Professional Suggestions for Protocol Writing

September 28, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Scientific Analysis Scientist  │ Medical Writing Providers

Nice information; your crew has been given the inexperienced gentle to conduct a brand new scientific research together with your favourite compound!  It’s what you’ve been ready to listen to, and now it’s time to grab the chance and run full steam forward!

However first, you need to write a protocol.  The fundamental construction and content material of a protocol are described within the Worldwide Council for Harmonisation Good Scientific Observe E6 guideline.  As you’d anticipate, protocols ought to finally define and justify the deliberate scientific research.  The kind of data offered in protocols consists of background data, trial aims and assessments, trial design, topic choice and therapy, and a quick overview of the deliberate statistical analyses.

It could appear that writing a protocol could be fairly simple.  In spite of everything, how laborious is it to state what you wish to do?  However there are sometimes sudden hurdles within the design and improvement of a scientific trial, which may trigger delays within the protocol-writing course of.  On the similar time, there may be ceaselessly a way of urgency to finish the protocol, both as a result of it’s needed for the submission of an IND or as a result of there’s a rush to provoke the trial itself.

Collectively, these problems can gradual protocol improvement or necessitate subsequent amendments.  We’ve seen it occur, and through the years, we’ve provide you with a couple of tricks to make writing a protocol a bit simpler.

Picture courtesy of renjith krishnan at Freedigitalphotos.web.

1. Perceive the place your research suits in

It is very important perceive the place your research stands when it comes to the general drug program.  Will your research be included in an upcoming submission?  Will your research depend on the outcomes of earlier research?  What elements of your research are more likely to be most necessary in informing future research?

Addressing these questions might help decide the timelines on your mission and can even assist preserve the crew centered on the “huge image” points.

2. Assemble a crew and decide research objectives

It’s essential to assemble a crew that may deal with all elements of a protocol, from drug formulation to regulatory necessities to security/efficacy/pharmacokinetic analyses.  As you’re placing your crew collectively, keep in mind to establish people who’re key resolution makers or who might help resolve potential disagreements throughout the crew.

Enter from numerous crew members is what finally determines how a protocol is written, and forgetting or neglecting a given space of experience is understandably problematic.  Forgetting to incorporate a crew member from a given practical space usually implies that you’ll have to solicit enter from that practical space at a later date.  And that normally interprets to further effort wanted to re‑write parts of the protocol, in addition to delayed timelines whereas the enhancing takes place.

As soon as your crew is assembled, you will need to just remember to all agree on the identical research objectives.  Is that this a bioequivalence research?  Are you looking for a Part 2 dose or confirm efficacy in a chosen inhabitants?  These questions could seem apparent, however completely different crew members usually have completely different opinions on what data ought to finally be derived from a research.  Getting everybody on the identical web page at an early date can stop confusion and re-writing additional down the highway.

3. Create a protocol idea

One other glorious option to stop re-writing and to simplify timelines is to create a protocol idea.  A protocol idea is a brief (normally <15 pages lengthy) doc that briefly outlines key research elements, comparable to trial design, inclusion/exclusion standards, aims, and assessments.  This isn’t a regulatory doc and there’s no customary format: it may be so simple as a collection of bulleted lists!

A protocol idea needs to be reviewed and/or accredited by the crew earlier than formal protocol writing begins.  This enables the crew to evaluation the “huge image” points in a small, condensed format, which is often extra environment friendly than asking the crew to evaluation a full-length protocol.  Acquiring crew settlement on the protocol idea then streamlines protocol writing, and minimizes the danger of needing massive scale edits within the protocol itself.

4. Fastidiously think about your research design

Okay, this one sounds fairly apparent, however there could be a shocking variety of elements at play.  As an example, do you want a placebo or an lively comparator on your research?  Do you have to look at multiple dose stage of your drug?  Contemplating the character of the drug and the illness in query, what assessments and time factors needs to be used for evaluation?

As I discussed earlier, that is one space the place a protocol idea is particularly helpful.  Figuring out the research design upfront reduces the chance that the research design might be adjusted throughout protocol writing, which in flip streamlines the manufacturing of the protocol.  As you’d anticipate, trials can get extra advanced on the later phases of improvement, which makes it all of the extra necessary to get all crew members on the identical web page as early as doable.

5. Don’t overlook the practicalities of research design and conduct!

It’s very true that the satan is within the particulars.  There are a whole lot of potential pitfalls in research design, however there are some points which appear to recur with startling frequency.  As an example:

And I do know I mentioned it earlier, nevertheless it bears repeating: keep in mind your research objectives!

It may be tempting to attempt to reply as many questions as doable in a single research.  However unnecessarily complicating a research could be problematic, each when it comes to administrative burden and when it comes to including potential confounding variables that will impede the interpretation of knowledge.

6. Keep in mind Your Writing Concerns

Except for the research design, there are a couple of further issues to remember in the course of the writing course of.  For one factor, it’s at all times useful to start protocol writing utilizing an organization template, or utilizing a mannequin protocol from the identical (or an identical) scientific program.  In a pinch, it could be doable to adapt on-line templates on your personal use.  For instance, the NIH has generated a publically-accessible protocol template that was designed for Part 2 and Part 3 scientific research.

I’ve already talked about the significance of figuring out your crew and utilizing a protocol idea to frontload the work.  Moreover, it could be helpful to have a chosen social gathering evaluation the protocol for feasibility.  A scientific knowledgeable or the CRO chargeable for conducting the research (if relevant) ought to be capable of advise the crew on whether or not there are more likely to be points implementing the brand new research design.

One other subject that we regularly see is the will to write down 2 protocols in parallel (particularly for 1 drug that might be used for a number of indications).  However writing in parallel could make it laborious to generate consistency between paperwork.  Parallel writing additionally will increase the general workload for all crew members, which may make it tougher for crew members to present every research the complete scrutiny that it wants.  Collectively, these points can necessitate substantial edits (and potential delays) within the later writing phases.

As a substitute, we propose staggering protocol writing.  Begin writing one protocol and permit it to progress by not less than 1 draft (ideally 2 drafts) earlier than beginning the second protocol.  That approach, the general construction/messaging of the primary protocol could be pulled immediately into the second protocol and the crew can deal with one doc at a time.  This staggered course of usually permits the second protocol to be written way more shortly than the primary, and we’ve discovered that staggering protocol writing doesn’t essentially delay doc finalization relative to writing the protocols in parallel.

7. Contemplate deliberate amendments

Understandably, many groups wish to reduce protocol amendments.  However each from time to time, pre‑planning amendments could be a very useful software to extend the quantity of helpful information obtained in a research and to streamline the scientific improvement program.

Pre-planning an modification could be achieved informally, however it’s essential to find out what standards should be met to set off the submitting of a selected modification.  A simple instance could also be so as to add dose cohorts if a most tolerated dose shouldn’t be reached.  However amendments can also be used to accumulate further information to tell future research.  As an example, if a sure share of sufferers don’t meet a chosen efficacy endpoint, maybe a further endpoint (or time level) could also be added to the research.

Good luck!

All proper, that’s only a few recommendations on the best way to streamline your protocol-writing processes.  Don’t hesitate to contact us in case you have any questions or if we could be of any assist!  We’d additionally like it should you observe us on LinkedIn and Twitter.

Class: Medical Writing Providers
Key phrases:  protocol improvement, research design, research planning

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