A Guide to Clear-Cut Planning and Program Execution

The landscape of clinical trials and other clinical development projects has dramatically changed in recent years. Progress made in scientific discovery is paving the way to novel therapies and compounds that seek to surpass existing drugs in efficacy and safety. 

But, innovation is not the only competitive driver. Concerns over an aging population and increased health needs add pressure to pharmaceuticals and biotech companies to develop new drugs and devices. And, that’s without the fact that an unknown virus can dramatically hit people worldwide, regardless of ethnicity, age and gender.

In view of that race to provide people with better medicine, planning clinical operations cannot be left to haphazardly implemented processes and “best-we-can” execution. Should your organization embark on a project without a plan, chances are that metrics, milestones, and budget won’t be met.

With that said, follow this step-by-step guide to reach success in your clinical studies endeavors.

Clinical Study Strategy

All 4 phases of clinical studies are important, but entering phase I with a long-term strategy in mind is crucial. Too often, these trials fail because of poor study design. 

Here are some questions to ask yourself as you approach phase I:

  • Are endpoints on point?
  • Can you meet data requirements? 
  • Are you equipped with data collection tools, academic research and published scientific work to make the right decisions?
  • Do you have the in-house work power to prepare protocols and study worksheets?
  • Are you up-to-date with informed consent procedures?
  • Did you designate one interlocutor to deal with regulatory agencies? 

There are hundreds of action items you will need to check off, including the research protocol, methodology, subjects’ selection (and exclusion), procedures, safety assessment, quality assurance, data collection and security.

 

Starting up the Study

Two of the main weak points in clinical studies are usually site selection and patient recruitment (or, in the case of non-oncology trials, healthy volunteers). Site selection involves visiting candidates to determine if they are suitable in terms of experience in specialty, experience in trials, staff, and any other criteria you deem qualifying. 

Site negotiation can often take longer than anticipated (up to 46 days compared to 19 for phase IV). As for patient recruitment, enrollment, and retention, those stages come with their own complications.

At this stage, you also need to get ready for IRB requirements and ethics committee review and approval. 

Clinical Monitoring Plan

Procedures and risk assessment are essential when you move to the human side of research.

  • Are protocols at risk of not being compliant?
  • Are subjects eligible as per regulatory requirements?
  • Is adverse event reporting methodology already in place (even at this early stage)?
  • Do you have a team in place to review incoming data and verify it?

Managing Clinical Data Input

Data starts pouring in, often mishandled by non-tech-savvy staff. Statistical analysis may be the poor parent in clinical trials, yet data is what makes or breaks a trial. Not all team members double as biostatistics analysts. If only one aspect of the study should be outsourced, it may be data collection and analysis. 

By the same token, the raw data you receive needs to be converted to compliant formats. Databases become the source of information that feeds submissions and reports.

 

Preparing Clinical Reports Medical Writing

Medical writers seek to organize and concisely present data analysis, information, discussions, opinions, observations, and more. At this stage, we answer questions such as:

  • How did the trial outcomes reflect and support the trial objectives? 
  • Are you ready to summarize patient assessment and data for every phase?
  • Do you have a clear grasp of the risk-benefit ratio to demonstrate your drug/device safety and efficacy?

Our team has worked with many pharmacovigilance organizations to ensure the communication of drug and safety throughout, as well as after, the clinical process.

Facing Challenges in International Trials

Complex as domestic clinical trials may be, conducting a study in several different countries is a whole other suite of challenges. 

Each country has its own set of guidelines and regulations. Keeping track of the differences (both in obligations and submissions requirements) can rapidly turn into a gigantic puzzle.

International logistics are more complex to streamline, importation regulations may create delays if not understood, and you may need to revise your methodologies to collect samples. Planning for supply access and distribution should take place well ahead of the starting point.

Translation requirements complicate program execution further. Every element of the study should be made available in the official language of the state if only to alleviate the risks of legal repercussions. Language barriers can result in ambiguous interpretations or plain misunderstandings. 

Everyone involved in the trial (participants, staff) must be able to fully understand all documents, instructions, safety guidelines, and marketing materials. This represents a major undertaking better left to more qualified translators than Google.

Entrusting Your Clinical Project to Skilled Experts

Treximo has been providing clinical operations services to various industries for over 20 years, helping organizations to bring their projects to fruition. 

Our consulting experience allows us to offer a wide range of solutions at all stages of clinical trials. Our services include:

  • Clinical pharmacology expertise
  • Site Selection / Feasibility
  • Clinical Monitoring Services
  • eTMF and CTMS Support
  • Site Training
  • Study Conduct
  • Clinical Program and Project Management

Contact us today if you’re ready to learn more about clinical trial planning and program execution.