerate innovation and improve patient provides

the health. The company offers automated storage, cryopreservation, informatics, sample storage, lab services, transportation, consumables and instruments. Technologies and entire cold chain supporting research, GMP, pre/clinical, cell therapy, and biologics. The top 20 biopharmaceutical providers and other leading companies rely on Brooks Life Sciences to advance

research.

REFERENCES

1. Martin, L., M. Hutchens, and C. Hawkins, Trial watch: Clinical trial cycle times continue to increase despite industry efforts. Nat Rev Drug Discov, 2017. 16(3): p. 157.

2. Sertkaya, A., et al., Examination of Clinical Trial Costs and Barriers for Drug Development. 2014, U.S. Department of Health and Human Services.

3. Wong, C.H., K.W. Siah, and A.W. Lo, Estimation of clinical trial success rates and related parameters. Biostatistics, 2018.

4. DiMasi, J.A., H.G. Grabowski, and R.W. Hansen, Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ, 2016. 47: p. 20-33.

5. Raftery, J., et al., Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme. Health Technol Assess, 2015. 19(11): p. 1-138.

6. Shea, K., Solving the Patient Recruitment Dilemma, in World Pharma Today. 2018.

7. Martin, L., et al., How much do clinical trials cost? Nat Rev Drug Discov, 2017. 16(6): p. 381-382.

8. NCI Best Practices for Biospecimen Resources. 2016.

9. Using a Centralized IRB Review Process in Multicenter Clinical Trials. 2018 [cited 2018 25 May 2018]; Available from: https://www.fda.gov/RegulatoryInformation/Guidances/ucm127004.htm.

10. Lentz, J., et al., Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials, 2016. 49: p. 65-9.

Learn more about Sample Hub™ Integrated Lifecycle Management from Brooks Life Sciences.

Sample Hub Series: Part 1 — Clinical Study Timelines

6